Edwards Lifesciences announced today that it received FDA approval for its Sapien 3 TAVR for severe aortic stenosis (AS) without symptoms. This marks the first FDA approval for transcatheter aortic valve replacement (TAVR) in asymptomatic AS patients. Approval came on the back of data from the EARLY TAVR trial. EARLY TAVR demonstrated that asymptomatic severe […]
Edwards Lifesciences
Edwards posts Street-beating Q1 results, ups 2025 sales guidance
Edwards Lifesciences shares are up today on Street-beating Q1 results and increased full-year sales guidance. EW shares were up more than 6% this morning to $75.05 apiece on the positive Q1 report that Edwards released after hours yesterday. (The S&P 500 was up slightly.) The Irvine, California–based heart valve technology leader reported profits of $358 […]
Edwards touts 8-year data for Resilia valve tissue
Edwards Lifesciences today announced eight-year data highlighting positive long-term outcomes with its proprietary Resilia tissue. Irvine, California–based Edwards — a leader in heart valve technology — designed its Resilia technology to extend valve durability. It utilizes bovine pericardial tissue treated with anti-calcification technology to serve as the platform for Edwards’ new class of valves. The […]
Edwards wins CE mark for Sapien M3
Edwards Lifesciences announced today that it received CE mark approval for its Sapien M3 mitral valve replacement system. Sapien M3 treats patients with symptomatic (moderate-to-severe or severe) mitral regurgitation (MR). Such patients are deemed unsuitable for surgery or transcatheter edge-to-edge (TEER) therapy. This makes Sapien M3 the first approved transcatheter valve replacement therapy using a […]
The biggest cardiology tech news out of ACC 2025
Chicago was the site for the latest edition of the American College of Cardiology (ACC) Scientific Sessions. There, a number of the biggest names in heart technology shared clinical findings highlighting the latest innovations in the space. Study data highlighted the benefits of technologies including replacement heart valves, monitors and more. Companies like Medtronic, Edwards, […]
Edwards shares data supporting timely TAVR intervention
Edwards Lifesciences today announced new data supporting its heart valve replacement technologies. Investigators shared findings from multiple studies at the American College of Cardiology’s (ACC) Annual Scientific Session & Expo in Chicago. Results from the EARLY TAVR trial — the first randomized, controlled FDA pivotal study designed to determine the best strategy for treating asymptomatic […]
Edwards stock rises on Street-beating Q4
Edwards Lifesciences shares got a boost on fourth-quarter results that came in ahead of the consensus forecast. Shares of EW were up more than 6% to $75.68 apiece by midday trading today, the day after the after-hours earnings report. The Irvine, California–based medtech company reported profits of $385.6 million. That equals 65¢ per share on […]
Analysts expect JenaValve TAVR approval for aortic regurgitation in 2025
GlobalData analysts anticipate FDA approval for the JenaValve Trilogy TAVR device designed to treat aortic regurgitation (AR) this year. In a report, GlobalData says it expects the FDA to approve the transcatheter aortic valve replacement (TAVR) device by late 2025. TAVR currently serves as an option to treat aortic stenosis (AS). Expanding its indications to […]
The top 10 cardiac device stories of 2024
Cardiac device innovations made waves in 2024, with regulatory approvals, clinical breakthroughs, and product launches driving advances in heart care. Medtech giants like Medtronic, Abbott, and Edwards Lifesciences captured the minds of MassDevice readers alongside news from tech giant Apple, which entered the spotlight with a landmark FDA approval. The most popular stories of 2024 […]
The top medtech stories of 2024
AFib-treating cardiac ablation, surgical robotics, nitinol and diabetes treatment tech lead among this year’s top medtech stories. Meanwhile, medical device companies have been seeking more tuck-in M&A — and continuing to refocus and boost operational efficiency — to better prepare for whatever the future brings. Here are the top medtech stories that caught the attention […]
The biggest medtech M&A moves of 2024
In 2024, we saw another proactive year for some of the biggest names in medtech as they looked to bolster their ranks through acquisitions. Over the course of the year, the number of billion-dollar sales deals continued to climb, with some companies involved more than once. Analysts even suggested that, in 2025, there could be […]
