A pivotal trial of Edwards Lifesciences’ (NYSE:EW)Pascal mitral valve repair system is now underway, with the first procedure being performed this week at Atlantic Health System’s Morristown Medical Center, the group said.
The study, dubbed the Clasp IID trial, will explore the safety and efficacy of Irvine, Calif.-based company’s Pascal TMVR system in treating patients with degenerative mitral valve regurgitation, the research institution said.
“As a nationally ranked heart hospital, Morristown Medical Center is proud to be the first hospital in the world to implant this device as part of this pivotal trial. Our cardiac team was chosen for this prestigious opportunity based on our expertise, excellent outcomes, best-in-class imaging, and extensive experience with transcatheter valve replacement or repair procedures,” trial investigator Dr. Robert Kipperman of the Morristown Medical Center said in a prepared statement.
“We are extremely honored to implant the first device in this trial and to make this therapy available for those we care for,” principal investigator Dr. Linda Gillam of the Morristown Medical Center said in a press release.
Last month, Edwards Lifesciences said that it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis.