Device durability for transcatheter aortic valve replacement (TAVR) devices remains topical for patients, payers and regulators, but the standard measure of 10-year data were difficult to obtain for the first decade after the FDA first approved a TAVR device in 2011.
The patent wars over the design of transcatheter aortic valve replacement (TAVR) devices seemed to disappear roughly nine years ago, but there is at least one more episode for Dublin-based Medtronic plc before the company could lay the issue to rest. A jury declared that Medtronic is liable for more than $100 million in damages over alleged infringement of a patent held by Broomfield, Colo.-based Colibri Heart Valve LLC, but the contested patent has expired, and Medtronic said it intends to pursue the matter further.
Truleaf Medical Ltd., a subsidiary of Israel-based Allmed Solutions, is ready to begin human trials of its Rosedoc platform to replace the heart’s leaky mitral valve using cardiac catheterization.
Structural heart startup Nyra Medical Inc. scooped up $20 million in a series A round co-led by Vensana Capital and a large, unnamed global medical device company. The funds will be used to advance Nyra’s transcatheter heart valve repair technology through early feasibility clinical studies.
Results from the largest trial yet in transcatheter valve replacement continues to demonstrate strong results for Edwards Lifesciences Corp.’s Evoque system. A late-breaking presentation at the PCR London Valves 2022 meeting provided one-year follow-up results from the Triscend study showing better than 90% survival and 99% freedom from heart failure hospitalization. Further, 97.6% of patients maintained mild or trace tricuspid regurgitation.
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
One of the biggest stories coming out of Transcatheter Cardiovascular Therapeutics’ annual meeting in Boston this weekend focuses on the success of Edwards Lifesciences Corp.’s freshly FDA-approved Pascal Precision transcatheter valve repair system in the CLASP IID trial, which compared it to Abbott Laboratories’ Mitraclip device in patients with degenerative mitral regurgitation (DMR) who were determined to be at prohibitive surgical risk.
Although it was recently overturned in a legal challenge, a short-lived California state law mandating gender quotas for corporate boards may have made a few drug and device companies based in the state think twice about the makeup of their boards.
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
