Edwards Picks Up FDA Nod Ahead of TCT Face-off with Abbott

Edwards Lifesciences has won a nod from FDA for the Pascal Precision valve repair system for transcatheter edge-to-edge repair (TEER). The device is designed to be used in the treatment of patients with degenerative mitral regurgitation (DMR).

In August, the Irvin, CA-based company won a CE mark for the system – which covers both mitral and tricuspid regurgitation.

"Patients suffering with debilitating symptoms as a result of degenerative mitral regurgitation represent a large and significantly underserved group in the US," said Bernard J. Zovighian, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies.

FDA’s nod also comes right ahead of the 34th Transcatheter Cardiovascular Therapeutics (TCT) symposium which will contain a face-off of sorts between Edwards and Abbott’s mitral valve solutions. The CLASP IID trial, comparing the safety and efficacy of the Pascal Precision system to Abbott Laboratories MitraClip in patients with DMR, will be presented in a late-breaking session at TCT. 

“We note the study was powered for non-inferiority,” Marie Thibault, an analyst with BTIG, wrote in research notes. “Edwards will also host an investor update Saturday evening to recap the new pivotal trial data and provide updates on its latest technologies.”

Results from the study have the potential to be significant, as Abbott’s MitraClip has had a huge runway in the mitral valve repair space. The device first won approval from FDA in 2013 and won an additional indication to address the secondary form of mitral regurgitation in 2019.