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.

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.

The FDA has granted breakthrough device designation to Sonivie Ltd.'s Therapeutic Intra-Vascular Ultrasound (TIVUS) system for the treatment of pulmonary arterial hypertension (PAH). Early clinical studies suggest that the catheter-based system could stabilize or reduce pressure in the pulmonary vasculature of PAH patients, a population with an average survival rate of five years.