Edwards Lifesciences (NYSE:EW) won an investigational device exemption from the FDA to begin a clinical trial of its Edwards Intuity heart valve.
The device maker’s Transform trial is the 1st of its kind in the U.S. for a rapid deployment system for surgical aortic valve replacement, according to a press release.
"The Edwards Intuity valve system is based on the design of our proven market-leading surgical valves, and includes a novel delivery system designed to enhance control, accuracy and simplicity throughout the implantation," Edwards heart valve therapy vice president Donald Bobo Jr. said in prepared remarks. "This innovative platform was developed with key insights from leading surgeons who share our commitment to the continued advancement of therapeutic options for their patients."
The Edwards Intuity valve, which won CE Mark approval in the European Union in February, is a minimally invasive option for patients in need of aortic valve replacement.
The device features a bovine pericardial heart valve and a balloon-expandable frame designed to "facilitate small-incision surgery and rapid valve deployment with the goal of enabling faster procedures," according to the release.
The new study will observe the safety and effectiveness of the Edwards Intuity system in a prospective, multi-center trial with standard guidance and historical controls. The trial is expected to enroll 500-700 patients.
"This new valve platform is designed to provide a number of patient benefits, and we look forward to learning how a smaller incision and more rapid valve implantation may result in reduced operative time and improved patient outcomes," Swedish Heart & Vascular Institute chief of cardiac surgical services and Edwards consultant Dr. Glenn Barnhart said in prepared remarks.
Wall Street didn’t seem to react much to the news, with Edwards shares staying relatively flat at $103.43 as of about 11:30 a.m. today.
Edwards recently released 1-year data from its European multi-center Triton trial, which treated 152 patients at 6 European centers.
Researchers reported a 97.3% procedural success rate, single-digit mean gradient after 1 year for all valve sizes, a low incidence of paravalvular leaks and a 94% survival rate.
The study also found shortened procedure times and less patient time spent on cardiopulmonary bypass machines, according to a separate press release.
