W. L. Gore & Associates received expanded FDA approval, broadening the use of its balloon-expandable stent graft and opening it up for the treatment of complex aortic aneurysms. The Viabahn VBX endoprosthesis was greenlit for use in both fenestrated and branched endovascular aortic repairs, known as FEVAR and BEVAR, where an aneurysm develops too close […]
Structural Heart
Edwards earns FDA approval for first-of-its-kind size-adjustable pediatric heart valve
Edwards Lifesciences earned FDA approval for its Autus size-adjustable heart valve, a surgical pulmonary heart valve for pediatric patients with congenital heart disease, the company announced today. The first-of-its-kind valve is designed to expand as the child grows, reducing the need for repeat open-heart surgeries. It’s also the first artificial heart valve approved in the […]
Mitria Medical teams with Silicon Valley incubator for mitral repair device
Mitria Medical is joining up with the Silicon Valley medtech incubator T45 Labs and bringing on a new CEO as it looks to develop its minimally invasive implant for repairing the heart’s mitral valve. The startup announced earlier this year the first implantation of its transcatheter subvalvular spacer, or SVS, delivered under the FDA’s compassionate […]
Intuitive receives CE mark for da Vinci 5 cardiac procedures
Intuitive (NASDAQ: ISRG) continues to get back to its roots, claiming a European approval for its da Vinci 5 system in minimally invasive cardiac procedures. After first being founded to chase robotic heart surgery — before a decades-long pivot into high-volume gynecologic, urologic and general procedures — Intuitive recently re-entered the space by picking up […]
UltraSight raises $24M in Series B2 to scale AI-guided cardiac ultrasound technology
AI-guided cardiac technology developer UltraSight has raised $24 million in Series B2 financing, the company announced. The financing will support the company’s commercial expansion in the United States and the development of new software systems for intensive care and circulatory support settings, UltraSight said. Alive HealthTech Grow Fund led the round with an undisclosed investment. […]
Corcym delivers first-in-human implant of Memo 4D Curve mitral repair ring
After completing a first-in-human implantation of its tricuspid system earlier this month, Corcym has announced another first placement designed for the heart’s mitral valve. The Memo 4D Curve broadens the company’s Memo surgical mitral repair platform, adding an open-ring configuration with a semi-rigid annuloplasty implant featuring a laser-cut nitinol cell structure. The device received FDA […]
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary in-stent restenosis.” Cordis President of Americas […]
Citi downgrades Boston Scientific as cyberattack recovery compounds competitive pressure
Analysts at Citigroup bowed to the uncertainty surrounding Boston Scientific’s (NYSE:BSX) immediate financial future, delivering a downgrade to its stock rating as headwinds in its cardiac business are complicated by its recovery from a major cyberattack last month. Citi’s researchers have lowered their estimates for the company eight times so far this year, most recently […]
Johnson & Johnson drops LAA assets following suspended pivotal study
Johnson & Johnson MedTech (NYSE:JNJ) is offloading a left-atrial appendage closure system it paid $400 million upfront for nearly three years ago, abandoning plans to compete in the space dominated by Boston Scientific and Abbott. Acquired through its late-2023 buy of the developer Laminar, J&J’s Biosense Webster then backed a pivotal study that sought to […]
Johnson & Johnson’s Abiomed recalls Automated Impella Controllers after 3 patient deaths
Johnson & Johnson’s Abiomed recommends customers remove all Automated Impella Controllers (AICs) from where they’re used or sold after 37 reports of serious injuries and three deaths were linked to component failures. Abiomed identified purge cassette recognition issues “resulting from failures of the purge flag component within the purge pressure sensor assembly.” J&J issued the […]
Abbott’s next-generation Amulet LAA occlusion device earns CE Mark
Abbott’s (NYSE: ABT) Amulet 360 left atrial appendage (LAA) occlusion device received CE mark, the company announced today. The next-generation minimally invasive device is designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AFib) by helping seal the LAA of the patient’s heart. Amulet 360 features a redesigned dual-seal technology that […]
