Conformal Medical has announced positive one-year results from the company’s CONFORMAL Early Feasibility Study (EFS).
William Gray (Lankenau Heart Institute, Wynnewood, USA) presented the Conformal CLAAS left atrial appendage occlusion (LAAO) device EFS one-Year TEE follow-up during a moderated abstract session at TCT 2023 (23–26 October, San Francisco, USA).
“I am pleased to report that the high sealing rates observed at implantation persisted at one year with follow up data demonstrating 97.7% seal without significant (>3mm) leaks,” noted Gray. “These results are clinically compelling and support the feasibility of the CLAAS System to safely and effectively provide durable closure for LAAO indicated patients.”
The multicentre, single-arm, prospective study enrolled patients indicated for LAAO at 10 US clinical sites. The CLAAS device was successfully implanted in 59 patients with transesophageal echo (TEE) performed intra-procedurally, at 45 days and again at one year post-implantation to assess the safety and performance of the novel system.
The CLAAS System is designed to seal the LAA in patients with non-valvular atrial fibrillation (AF) to reduce the risk of stroke without the need for anticoagulants. Featuring a proprietary foam-based architecture, the implant addresses a wide spectrum of LAA anatomies with only two sizes.
The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram so that physicians may perform the procedure without general anaesthesia, a significant advancement with the potential to shift clinical practice to a same day, single operator procedure.
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” commented Aaron Kaplan, co-founder and chief medical officer for Conformal Medical. “We look forward to building upon this evidence to further validate the CLAAS technology and its ability to improve and streamline LAAO procedures for operators and patients.”
Conformal Medical is currently enrolling patients in its CONFORM pivotal trial to support U.S. commercialisation.