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)
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.
CE mark—Gallant CRT-D (Abbott)
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.
CE mark—Osiro Mission (Biotronik)
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.
CE mark—Selution SLR (MedAlliance)
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.
CE mark—XableCath Crossing for peripheral use (XableCath)
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 devices last year.
FDA authorisations/approvals/de novo clearance
FDA authorisation—Caption Guidance software (Caption Health)
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.
FDA clearance—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.
FDA de novo clearance—Surfacer Inside-out (BlueGrass Vascular Technologies)
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 or other conditions that preclude central venous access by conventional methods.
FDA Breakthrough Device Designation/study expansion
FDA Breakthrough Device Designation—Aria CV PH System (Aria CV)
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
FDA Breakthrough Device Designation—Fully implantable left ventricular assist system (Abbott)
The 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” the development of the new system.
FDA Breakthrough Device Designation—tricuspid valve replacement system (Cardiovalve)
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.
FDA approve expanded enrolment of study—AccuCinch ventricular repair system (Ancora Heart)
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).
