Conformal’s CLAAS System for LAAO Evaluated at 1-Year in Early Feasibility Study

October 24, 2023—Conformal Medical, Inc. announced 1-year results from the CONFORMAL Early Feasibility Study (EFS) of the company’s CLAAS left atrial appendage occlusion (LAAO) system. The CLAAS device is designed to seal the LAA for patients with nonvalvular atrial fibrillation to reduce the risk of stroke without the need for anticoagulants.

The multicenter, single-arm, prospective study enrolled patients indicated for LAAO at 10 clinical sites in the United States. Conformal’s device was implanted in 59 patients. Transesophageal echo was performed intraprocedurally and at 45 days and 1-year postimplantation to assess the safety and performance of the CLAAS device.

William Gray, MD, presented the 1-year findings in a moderated abstract session at TCT 2023, the 35th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 23-26 in San Francisco, California.

Dr. Gray is Professor of Medicine, Thomas Jefferson University, System Chief, Cardiovascular Diseases at Main Line Health, and Co-Director Lankenau Heart Institute in Wynnewood, Pennsylvania.

“I am pleased to report that the high sealing rates observed at implantation persisted at 1-year with follow-up data demonstrating 97.7% seal without significant (>3-mm) leaks,” commented Dr. Gray in Conformal’s press release. “These results are clinically compelling and support the feasibility of the CLAAS system to safely and effectively provide durable closure for LAAO- indicated patients.”

Conformal stated that the CLAAS system, which features the company’s foam-based architecture, addresses a wide spectrum of LAA anatomies with two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram to allow physicians to perform the procedure without general anesthesia, which may potentially shift clinical practice to a same-day, single-operator procedure.

Conformal Medical is currently enrolling patients in its CONFORM Pivotal Trial to support United States commercialization, advised the company.