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 […]
Replacement Heart Valves
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 […]
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 […]
Medtronic has positive Evolut TAVR data
Medtronic today reported two different datasets that support its Evolut transcatheter aortic valve replacement (TAVR) system. A cost-effectiveness analysis demonstrated the positive economic value of TAVR using Evolut in low-risk patients. It compared Evolut to surgical aortic valve replacement (SAVR). Then, Medtronic had contemporary data from its Evolut low-risk trial reinforcing long-term TAVR outcomes compared […]
Affluent Medical has positive biomimetic mitral valve data
Affluent Medical today announced positive findings in a clinical evaluation of its Epygon device for replacing mitral valves. The Aix-en-Provence, France-based company designed Epygon to replace mitral valves in those with mitral insufficiency. Epygon is the first biomimetic transcatheter mitral valve to mimic the native mitral valve and restore the natural vortex of blood flow […]
BiVacor raises $13M to support artificial heart trial
BiVacor announced today that it brought in $13 million from the Australian government to support its Total Artificial Heart program. Australia’s Medical Research Future Fund (MRFF) provided a grant through its Artificial Heart Frontiers Program (AHFP). It aims to support the company’s TAH program and future product enhancements. BiVacor received FDA investigational device exemption to […]
TAVR, Critical Care drive Edwards to Q4 sales beat
Edwards Lifesciences shares dipped slightly today on fourth-quarter results that topped the consensus sales forecast. Shares of EW fell 0.2% to $88.11 in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.3%. The Irvine, California-based company posted profits of $369.9 million. That equals […]
Genesis MedTech completes enrollment in TAVR trial
Genesis MedTech announced today that it completed enrollment in its U.S. early feasibility study for its J-Valve transfemoral TAVR system. Developed by JC Medical, the U.S.-based Genesis subsidiary, J-Valve holds FDA breakthrough device designation. Its breakthrough designation covers the treatment of severe native aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. Patients eligible for […]
Edwards wins FDA approval for its Evoque replacement tricuspid valve
Edwards Lifesciences announced today that the FDA granted approval for its Evoque tricuspid valve replacement system. The company says this makes Evoque the first transcatheter therapy to receive an FDA nod to treat tricuspid regurgitation (TR). Irvine, California-based Edwards won CE mark for the Evoque system in October 2023. That approval also marked a first […]
CroíValve wins FDA IDE for tricuspid heart valve
CroíValve announced today that it began an early feasibility study for its Duo tricuspid coaptation valve system. The beginning of the study follows FDA investigational device (IDE) approval. Tandem II, a prospective, multi-center, non-randomized, single-arm study looks at the safety and performance of Duo in patients with severe or greater symptomatic tricuspid regurgitation (TR). Duo […]