Conformal Medical Presents Early Feasibility Study Results for LAA Assessment

February 27, 2023—Conformal Medical, Inc. announced the presentation of results from the CONFORMAL early feasibility study, which is evaluating the use of angiography compared to transesophageal echocardiogram (TEE) for left atrial appendage (LAA) assessment.

William Gray, MD, presented the findings during the LAA Closure Forum at CRT 2023, the Cardiovascular Research Technologies conference held February 25-28 in Washington, DC.

“This study evaluated baseline TEE and angiographic data collected from 36 atrial fibrillation (AF) patients who were deemed appropriate for left atrial appendage occlusion (LAAO),” explained Dr. Gray in the company’s press release. “The complete paired images were analyzed for LAA diameter and depth to facilitate CLAAS device size selection. Results demonstrated a 97% agreement in device size selection between the two imaging modalities.” Dr. Gray is Codirector of the Lankenau Heart Institute in Wynnewood, Pennsylvania, and Professor of Medicine at Thomas Jefferson University in Philadelphia, Pennsylvania.

According to the company, the CLAAS system is designed to seal the LAA in patients with nonvalvular AF to reduce the risk of stroke without the need for anticoagulants. The CLAAS device, which features a 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 TEE so that physicians may perform the procedure without general anesthesia.

Aaron V. Kaplan, MD, Professor of Medicine at Dartmouth College’s Geisel School of Medicine in Lebanon, New Hampshire, is Conformal’s Cofounder and Chief Medical Officer.

“The novel CLAAS device is designed to streamline LAAO procedures,” stated Dr. Kaplan in the Conformal press release. “This study demonstrates that with only two sizes, the CLAAS implant requires minimal imaging, an important step as we look to transform the procedure to a single-operator, same-day procedure.”

Conformal Medical advised that it is actively enrolling patients in the CONFORM pivotal trial, which is evaluating the safety and efficacy of the CLAAS system compared to other commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients in the United States and will support FDA premarket approval.