Edwards Lifesciences Corp. reported better-than-expected results when it released its second quarter earnings late July 23, with revenue down 15% to $924 million, from $1.1 billion in the same period of 2019. The results beat Wall Street consensus of $797.5 million, and reflected an uptick in surgical procedures that had been delayed by the COVID-19 pandemic. The Irvine, Calif.-based company sustained a net loss of $121.9 million, or $0.20 per share, based on generally accepted accounting principles (GAAP), a sharp drop from $242.3 million, or $0.38 per share, in the same quarter last year. However, adjusted earnings looked brighter at $0.34 per share.

Edwards Lifesciences Corp. has scored an approval from the U.S. FDA for the Konect Resilia aortic valved conduit, a ready-to-implant solution for bio-Bentall procedures.

Ongoing litigation between rivals Edwards Lifesciences Corp. and Abbott Laboratories is over, with the two settling all outstanding patent disputes in cases related to transcatheter mitral and tricuspid repair products. Details of the settlement remain confidential.

The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.

Protaryx Medical has picked up $8.3 million to develop its device for precision transseptal access to the left atrium for use during structural heart and catheter ablation procedures. The funding includes nondilutive grants and a seed round totaling $3.2 million, as well as the recently closed $5.1 million series A financing led by Ajax Health, with participation from returning investor University of Maryland (UM) Ventures.

Medical science continues to define the relative risks of progressively smaller patient subsets across the disease spectrum, but this is particularly true of late in connection with aortic stenosis (AS).

Edwards Lifesciences Corp. has gained a CE mark for its Pascal transcatheter valve repair system to treat tricuspid regurgitation (TR). It was previously approved for mitral regurgitation treatment. Due to the pandemic, Edwards has paused new enrollments in its ongoing mitral and tricuspid pivotal clinical trials.

Physicians who perform a variety of device implant procedures face a difficult choice in determining whether a patient should be treated. A new article in the Journal of the American College of Cardiology (JACC) recommends that patients who ordinarily would be candidates for surgical aortic valve replacement (SAVR) might instead be referred for the transcatheter alternative.

Abbott Laboratories, of Abbott Park, Ill., reported that its Triclip transcatheter tricuspid valve repair system has received the CE mark. The device is a nonsurgical treatment for people with tricuspid regurgitation (TR), and, according to the company, it is the first minimally invasive, clip-based tricuspid valve repair device to be commercially available. The Triclip is delivered to the heart through the femoral vein in the leg and works by clipping together a portion of the leaflets of the tricuspid valve to reduce the backflow of blood.

Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.