Haemonetics (NYSE:HAE) announced today that it received FDA approval to expand the labeling for its Vascade MVP XL system. Expanded labeling includes procedures using 10-14F inner diameter (ID) and up to 17F outer diameter (OD) procedural sheaths. This grants Vascade MVP XL approval for larger sheaths used in market-leading technologies used for … [Read more...] about Haemonetics wins expanded FDA nod for vascular closure system in PFA, LAAC to treat AFib
Cardiac Implants
Valcare announces first transseptal implantation of Amend annuloplasty system in U.S.
Valcare Medical announced the first successful U.S. transseptal implantation of its Amend transcatheter mitral valve repair annuloplasty system. The milestone implantation was a part of an ongoing early feasibility study, according to the company’s statement released today. “Annuloplasty has served as the foundation of more than 95% of surgical … [Read more...] about Valcare announces first transseptal implantation of Amend annuloplasty system in U.S.
The biggest cardiac tech news out of the 2026 AF Symposium
Last week, the leading developers of treatments for atrial fibrillation (AFib) convened in Boston for the 2026 AF Symposium. At the event, the makers of technologies like pulsed field ablation (PFA) systems, left atrial appendage (LAA) devices, heart access catheters and more offered insights into how their therapies contribute to the treatment … [Read more...] about The biggest cardiac tech news out of the 2026 AF Symposium
Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Edwards Lifesciences [WtwhTicker symbol="EW"](NYSE: EW)[/WtwhTicker] has won FDA approval for its Sapien M3 mitral valve replacement system for treating mitral regurgitation (MR). The company said it's the first approval for a transcatheter MR therapy utilizing a transseptal approach. The approval came earlier than Edwards expected. The … [Read more...] about Edwards wins FDA approval for Sapien M3 mitral valve, marking first transseptal transcatheter therapy
Abbott wins FDA clearance, CE mark for Amplatzer Piccolo delivery system
Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] announced today that it received FDA clearance for its Amplatzer Piccolo delivery system for use with the Amplatzer Piccolo Occluder. Additionally, the system picked up CE mark for commercialization in Europe. The company designed its new delivery system specifically to treat premature … [Read more...] about Abbott wins FDA clearance, CE mark for Amplatzer Piccolo delivery system
Procyrion adds former Silk Road Medical exec as new CCO
Procyrion announced today that it appointed Andrew Davis as its new chief commercial officer (CCO), effective immediately. Houston-based Procyrion develops a catheter-deployed percutaneous mechanical circulatory support (pMCS) device called Aortix. The company designed the device to treat patients with acute decompensated heart failure (ADHF) … [Read more...] about Procyrion adds former Silk Road Medical exec as new CCO
VenstraMedical picks up investment for ventricular assist device
VenstraMedical announced today that it secured an investment to accelerate the development of its percutaneous ventricular assist device (pVAD). Highcroft Capital, a Minnesota-based venture capital firm specializing in medtech innovation, delivered the undisclosed investment. It supports the Newcastle, Australia-based company’s low-profile, … [Read more...] about VenstraMedical picks up investment for ventricular assist device
Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal
Boston Scientific [WtwhTicker symbol="BSX"](NYSE: BSX)[/WtwhTicker] today announced a catheter development and commercialization deal with Siemens Healthineers. The deal centers around the workflow development and commercialization of Siemens Healthineers' AcuNav 4D intracardiac echocardiography (ICE) catheter. AcuNav 4D ICE technology is … [Read more...] about Boston Scientific, Siemens Healthineers ink 4D ICE catheter development deal
Boston Scientific reports strong Farapulse, Watchman FLX data
Boston Scientific (NYSE: BSX) today shared positive findings from studies for its Farapulse and Watchman FLX offerings. Farapulse, a pulsed field ablation (PFA) system, provides an option to treat AFib. It received FDA approval in early 2024 and this summer picked up expanded approval. Watchman FLX, Boston Scientific's left atrial appendage … [Read more...] about Boston Scientific reports strong Farapulse, Watchman FLX data
Boston Scientific has a serious recall for carotid WallStent monorail endoprosthesis
The FDA issued a notice outlining a serious recall of the Boston Scientific carotid WallStent monorail endoprosthesis. According to the FDA, the device may cause serious injury or death with continued use, making it the most serious type of recall. Boston Scientific instructed users to immediately stop using affected devices and remove them from … [Read more...] about Boston Scientific has a serious recall for carotid WallStent monorail endoprosthesis
