NASHUA, N.H., Oct. 24, 2023 /PRNewswire/ -- Conformal Medical, Inc. announced today the positive one-year results from the company's CONFORMAL Early Feasibility Study (EFS). Dr. William Gray, Professor of Medicine, Thomas Jefferson University, System Chief, Cardiovascular Diseases at Main Line Health, and Co-Director Lankenau Heart Institute, presented the "Conformal CLAAS LAAO Device EFS 1-Year TEE Follow Up" during the Imaging in LAA Occlusion Procedures moderated abstract session at the 35th Transcatheter Cardiovascular Therapeutics (TCT) meeting, the annual scientific symposium of the Cardiac Research Foundation.
"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 Dr. 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 multi-center, single-arm, prospective study enrolled patients indicated for LAAO at 10 U.S. 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 (Afib) 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 anesthesia, 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 Dr. Aaron Kaplan, co-founder and Chief Medical Officer for Conformal Medical and Professor of medicine at Dartmouth Health. "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. commercialization.
Conformal Medical at Transcatheter Cardiovascular Therapeutics (TCT) 2023
Wednesday, October 25th - Conformal Medical to host a breakfast symposium, "CLAAS Act: Conformal Medical Overview and CONFORM Trial Update" at 6:30am PT in Presentation Theater 1.
Thursday, October 26th - Dr. Shephal Doshi, Executive Director, Heart & Vascular Institute, Providence St. Johns Health Center & Cardiac Electrophysiology at the Pacific Heart Institute, will perform a live case presentation with the CLAAS System at 11:45am PT in the Structural Theater, Hall F North.
About Conformal Medical
Conformal Medical, Inc. is a medical device company developing devices to prevent stroke in patients with non-valvular atrial fibrillation. The company's proprietary technology is intended to make left atrial appendage closure a same day, single operator procedure. For more information, visit https://conformalmedical.com/.
About Left Atrial Appendage Closure
More than six million people in the United States suffer from Afib, placing them at an increased risk of stroke.1 Current standard of care for stroke prevention is chronic oral anticoagulants, which are not well accepted by patients due to concern about associated risk of bleeding. Left Atrial Appendage Occlusion (LAAO) is emerging as an important alternative to blood thinners for preventing strokes in patients with non-valvular Afib. First-generation LAAO devices are an estimated $1.4B global market in 2023 and are expected to grow to over $6B by 2030.2,3
1. Kornej J, Börschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20.
2. Piper Sandler Market Analyst Report, September 2023.
3. Boston Scientific Investor Update, September 2023.
SOURCE Conformal Medical, Inc.