Edwards Lifesciences Archives - Page 7 of 7

Edwards Lifesciences wins approval in China for Sapien 3

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]

Edwards Lifesciences (NYSE:EW) announced today that it received regulatory approval in China for its Sapien 3 transcatheter heart valve.

Sapien 3 TAVR (transcatheter aortic valve replacement) is used in the treatment of patients suffering from severe, symptomatic aortic stenosis (AS) who are at high risk for or unable to undergo open-heart surgery.

According to a news release, the Sapien 3 TAVR valves are the most widely studied transcatheter valves, treating more than 30,000 patients in clinical trials across 65 different countries. The China Sapien 3 study supported the regulatory approval, having provided positive real-world results alongside three randomized controlled “Partner” studies.

Edwards offers the valve in 20mm, 23mm, 26mm and 29mm sizes for high-risk patients in China. The Irvine, Calif.-bas…

Edwards’ Todd Brinton on finding a place in medtech

In this week’s DeviceTalks Weekly podcast , Todd Brinton, MD, corporate vice president of advanced technology and chief scientific officer at Edwards Lifesciences, delivers heartfelt and hard won advice to professionals looking to find a home in the medtech industry.

Brinton’s own path to Edwards took an unusual root, starting first at medtech start-ups before he forced his way into medical school. After securing his MD, he landed in a job he thought he’d never have, learned to love it and then gathered the courage to walk away from it to pursue his new role at Edwards.

DeviceTalks Host Tom Salemi spoke with Brinton in March.

DeviceTalks by MassDevice · DTW’s Commencement Speaker- Todd Brinton, MD, Edwards Lifesciences on building a career in medtech

Edwards lands CE Mark for Pascal transcatheter valve repair system to treat TR

Edwards Lifesciences (NYSE:EW) announced today that it received CE Mark approval for its Pascal transcatheter valve repair system for treating tricuspid regurgitation (TR).

Pascal won its indication in Europe for the percutaneous reconstruction of the tricuspid valve through leaflet repair by tissue approximation. The device uses clasps and paddles to grasp the leaflets and facilitate coaptation, while the spacer is designed to fill the regurgitant orifice area and prevent backflow.

The clasps can be operated independently to facilitate optimized leaflet capture and the implant can then be elongated to a narrow profile to allow for safe maneuvering in dense chordal anatomy, according to a news release.

Edwards touted early clinical evidence of procedural success and clinical improvements, with Pascal demonstrating sustained TR reduction at 30 days. The company is conducting the Clasp II TR pivotal study to investigate Pascal in patients with symptomatic …