Medtronic today announced the launch of its next-generation Avalus Ultra surgical aortic tissue valve. The medtech giant designed the valve to facilitate ease of use at implant and lifetime patient management. It offers clear visibility for future valve-in-valve procedures and straightforward sizing. Other features of Avalus Ultra include a low profile and a polyetheretherketone (PEEK) […]
Replacement Heart Valves
CroíValve is set to challenge as tricuspid regurgitation treatment space heats up
With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
Caranx performs first TAVI procedure using surgical robot
Caranx Medical today announced it completed its first robotic assisted transcatheter aortic valve implantation. The assisted heart valve implantation in an animal was successfully performed by Dr. Stéphane Lopez, Caranx CMO Dr. Eric Sejor, Caranx CTO Pierre Berthet-Rayne and the Caranx team. “This groundbreaking achievement is the result of hard teamwork. At Caranx Medical, we […]
Medtronic survey reveals barriers to women’s heart health care
A Medtronic survey recently revealed a lack of awareness among women regarding heart valve disease and the risk factors. The survey examined women’s perceptions and knowledge of risk factors, treatment patterns, and preventative care practices related to heart valve disease. It was endorsed by Women as One and conducted by Wakefield Research, which sampled 1,000 […]
Medtronic says Evolut TAVR outperformed Edwards Sapien in head-to-head trial
Medtronic today announced data from a head-to-head trial backing its Evolut TAVR system against the Edwards Sapien platform. The medtech giant presented results from the one-year SMART trial at the American College of Cardiology Annual Scientific Session. It simultaneously published the study results in The New England Journal of Medicine. SMART evaluated Evolut and Sapien […]
JenaValve publishes positive data for its TAVR system
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 […]
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, […]
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 […]