Two research studies by Egnite Inc. presented at the American College of Cardiology Conference (ACC) could shake up the scope of how aortic stenosis (AS) is understood and treated by physicians.
Following last week’s FDA approval of its Onyx Frontier drug eluting stent (DES), Medtronic plc released results at EuroPCR from a real-world, multicenter prospective study using its Resolute Onyx platform for percutaneous coronary interventions (PCI) in the left main artery. Rehovot, Israel-based Pi-Cardia Ltd. also released early data for patients treated with its Short Cut transcatheter device for coronary obstruction prevention.
The second generation of Boston Scientific Corp.’s Acurate Neo2 valve has demonstrated better performance than its predecessor, showing a threefold reduction of paravalvular leakage (PVL) said researchers. During the hotline/late-breaking trials session on May 17 at the EuroPCR meeting held in Paris, Andrea Buono, interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy, presented results from a large study comparing the performance of Acurate Neo and Acurate Neo2 in 13 Italian centers.
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
As was the case with left atrial appendage closure, renal denervation (RD) as a treatment for hypertension has proven to be difficult to move along into routine clinical usage. New data for a study sponsored by Medtronic plc showed that RD offers a statistically significant improvement over sham treatment in reducing hypertension, but the data do not seem to suggest that patients will be able to drop their antihypertensive medications after RD treatment.
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.
TORONTO – Opsens Inc. has successfully treated 20 patients in the first-in-human study employing a new surgical guidewire to improve procedural workflow during transcatheter aortic valve replacement (TAVR). According to Opsens CEO Louis Laflamme, the Savvywire will be the first guidewire to deliver a valvular prosthesis while allowing continuous hemodynamic pressure measurement during the procedure.
It has long been known that patients recover more quickly from transcatheter aortic valve replacement (TAVR) than from open-heart surgery for valve replacement (SAVR) and results at two years looked good, too, with very similar outcomes. The question remained what happens in the longer term?
Roughly a decade has passed since the FDA first approved a transcatheter aortic valve replacement (TAVR) device, but the U.S. market has proven difficult to access for more than a small number of manufacturers. Abbott Laboratories, of Abbott Park, Ill., is now a player in the market with the FDA’s approval of the Portico device, a product that was first implanted in a human subject in 2011, a clear demonstration of the difficulty of moving these devices from research and development to the market.
The FDA has approved Medtronic plc’s Evolut FX TAVR system for patients with symptomatic severe aortic stenosis. During Medtronic’s fiscal first quarter earnings call CEO Geoffrey Martha said the company will roll the latest generation system out in the U.S. market later this year, with a full launch planned in 2022.