At its investor day conference, Edwards Lifesciences Corp. prognosticated that an expanded indication in transcatheter aortic valve replacement and rapid growth in its newer mitral and tricuspid heart valve technologies will accelerate total company sales in 2026 and beyond.
Edwards Lifesciences Corp. received some good news with the earlier-than-expected U.S. FDA approval of its Evoque tricuspid valve replacement system. The company beat out rival Abbott Laboratories for the honor of being the first transcatheter therapy to receive FDA approval.
One-year results from the CLASP IID trial and registry showed outstanding results in patients with significant symptomatic degenerative mitral regurgitation (DMR) for Pascal, Edwards Lifesciences Corp.’s transcatheter-edge-to-edge repair (TEER) system, in a presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) meeting in San Francisco hosted by the Cardiovascular Research Foundation.
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
The tricuspid valve at times seems the lost child of the heart’s valves, but new research hints that regurgitation of this valve can be resolved with a transcatheter replacement. Adam Greenbaum, of Emory University School of Medicine, said the early feasibility study of the Pascal valve by Edwards Lifesciences Inc., of Irvine, Calif., demonstrated a large improvement in mortality at one year and significant improvements in heart failure status, a result that offers new hope for these patients.
Edwards Lifesciences Corp. reported good news this week, with its third-quarter results exceeding expectations. Sales came in at $1.1 billion, an increase of 4%, and CEO Mike Mussallem highlighted the success of transcatheter aortic valve replacement (TAVR), with the Sapien valve platform performing well. Mussallem noted that TAVR sales were $745 million, up 6%, with Europe showing strength.
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.
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.
Minimally invasive structural heart implants are moving from mitral into tricuspid valve repair, as well as mitral valve replacement. Abbott Laboratories is presenting its latest data on all these fronts at the virtual PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions from June 25 to 27.
