Nashua, New Hampshire-based Conformal shared the data at the 35th Transcatheter Cardiovascular Therapeutics (TCT) in San Francisco. Dr. William Gray presented the “Conformal CLAAS LAAO Device EFS 1-Year TEE Follow-Up.”
“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,” said 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.”
Details of the Conformal Medical early feasibility study
The multi-center, single-arm prospective study enrolled LAAO-indicated patients across 10 U.S. clinical sites. Conformal Medical reported successful CLAAS implants in 59 patients with transesophageal echo (TEE) performed intra-procedurally. The study saw TEE performed at 45 days and again at one-year post-implant to assess safety and performance.
Conformal Medical designed CLAAS to seal the LAA in patients with non-valvular AFib. It aims to reduce the risk of stroke without the need for anticoagulants. The CLAAS device features a proprietary foam-based architecture, addressing a wide spectrum of LAA anatomies with two sizes.
According to the company, it aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram. This would enable physicians to perform the procedure without general anesthesia.
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of this study,” said Dr. 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 continues enrolling patients in its CONFORM pivotal trial to support U.S. commercialization.
