SAN FRANCISCO – As the transcatheter aortic valve replacement (TAVR) field matures, it is becoming increasingly difficult to develop a new implant that can distinguish itself vs. competitors. The incremental benefits are narrowing rapidly, making it tough to distinguish new iterations from one another using standard, randomized trials.
SAN FRANCISCO – Mitraclip from Abbott Park, Ill.-based Abbott Laboratories, has long been the only minimally invasive mitral valve repair device that's approved by the FDA. Edwards Lifesciences Corp., of Irvine, Calif., aims to challenge that dominance with its Pascal. This week at the Transcatheter Cardiovascular Therapeutics (TCT) conference, positive one-year data from the small CLASP study on Pascal were presented, offering a further glimpse of data for comparison.
Corvia Medical Inc. is enrolling patients in a 100-site multinational study of its Interatrial Shunt Device that will measure traditional heart failure endpoints as well as biosensor data transmitted to the cloud for analysis by Napier, Ill.-based Physiq's artificial intelligence analytics. The trial will evaluate Tewksbury, Mass.-based Corvia's device in heart failure with preserved and mid-range ejection fraction.