Conformal Medical’s CLAAS LAAO Device Begins CONFORM Pivotal Trial

June 17, 2022—Conformal Medical, Inc. announced the launch of the CONFORM pivotal trial that will evaluate the safety and efficacy of the company’s CLAAS left atrial appendage occlusion (LAAO) system compared to commercially available LAAO devices. The study, conducted under an investigational device exemption, will support FDA premarket approval of the CLAAS system.

According to Conformal Medical, the prospective, multicenter, randomized controlled trial will enroll approximately 1,600 patients in the United States, Canada, and Japan. To date, more than 75 patients have been successfully implanted with the CLAAS system as part of the company’s early feasibility studies (EFSs).

The CLAAS system is designed to seal the left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation (AF) to reduce the risk of stroke without the need for anticoagulants. The system features the company's foam-based architecture. The implant is designed to address a wide spectrum of LAA anatomies with only two sizes.

The company noted that the system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anesthesia, with the potential to shift clinical practice to a same day, single-operator procedure.

The first patients in the pivotal study were enrolled at two sites in the United States by coprincipal investigators Shephal Doshi, MD, and William Gray, MD. Dr. Doshi is Executive Director, Heart & Vascular Institute, Prov. St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute in Santa Monica, California. Dr. Gray is System Chief, Cardiovascular Diseases at Main Line Health and Professor at Lankenau Institute for Medical Research in Wynnewood, Pennsylvania.

In the company’s press release, Dr. Gray stated, “I am excited to initiate this important trial and for the potential of this innovative technology to expand treatment options for patients with AF. In this study, we will be evaluating the novel foam-based design of the CLAAS implant against the existing FDA-approved devices to evaluate performance on several metrics, including procedural safety, completeness of seal, and incidence of device-related thrombus.”

Dr. Doshi commented, “Based on our experience in the EFS, the CLAAS system is highly conformable to accommodate different anatomies. The study is designed to demonstrate the benefits of this technology for both implanting physicians and patients.”

“We are pleased to enroll the first patients in the CONFORM trial, an important milestone for the company,” commented Andy Levine, President and CEO of Conformal Medical, in the press release. “Kicking off the study builds on the strong momentum from our EFS experience.”

Mr. Levine further advised, “This IDE includes the rigor of both a randomized study comparing CLAAS to commercial devices, and a separate substudy designed to support a conscious sedation, intracardiac echocardiography–driven approach; a critical step towards our goal to transform LAAO and reduce the risk of stroke, without the need for anticoagulants.”