Big Wins at TCT for Edwards & TEER Procedures

Edwards Lifesciences can say two things about its Pascal Precision Valve Repair System. The first is that the technology has FDA approval and the second is that in a study, the device showed its non-inferiority to Abbott Laboratories’ MitraClip.

Study results from the CLASP IID trial were presented this past weekend at the Transcatheter Cardiovascular Therapeutics (TCT) annual symposium in Boston.

The devices are for transcatheter edge-to-edge repair (TEER) to be used in the treatment of patients with degenerative mitral regurgitation (DMR).

Results were reported on 180 patients with 2:1 randomization (117 PASCAL / 63 MitraClip), with echo core lab adjudication. The trial included 43 sites in the US, Canada, and Europe, with most clinical operators new to using the PASCAL system and all having experience with the MitraClip system.

Patients enrolled in the CLASP IID pivotal trial had severe symptomatic DMR and were determined to be at prohibitive surgical risk. Results from the study show that Pascal had Low composite major adverse event rate of 3.4% at 30 days, and significant and sustained MR reduction with 97.7% of patients achieving MR ≤2+ at six months. 

The device demonstrated significant and sustained MR ≤1+ with 83.7% of patients at MR ≤1+ at six months. The Pascal System’s results also showed favorable ventricular remodeling with improved stroke volume, and patients receiving the device experienced significant improvements in functional capacity and quality of life.

In a research note, Marie Thibault, an analyst with BTIG wrote, “We view CLASP IID as a clear success in showing Pascal is safe, effective, and commercially viable.”

There will likely be comparisons now between Abbott’s MitraClip and Edwards, Pascal – but physicians discussing the CLASP IID findings at TCT cautioned against such direct comparisons, according to Thibault.

Perhaps more than anything, it should show the effectiveness of TEER procedures. Abbott had a strong showing. Results from the Abbott Park, IL-based company’s EXPAND post-approval-study show MR < 1 in 91% of patients at 30 days.

"MitraClip therapy has fundamentally changed the way doctors treat mitral regurgitation, provides a valuable therapy option that does not require open-heart surgery, and goes beyond simply managing symptoms with medications," said Jason Rogers, M.D., professor of cardiovascular medicine and director of interventional cardiology and structural heart training programs at the University of California, Davis Medical Center. "These late-breaking data  demonstrate and strengthen the evidence that Abbott's MitraClip system consistently reduces  MR in a broad range of patients, while restoring proper function of the mitral valve and  improving patients' quality of life."