Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated.

Edwards Lifesciences Corp. launched a pivotal trial of its mitral valve repair system in the U.S., with the first patient undergoing treatment for severe degenerative mitral valve regurgitation at the University of Maryland Medical Center in Baltimore. Open-heart surgery is the current standard approach to mitral valve repair, but the Harpoon Beating Heart mitral valve repair system allows surgeons to use a minimally invasive approach, according to Edwards Lifesciences.

Royal Philips NV is expanding its cardio footprint with the acquisition of Biotelemetry Inc., a manufacturer of remote medical technologies, for $2.8 billion, or $72 per share. The proposed deal, announced Friday, furthers Philips’ goal of providing integrated solutions across the care continuum, with Biotelemetry’s cardiac diagnostics and monitoring tools joining Philips’ line of hospital-based patient monitoring solutions. Philips expects the Biotelemetry business to contribute to sales growth and EBITA margin in 2021 and deliver double-digit growth and improve profit margins to more than 20% by 2025.

The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. Patient enrollment is expected to begin in early 2021.

Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.

PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS).

Edwards Lifesciences Corp. held its 2020 virtual investor conference Dec. 10, providing details on its 2021 financial outlook. The company is projecting global mid-teen sales growth totaling $4.9 billion to $5.3 billion and a return to double-digit sales growth in its transcatheter aortic valve replacement (TAVR) business. Earnings per share (EPS) guidance for the coming year is $2-2.20, below the consensus estimate of $2.21, due to investments in R&D and sales to fuel future growth.