Evolut Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. The Evolut TAVI platform has also received a new indication approval for the treatment of patients with bicuspid aortic valves [...]
Picso system Miracor Medical has announced the award of the CE mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior STEMI patients. It says the new system features improvements in ease of use. PiCSO therapy is delivered during primary percutaneous [...]
Cobalt ICD Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals with heart failure, [...]
Treo stent graft Terumo Aortic has announced that the FDA has granted approval of the Treo abdominal aortic stent-graft system for sale in the USA for the treatment of patients with abdominal aortic aneurysms (AAA). According to a press release, Treo is the only device commercially available for endovascular aneurysm repair (EVAR) with dual [...]
Aspire MAX mechanical thrombectomy system Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from peripheral vessels. “This FDA clearance quadruples our product offering and improves our ability to help patients,” said Shawn Fojtik, president [...]
LifeSignal remote monitoring patch LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings. Patient data can be transmitted wirelessly [...]
TherOX DS2 ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction [...]
Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led [...]
Cerus Endovascular has received CE mark approval for its 0.021-inch Contour neurovascular system, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. According to the company, the Contour neurovascular system is a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination [...]
Terumo Europe today announced that their BioPearl microspheres have received CE mark, providing a new option for patients eligible for locoregional embolization for the treatment of liver cancer. BioPearl microspheres are designed to preserve post-transarterial chemoembolization (TACE) target artery access, opening up the potential for cyclic treatment. Currently, drug-eluting microsphere TACE (DEM-TACE) and conventional TACE are both [...]
VisCardia, Inc. VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A press release reports that VisONE has now completed the first phase of the [...]
Tack Endovascular System (4F) Intact Vascular has received FDA approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from Intact Vascular’s Tack Optimised Balloon Angioplasty II BTK (TOBA II BTK) clinical [...]
Axonics has announced the FDA approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval (PMA) supplement. This next-generation implantable neurostimulator decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour. This compares to the current recharging interval which is [...]
The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. A [...]
TriClip Abbott has received the CE mark for its TriClip transcatheter tricuspid valve repair system and is now approved for use in Europe and other countries that recognise the CE mark. It can, therefore, be used as a non-surgical treatment for people with a leaky tricuspid valve. A press release reports that [...]
COVID-19 Abbott has announced that the FDA has issued Emergency Use Authorisation (EUA) for the its molecular test for COVID-19. According to a press release, Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the USA. The tests are used on the company’s m2000 RealTime System. The [...]
TherOX DS2 Zoll has received FDA approval of the second-generation TherOx system, which—a press release reports—provides super-saturated oxygen (SSO2) therapy. SSO2 therapy is designed to deliver hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularisation via angioplasty and stenting of the blocked coronary artery. The press release [...]
In February, Abbott received FDA Breakthrough Device Designation for a fully implantable left ventricular assist device, Biotronik received the CE mark for its Osiro Mission drug-eluting stent, and BlueGrass Vascular Technologies got a FDA de novo classification order for its Surfacer Inside-Out access catheter system. CE marks CE mark—Fist compression device (Fist Assist Devices) [...]
Hero Access Vascular has announced that it has received clearance from the FDA for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and the potential to significantly reduce catheter occlusions. PICCs have become an increasingly popular [...]
Fist Assist Devices has received the CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other countries that recognise the CE mark. According to the press release, Fist Assist is the only wearable, patent-protected, intermittent compression device to increase vein diameter prior to [...]
Cardiovalve has received FDA approval for an early feasibility study of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation indication; the Cardiovalve system also has been granted Breakthrough Device Designation status by the FDA. Cardiovalve commenced its study for tricuspid regurgitation in the USA earlier this year. The study’s primary endpoint is [...]
SuperMap (Acutus Medical) Acutus Medical has announced FDA clearance of SuperMap, which a press release calls a revolutionary addition to the company’s AcQMap 3D imaging and mapping system. It adds that SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. Furthermore, SuperMap’s user interface effortlessly guides electrophysiologists to [...]
Gallant Abbott has received the CE mark for the new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices, which—a press release reports—have the most advanced heart rhythm management capabilities along with a new set of benefits to people in Europe with abnormal heart rhythms and heart failure. The [...]
Bluegrass Vascular Technologies (BVT) has announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. A press release reports that the Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions [...]
Orsiro Mission Biotronik now has the CE mark for its Orsiro Mission drug-eluting stent system. According to a press release, the next-generation of the company’s ultrathin strut Orsiro drug-eluting stent provides higher deliverability than other contemporary stents. The press release states that the Orsiro Mission “has a completely re-engineered delivery system to [...]
Caption guidance Caption Health has announced that the FDA has authorised marketing of Caption Guidance software, which is designed to assist medical professionals in the acquisition of cardiac ultrasound images. The system uses artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of images. The aim is to empower healthcare [...]
XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing [...]
The FDA has granted Breakthrough Device Designation for the Aria CV pulmonary hypertension system (Aria CV PH System). A press release reports that Aria has already performed a successful acute first- in-human clinical study in Vienna, Austria, and is now preparing for a US clinical trial under the FDA’s early feasibility study programme to [...]
Robert Kormos The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director for mechanical circulatory support at Abbott), the company to “fast track” [...]
MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 [...]
Cobalt ICD Medtronic has received the CE mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). With the launch of the Cobalt and Crome platform, Medtronic also is making TriageHF technology available. A press release reports that this technology assesses patients’ heart failure risk through [...]
AccuCinch The FDA has approved an expansion of enrolment of the CorCinch HFrEF early feasibility study, which is evaluating the AccuCinch ventricular repair system (Ancora Heart) for the management of patients with reduced ejection fraction heart failure (HFrEF). This expansion allows Ancora Heart to double patient enrolment from 15 to 30 patients and [...]
The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy treats significant mitral regurgitation in patients requiring a heart valve replacement and provides a safe [...]
This month, Medtronic has received FDA approval for its Micra AV system and for its Stealth Autoguide system. Also, the FDA gave the company the nod to proceed with an investigational device exemption (IDE) trial to evaluate a pulsed field ablation (PFA) system. Other approvals in January include a FDA green light for a [...]
A press release reports that the FDA has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare providers in the USA to more accurately screen for heart conditions during routine physical exams. If left undiagnosed, these heart conditions can lead to stroke and heart failure. According to the [...]
Vivek Reddy At the AF Symposium 2020 (23–25 January, Washington, DC, USA), Vivek Y Reddy (Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, USA) reported that pulsed field ablation (PFA)—with the Farawave (Farapulse Inc.) catheter—may be a feasible and safe approach for treating patients with persistent atrial fibrillation [...]
BioVentrix BioVentrix has received an extension of its CE mark for the Revivent TC transcatheter ventricular enhancement system to May 2024. The company received its initial CE mark in 2016. Less invasive ventricular enhancement (LIVE) therapy uses the Revivent TC system to exclude scar tissue on the left ventricle that has occurred [...]
Teleflex has received 510(k) clearance from the FDA for its Wattson temporary pacing guidewire. A press release reports that this is the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty. It adds that this “innovative device” offers clinicians a 0.035” pigtailed [...]
Medtronic has received FDA approval of Micra AV, which a press release describes as “the world’s smallest pacemaker with atrioventricular (AV) synchrony”; the pacemaker is indicated for the treatment of patients with AV block. The press release states that Medtronic “now offers the first and only FDA-approved leadless pacemaker portfolio, expanding the number of [...]
Opsens has received 510(k) clearance from the FDA to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as fractional flow reserve and diastolic pressure ratio (dPR). According to a press release, the OptoWire III is the latest version of OptoWire and the OptoWire family of products are used to diagnose [...]
Morph DNA BioCardia has announced that the FDA has granted 510(k) clearance for the Morph DNA deflectable guide catheter, which is used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. The Morph DNA deflectable guide catheter, a press release reports, is designed to enhance procedural [...]
MedAlliance has now been granted FDA Breakthrough Device Designation status for its Selution sustained limus release (SLR) sirolimus-eluting balloon for an arteriovenous fistulae indication. The company has previously received similar status for the coronary in-stent restenosis and peripheral below-the-knee indications of the balloon. According to a press release, Selution’s technology involves unique micro-reservoirs made [...]
The FDA has approved a new alternative surgical technique for the HeartMate 3 heart pump (Abbott) that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 left ventricular assist device [...]
WEB aneurysm embolisation system MicroVention (Terumo) has received FDA premarket approval (PMA) for the WEB aneurysm embolisation system for the treatment of intracranial wide neck bifurcation aneurysms. A press release states that the WEB system is the first and only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm [...]
JenaValve JenaValve Technology has received “Breakthrough Device” designation from the FDA. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The company is the sponsor of a US investigational device exemption (IDE) trial and is conducting a multicentre clinical programme for the treatment of patients with [...]
MitraClip XTR The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, the trial has the potential to [...]
Penumbra has announced FDA 510(k) clearance for expanded indication of its Indigo aspiration system. As part of the system, Indigo aspiration catheters and separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and now for the treatment of pulmonary embolism. Penumbra introduced [...]
Alucent Biomedical has received FDA approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial disease of the lower extremities. The Alucent NVS vessel restoration system with photoactivated linking combines standard angioplasty with [...]
Reflow Medical announced that its Temporary Spur stent system—novel retrievable stent technology intended for the treatment of below-the-knee peripheral arterial disease—has been designated for the Breakthrough Devices Program by FDA. The Temporary Spur stent system is a novel combination device that consists of consisting of a retrievable stent system. The system has a series [...]
The FDA has cleared the Stealth Autoguide system (Medtronic), which a press release reports is the first cranial robotic platform to integrate with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or tool [...]
Life Spine has received FDA clearance to market its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. The system comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6 degrees, 12 degrees and 18 degrees and heights ranging from 11mm to [...]
Eko DUO digital stethoscope Eko has announced that the FDA has granted the company breakthrough status for its ECG-based algorithm that is designed to provides easily accessible screening test for heart failure. A press release reports that the algorithm analyses 15 seconds of ECG data collected from the Eko DUO digital stethoscope during [...]
Each month, BIBA Briefings compiles a list of market approvals (European or US), FDA Device Designations, and recalls. For example, in December 2019, Cryolife received CE marks for two stent grafts (E-nya and E-nside), EOS imaging received 510(k) clearance from the FDA for its new generation imaging system (EOSedge), and Aleva Neurotherapeutics was awarded [...]
Thrombolex has received FDA clearance for its Bashir endovascular catheter—Short Basket (BEC S-B). The indication for use of the BEC S-B is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. A press release reports that Thrombolex provides an innovative line of endovascular catheters, which feature a unique [...]
DirectSTIM Aleva Neurotherapeutics has been awarded the CE mark for its—a press release reports—flagship product, the directSTIM deep brain stimulation (DBS) system. According to the press release, Aleva’s revolutionary DBS system incorporates directional electrode technology and is designed to be more precise and efficient, with optimised stimulation that will potentially reduce side [...]
Sapien 3 Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval for their devices to be used for low-risk patients in the [...]
Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]
VivaLNK VivaLNK has received a Class IIa medical device CE mark for its multivital medical wearable sensor and software development kit (SDK). According to a press release, at only 7.5grams, the reusable patch is the smallest of its kind. The press release states that the patch’s reusability factor can increase the economic [...]
i:X MolecuLight has received FDA 510(k) clearance for its i:X handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, which was granted 14 August 2018. A press release reports that [...]
E-nside CryoLife has received two CE marks, with one for the E-nside thoracoabdominal aortic aneurysm stent graft and one for the E-nya thoracic stent graft system. Two press releases announcing the CE marks, respectively, report that E-nside is the company's newest proprietary endovascular stent graft for patients with thoracoabdominal aortic disease and [...]
EOSedge EOS imaging has received 510(k) clearance from the FDA for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the recent commercial launch of EOSedge in Europe, Canada and Australia. A press release reports that EOSedge is the first general X-ray system powered by a high-resolution photon counting [...]
i-FACTOR The FDA has granted Cerapedics a premarket approval (PMA) supplement for its i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from patients enrolled in the [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 18 October to Friday 22 November) features FDA approval for IN.PACT AV, a recall for a guidesheath, and FDA Breakthrough Device Designation for [...]
Wrapsody Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that the Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins [...]
EchoGo Ultromics has received 510(K) clearance from the FDA for its image analysis system, EchoGo Core. According to a press release, the clearance is a major milestone for Ultromics and enables the business to make EchoGo available to clinicians and healthcare providers in the USA. EchoGo applies artificial intelligence (AI) to automate [...]
IN.PACT AV Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon [...]
Life Spine has received clearance from the FDA to market the Longbow titanium lateral expandable spacer system. A press release reports that system is available in lengths ranging from 45mm to 60mm, heights from 9mm to 15mm, 0 degrees and 7 degrees lordotic options and widths that expand from 15mm to 27mm anterior to [...]
Revivent TC The FDA has granted Breakthrough Device Designation status for its Revivent TC transcatheter ventricular enhancement system (BioVentrix) for heart failure. A press release reports that the less invasive ventricular enhancement (LIVE) procedures uses Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a myocardial [...]
Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a [...]
Paige has received the CE mark for Paige Prostate, which a press release reports is a first-in-class prostate cancer detection solution. Along with Paige Insight, an artificial intelligence (AI) native digital pathology viewer, Paige Prostate is designed for primary diagnosis. The press release states that these solutions are vendor neutral and allow for seamless [...]
Shockwave Lithotripsy Shockwave Medical has announced that it has initiated the DISRUPT CAD IV study of is intravascular lithotripsy (IVL) system for the management of in heavily calcified coronary arteries, with the intention of using data from the study to supporting regulatory device approval in Japan. Shigeru Saito (Shonan Kamakura General Hospital, [...]
Senza Omnia Nevro has received approval from the FDA for the Senza Omnia spinal cord stimulation (SCS) system. A press release reports that the Omnia system is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy in addition to all other available SCS frequencies. The Omnia system is [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 28 October to Friday 1 November) features a CE mark approval for Vascade MVP (Cardiva Medical), FDA Breakthrough Device Designation for Surmodics' Sundance [...]
Harel Gadot XACT Robotics has announced that its first robotic system was cleared to market in the USA for use during computed tomography (CT) guided percutaneous interventional procedures. A press release states that XACT’s technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various [...]
Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices. The Sundance SCB has been [...]
The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is [...]
Medtronic has received Breakthrough Device Designation from the FDA for a novel implantable left ventricular assist device (LVAD) for patients with advanced heart failure. A press release reports that, rather than the current LVAD systems that require a driveline cable that extends outside the body to a controller, the future system is designed to [...]
Valiant Navion Medtronic has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Valiant Navion thoracic endovascular aortic repair (TEVAR) system. Consequently, the company has launched the system in Japan for minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections. According [...]
Optimizer Smart Impulse Dynamics, developer of the Optimizer Smart system for delivering cardiac contractility modulation (CCM) therapy, has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart system for the treatment of heart failure. According to a press release, the Optimizer Smart system offers a new therapy [...]
One Click MRI HeartVista has received 510(k) clearance from the FDA for its artificial intelligence (AI) assisted One Click MRI acquisition software for cardiac exams. A press release reports that with HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent. It adds that, prior to the HeartVista system, the [...]
Vascade MVP Cardiva Medical has received the CE mark for its Vascade MVP venous vascular closure system. Additionally, the AMBULATE study has been published in JACC: Clinical Electrophysiology. According to a press release, the AMBULATE study demonstrates the safety and efficacy of the system compared with manual compression. The press release adds [...]
MagicTouch AVF Concept Medical has received the CE mark for its MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) catheter, making the catheter the first commercially available sirolimus device for peripheral arterial disease. The MagicTouch catheter has also been approved for treating erectile dysfunction (MagicTouch ED) and for managing arteriovenous fistula complications (MagicTouch AVF). [...]
The FDA has issued a new safety communication about Type III endoleaks with AFX endovascular grafts (Endologix). According to the safety communication, there may be a higher risk of Type III endoleaks with the use of AFX with Duraply and with AFX2. The FDA reports that this communication is based on a review of [...]
CE mark—TrelliX embolic coil system (Shape Memory Medical) Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial [...]
CorFlow Therapeutics has been granted Breakthrough Device designation from the FDA for its CorFlow Controlled Flow Infusion (CoFITM) system. According to a press release, the device is included in the Breakthrough Designation programme with the indication for use statement: “The CoFITM System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), [...]
Restore (Cardionovum), a paclitaxel-coated coronary balloon, now has Chinese market approval for in-stent restenosis and small vessel disease. The approval was given based on the results from two clinical studies in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA. RESTORE ISR CHINA and RESTORE SVD CHINA were both multicentre, randomised controlled trials. RESTORE [...]
Infuse The US Food and Drug Administration (FDA) has approved a new prospective, randomised clinical trial evaluating the use of recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse, Medtronic) during transforaminal lumbar interbody fusion (TLIF) procedures. The study is part of Medtronic’s long-term global clinical trial programme (BONE) evaluating the safety and efficacy [...]
Perflow Medical has received CE mark approval for the Cascade Agile non-occlusive remodelling net (Cascade Agile). Expanding the Cascade product family, a press release reports, the Cascade Agile optimises control for distal and tortuous vessel anatomy during coil embolisation of intracranial aneurysms. The Cascade Agile is the latest addition to Perflow’s portfolio of novel [...]
TrelliX Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial aneurysms, other neurovascular abnormalities such [...]
Canon Medical has received 510(k) clearance on its advanced intelligent Clear-IQ engine (AiCE) for the Aquilion Precision, which further expands access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE/GENESIS Edition premium computed tomography (CT) systems, uses a deep learning [...]
Source: BIBA MedTech Aortic Segmentation Monitor The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Medtronic for its novel Valiant thoracoabdominal aneurysm (TAAA) stent graft. A press release reports that the device is designed to offer an off-the-shelf solution for complex endovascular aneurysm repair (EVAR) procedures, adding that [...]
FDA 510 (k) clearance—FluoroShield (Omega Medical) Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a [...]
Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended [...]
Stellarex 0.035 Philips has added two new balloons to its portfolio of Stellarex 0.035 low-dose drug-coated balloons, following approval from the FDA. The new 200mm and 150mm Stellarex 0.035 low-dose balloons are now approved and available, in the USA, for the treatment of de novo and restenotic lesions in native superficial femoral [...]
Helix BioCardia has announced the renewal of the CE mark for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter—both are used in the delivery of biotherapeutics to the heart. A press release reports that the CE mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside [...]
IASD Corvia Medical has received FDA Breakthrough Device Designation for its Interatrial Shunt Device (IASD) for heart failure. A press release reports that the IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. It is designed to provide continuous and dynamic decompression of [...]
The FDA has approved a device (geko, Sky Medical Technology) for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. A press release reports that this adds to Sky’s established 510k clearance for immediate post-surgical stimulation of calf muscles to prevent venous thromboembolism, increasing blood circulation [...]
Torus stent graft PQ Bypass has received full approval of its investigational device exemption (IDE) trial (TORUS 2) of its Torus stent graft, which is a novel stent graft platform designed for the treatment of peripheral arterial disease in the superficial femoral artery. By acquiring early FDA feedback through the presubmission process, [...]
Medtronic is recalling its 6Fr Sherpa NX Active Guide Catheter because of a risk of the outer material separating from the device resulting in detached fragments, which could result in the underlying stainless-steel braid wires being exposed. The FDA, in a statement, has deemed this to be a “Class I recall”. According to the [...]
Cardioform ASD Occluder The Gore Cardioform ASD Occluder has received the CE mark. A press release reports that the device offers physicians a clinically proven design in a device that, in a recent study, met its primary endpoint for the percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). It adds that [...]
Intersim Medtronic has filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and faecal incontinence. The [...]
FDA approval—Proclaim XR (Abbott) Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. A press [...]
Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The Impella 5.5 with SmartAssist system is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic [...]
Proclaim XTR Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. The press [...]
The FDA has cleared three modules of AI-Rad Companion Chest CT, a software assistant from Siemens Healthineers that is designed to bring artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT helps radiologists interpret images of the thorax quickly with desired [...]
Intrepid Medtronic has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve implantation (TMVI) system using a minimally-invasive transfemoral access approach. A press release reports that this announcement builds upon primary endpoint outcomes of the Intrepid TMVI clinical trial (APOLLO), which showed that TMVI (via the [...]
MedAlliance has been awarded FDA Breakthrough Device Designation for the Selution SLR, which is a sustained limus release drug-eluting balloon catheter for the treatment of below-the-knee disease. According to a press release, the company was the first drug-eluting balloon company in the world to receive FDA Breakthrough Device Designation status for the treatment of [...]
Cardiovascular Systems (CSI) has announced FDA PMA approval of its ViperWire Advance coronary guidewire with Flex Tip (ViperWire Advance with Flex Tip). A press release reports that the ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360 orbital atherectomy system. It adds that the new guidewire offers a combination [...]
Evolut PRO+ The FDA has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for [...]
CE mark— Masters HP 15mm and Amplatzer Piccolo Occluder (both Abbott) Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other [...]
Wallaby Medical has announced CE mark approval and FDA 510(k) clearance of its differentiated embolic coil system—the Avenir coil system. The intended use for the Avenir coil system is for endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Avenir coil system is also intended for [...]
pDVA LimFlow has received FDA approval for its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow percutaneous deep vein arterialisation (pDVA) system. PROMISE II is a multicentre, prospective, single-arm study to be conducted in the USA and Japan. Using an adaptive statistical design, the study plans to [...]
EBR Systems has announced that the FDA has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and [...]
Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system. Class III medical devices represent the highest risk class of medical devices according to the [...]
Active Implants has announced that the NUsurface Meniscus implant has been granted a Breakthrough Device Designation from the FDA. A press release reports that the NUsurface Meniscus implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the USA. The [...]
Piccolo Occluder Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other suitable treatment option may exist”. The press [...]
Dapagliflozin (Farixga) The FDA has granted Fast Track designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDA’s Fast Track programme is designed to [...]
FDA approval—r-SNM system (Axonics) Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. [...]
ACR (Healthy.io) Healthy.io has received 510(k) clearance from the FDA for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease. A press release reports that this is the second FDA clearance the company has received. Additionally, the company also closed a $60 million Series C funding [...]
ARTIS Icono biplane The FDA has cleared the ARTIS icono (Siemens Healtineers)—a high-precision family of angiography systems that are designed to permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal use in neuroradiology and abdominal imaging, [...]
V-Wave has announced that the FDA has granted it a second Breakthrough Device Designation—the first was for its interatrial shunt for heart failure and the second is for pulmonary arterial hypertension. The company is testing a minimally invasive, implanted interatrial shunt device for pulmonary artery hypertension in a global approved investigational device exemption (IDE) [...]
Checkpoint BEST Checkpoint Surgical has received FDA Breakthrough Device Designation for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST system is, a press release reports, designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury, with the goal of [...]
Critical Care Suite GE Healthcare has received FDA 510(k) clearance of its Critical Care Suite, which a press release reports are an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms are [...]
r-SNM Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. The [...]
CE mark approval—Moderato implantable pulse generator system (Orchestra BioMed) Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II [...]
Bardy Diagnostics has received 510(k) clearance from the FDA for a 14-day version of the Carnation Ambulatory Monitor (CAM), which a press release says is market’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will [...]
BackBeat CNT Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat [...]
Shockwave Lithotripsy Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. A press release reports that the Shockwave C2 IVL catheter is [...]
MagicTouch AVF Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure. The proposed indications for the MagicTouch AVF devices are for it to be used, [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 26 August to Friday 30 August. FDA approval—MID-C (ApiFix) ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the [...]
Biobeat’s smartwatch and patch. The FDA has granted a 510K clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. According to press release, Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway. [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 19 August to Friday 23 August. FDA Class I recall—delivery system of Sapien 3 Ultra The FDA has issued a Class I recall—which [...]
DiscGenics has announced that the FDA has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the USA and Japan for the reduction in pain and disability associated with degenerative disc disease. A press release reports that IDCT is reproducibly manufactured in a cGMP environment [...]
Miracor Medical has been granted Breakthrough Device Designation by the FDA for its PiCSO Impulse System for treatment of ST-segment elevation myocardial infarction (STEMI) patients. The PiCSO impulse system is designed to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. [...]
The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 12 August to Friday 16 August. Cardiology FDA approval—Evolut R, Evolut PRO (Medtronic); Sapien 3, Sapien 3 Ultra (Edwards Lifesciences) The FDA has [...]
The FDA has approved the Barostim Neo system (CVRx) for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy. A press release reports that, previously, the FDA gave the device a Breakthrough Device designation because it treats [...]
AMDS delivery system Ascyrus Medical has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. A press release reports that this designation serves as validation of the clinical importance of the AMDS and represents a significant milestone in the continued [...]
V-Wave has announced that the FDA has just granted the company a Breakthrough Device Designation for its interatrial shunt for heart failure. V-Wave’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomised, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved [...]
The Tether Zimmer Biomet has announced FDA approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. A press release reports that The Tether uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten [...]
Vercise Gevia Boston Scientific has announced the FDA approval of its ImageReady MRI labelling for the Vercise Gevia deep brain stimulation (DBS) system to be used in a full-body magnetic resonance imaging (MRI) environment. This system, with the Vercise Cartesia directional lead, is designed to treat the symptoms of Parkinson’s disease by [...]
Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease [...]