JenaValve announced today that it published new results supporting the use of its transcatheter aortic valve replacement (TAVR) system. The company published results from its ALIGN-AR pivotal trial in The Lancet. The trial evaluates the Trilogy valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. JenaValve presented positive study results from ALIGN-AR last […]
Cardiac Implants
FDA approves next-gen Evolut TAVR system from Medtronic
Medtronic announced today that the FDA approved its next-generation Evolut FX+ transcatheter aortic valve replacement (TAVR) system. The FDA’s approval covers the treatment of symptomatic aortic stenosis. Medtronic says the latest version of the Evolut valve maintains the performance of the Evolut platform with a design that facilitates coronary access. Evolut FX+ TAVR offers larger […]
Protembis raises $32.6M, adds Shockwave exec to board
Cardiovascular medical device maker Protembis announced today that it completed a $32.6 million (€30 million) Series B financing round. The Aachen, Germany-based company plans to use the funds to support enrollment for its PROTEMBO FDA investigational device exemption (IDE) trial. The trial evaluates the company’s embolic protection technology. European VC investors, including Segulah Medical Acceleration, […]
Abbott wins CE mark for insertable cardiac monitor
Abbott announced today that it received CE mark approval for its Assert-IQ insertable cardiac monitor (ICM). The ICM provides a new option for diagnostic evaluation and long-term monitoring in people experiencing abnormal heartbeats. It can detect hard-to-spot irregularities in heartbeats and help physicians determine the best treatment course. Assert-IQ received FDA clearance in May 2023, […]
J&J’s Abiomed has a Class I Impella labeling recall with 49 deaths related to issue
The FDA deemed a recall of heart pumps from Johnson & Johnson MedTech’s (NYSE:JNJ) Abiomed Class I, the most serious kind. Abiomed reports 129 serious injuries, including 49 deaths, related to the issue of potential cuts in the wall of the heart. This recall (a correction and not a product removal) affects 66,390 Impella pumps […]
Conformal Medical reports ‘encouraging’ results for left atrial appendage occlusion device
Conformal Medical announced “encouraging” results when comparing its CLAAS implant to the Boston Scientific Watchman FLX. These left atrial appendage occlusion (LAAO) devices bring different things to the table. Made of foam, CLAAS features a cup design with an embedded nitinol skeleton covered by a fluoropolymer (ePTFE) cover. Watchman FLX’s nitinol frame is covered by […]
Edwards reports ‘excellent’ outcomes with Sapien TAVR
Edwards Lifesciences announced positive results from two real-world studies evaluating its Sapien transcatheter aortic valve replacement (TAVR) system. Results came from the TVT Registry data and continued to demonstrate strong outcomes. Edwards presented the data at Cardiovascular Research Technologies (CRT) 2024. A study of the latest TAVR technology, the Sapien 3 Ultra Resilia valve found […]
Abbott is launching its latest Navitor TAVI system in the U.S.
Abbott is launching the latest generation of its Navitor heart valve technology in the U.S., according to one company official. In a post on LinkedIn, Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), shared the news of the launch. The latest version — called the Navitor Vision — features a range of […]
SS Innovations uses surgical robot in mitral valve replacement
SS Innovations announced today that surgeons successfully performed a mitral valve replacement using its surgical robot. The procedure marks the world’s first mitral valve replacement using the company’s Mantra surgical robot. It took place at the Narayana Hrudayalaya Institute of Cardiac Sciences in Bengaluru, India. Dr. Nitin Kumar Rajput performed the surgery, guided by Dr. Sudhir […]
Recall of Abbott HeartMate comms system is Class I
The FDA deemed a recall of the Abbott HeartMate Touch Communication System Class I, the most serious kind of recall. Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero […]
Abbott reports data that backs TAVR, LAA systems
Abbott today reported positive study data supporting its first-generation transcatheter aortic valve system and its Amplatzer Amulet. Abbott reported its outcomes at the Cardiovascular Research Technologies (CRT) 2024 meeting. The company first reported a pooled analysis from three clinical studies evaluating its Portico TAVR system, the predecessor to Navitor. It showed the safety and effectiveness […]