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 […]
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FDA grants breakthrough nod for Pi-Cardia leaflet modification device for TAVR
Pi-Cardia announced today that the FDA granted breakthrough device designation for its ShortCut leaflet modification device. ShortCut facilitates valve-in-valve transcatheter aortic valve replacement (TAVR) procedures in patients at risk of coronary obstruction. Rehovot, Israel–based Pi-Carda earned the breakthrough nod after completing enrollment in a U.S. and European pivotal study last September. The leaflet modification system […]
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE […]
5-year data supports Edwards Lifesciences’ Sapien 3 TAVR
Edwards Lifesciences announced new data demonstrating continued positive outcomes with its Sapien 3 transcatheter aortic valve replacement (TAVR). Results from the PARTNER 3 trial showed continued low rates of all-cause mortality, disabling stroke and rehospitalization at five years. Edwards presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) in San Francisco. It simultaneously published […]
Medtronic Evolut TAVR outperforms surgical valve replacement in study
Medtronic today announced positive four-year results from a trial of its Evolut transcatheter aortic valve replacement (TAVR) system. Evolut TAVR demonstrated “exceptional outcomes and sustained valve performance,” Medtronic says. It showed significantly better hemodynamics than surgical aortic valve replacement (SAVR). The company presented the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) conference in San […]
Boston Scientific completes enrollment in next-gen aortic valve registry
Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment. The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across […]
J&J’s Abiomed recalls Impella again — this time it’s TAVR-related
Johnson & Johnson’s Abiomed unit issued another recall for some of its Impella heart pumps. FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from […]
Medtronic issues TAVR safety notice in Europe
Medtronic issued an urgent field safety notice for its replacement heart valve in Europe. The warning covers the Medtronic CoreValve Evolut Pro+ 34 mm transcatheter aortic valve replacement (TAVR). It’s dated December 2022, although it was published to a European regulatory site last week. Medtronic notified customers of a “known phenomenon” that occurs when the […]
Medtronic touts 3-year data for Evolut TAVR
Medtronic (NYSE:MDT) announced three-year data supporting its Evolut transcatheter aortic valve replacement (TAVR) system. Findings from the Evolut Low-Risk trial demonstrated numerically better clinical outcomes for the Evolut TAVR system. It also showed significantly better hemodynamic valve performance compared to surgical aortic valve replacement (SAVR). The study evaluated a low-risk aortic stenosis (AS) patient population. […]
Data backs durability of Medtronic CoreValve Evolut TAVR
Medtronic (NYSE:MDT) today announced five-year data that supports its CoreValve Evolut transcatheter aortic valve replacement (TAVR) implant. Dr. Steven Yakubov presented findings at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023). The data showed significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR). Medtronic’s study evaluated bioprosthetic valve dysfunction […]
Abbott wins FDA nod for its Navitor transcatheter aortic valve implant
Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system. The company designed the Navitor system for treating people with severe aortic stenosis at high or extreme risk for open-heart surgery. It adds to Abbott’s transcatheter structural heart portfolio of less invasive treatment options for serious heart […]