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.

SAN FRANCISCO – The accelerating confluence of information technology and medical devices is transforming the latter into a true embodiment of med tech. That was the conclusion of early keynote sessions at the Transcatheter Cardiovascular Therapeutics (TCT) that began here yesterday.

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.

BEIJING – China has cleared for marketing the country's first domestically developed artificial heart, according to Chongqing, Sichuan province-based regulators. Evaheart I was developed by Chongqing Evaheart Medical Device Co. Ltd.

Croívalve, a Dublin-based startup supported by Enterprise Ireland that is developing a treatment for tricuspid regurgitation (TR), recently secured €4 million (US$4.4 million) in additional financing. The financing includes €2.5 million from the EU's Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors Halo Business Angel Network Medtech and Irrus Syndicates, Atlantic Bridge University Fund and Sos Ventures. The funding will accelerate the development of the company's technology into first-in-human (FIH) studies.