Conformal Medical’s CLAAS LAAO Device Evaluated in Published Preclinical Study

January 5, 2023—Conformal Medical, Inc., which is developing next-generation left atrial appendage occlusion (LAAO) technology, announced the publication of a preclinical study of the company’s CLAAS LAAO device in a healthy canine model. The study demonstrated key features of the device, including the ability to position, deploy, and seal the left atrial appendage (LAA) with appropriate healing at 150 days.

The article, “Foam-based Left Atrial Appendage Closure (CLAAS) Device: Evaluation in a Chronic Canine Model,” was published by Aaron V. Kaplan, MD, et al online in the Journal of the Society for Cardiovascular Angiography and Interventions.

“This study validates the design features of Conformal’s CLAAS foam-based implant that enable it to fill in gaps and definitively seal, regardless of the LAA shape,” commented William Gray, MD, in the company’s press release. Dr. Gray is senior investigator of the study, Chief of Cardiovascular Disease at Main Line Health, and Co-Director of Lankenau Heart Institute in Wynnewood, Pennsylvania.

Dr. Kaplan, Co-Founder and Chief Medical Officer of Conformal Medical, added, “We are pleased to have these data published, demonstrating the ability of the CLAAS implant to successfully close the LAA in a healthy canine model with normal local healing without signs of device-related thrombus, thrombus embolization, infection, or toxicity. We look forward to further validating its performance in the clinic as we accelerate enrollment in the CONFORM pivotal trial.”

In June 2022, Conformal Medical announced the launch of the CONFORM pivotal trial that will evaluate the safety and efficacy of the CLAAS system compared to commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the United States and Japan. The study, conducted under an investigational device exemption, will support FDA premarket approval of the CLAAS system.

According to the company, CLAAS is designed to seal the LAA in patients with nonvalvular atrial fibrillation to reduce the risk of stroke without the need for anticoagulants. Featuring the company’s foam-based architecture, the CLAAS implant is designed to conform to a broad range of LAA anatomies with only two sizes and aims to simplify the procedure by allowing off-axis positioning while providing a more uniform seal.

The implant also aims to eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anesthesia, which has the potential to shift clinical practice to a single-operator procedure performed under conscious sedation without general anesthesia, advised Conformal Medical.