
Edwards Lifesciences (NYSE:EW) won FDA approval to begin human clinical trials of a new heart valve tissue treatment process that may make the implants more durable.
The next-generation GLX tissue treatment, applied to bovine pericardial heart valves, allows for dry packaging and sterilization and eliminates the need to rinse the valves before implantation.
The treatment also promotes anti-calcification, which may help the implant last longer, according to a press release. The GLX treatment won CE Mark approval in the European Union in May.
Edwards’ FDA-approved clinical trial will enroll between 500 and 700 patients with primary endpoints of safety and effectiveness using historical controls and standard heart valve guidance, according to the release.
The company will initially apply the GLX treatment to its Perimount Magna Ease aortic valves and may later include other devices. The new developments are part of Edwards’ focus on surgical and transcatheter heart valves, which are "aimed at improving ease of use, facilitating less invasive procedures and simplifying device preparation."
"We are excited about beginning the clinical study of this unique tissue treatment platform in the U.S. with our Magna Ease valve," heart valve therapy corporate vice president Donald Bobo Jr. said in prepared remarks. "We hope that this study will be the first step towards establishing a new category of high performance heart valves treated with our GLX platform, and laying a foundation for our next generation valve technologies."
EW shares were up 1.9% to $88.87 as of about 12:20 p.m. today, and financial analysts at Cannacord Genuity boosted their price target from $93 to $103 while maintaining a "buy" rating.