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October 15, 2020

Early Studies Presented for Conformal Medical CLAAS Left Atrial Appendage Closure Technology

October 15, 2020—Conformal Medical, Inc. announced that clinical data from two first-in-human studies of the company's next-generation CLAAS left atrial appendage closure (LAAC) technology were presented in two abstracts by Vivek Reddy, MD, and William Gray, MD, at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

According to the company, Conformal's CLAAS technology is for LAAC in patients with atrial fibrillation. The CLAAS implant, featuring a foam-based architecture, is designed to address the wide spectrum of LAA anatomies with only two sizes and provide simplified delivery without the need for procedural transesophageal echo (TEE), allowing physicians to perform LAA closure without general anesthesia.

In a single-center study (n = 15) conducted in Prague, Czech Republic, investigators evaluated intracardiac echo (ICE) -guided LAA closure under conscious sedation. The two sizes of the CLAAS device were successfully implanted in all patients, effectively addressing LAA diameters from 11 to 28 mm, without the need for procedural TEE. Additionally, all implantationss resulted in successful seals without device-related procedural complications.

"The foam-based CLAAS device allowed me to consistently seal each patient's unique LAA anatomy," commented Dr. Reddy in Conformal Medical's press release. "Our study was performed using ICE and fluoroscopy, without intraprocedural TEE or general anesthesia, and shows the potential of this device, which was easy to deliver and required just two sizes."

A United States multicenter study enrolled 22 patients at four clinical sites. There were no device-related procedural complications, demonstrating closure of LAA diameters from 9 mm to 31 mm. In this study, procedural TEE imaging confirmed conformability with encouraging sealing results.

Dr. Gray commented, "LAA closure is becoming an important alternative to anticoagulation for patients with atrial fibrillation. Though first-generation devices have shown efficacy, they may have significant limitations in some patients. I am very pleased with the initial CLAAS experience. It has the potential for us to treat a broader spectrum of patients and to transform LAAC to a same day procedure."

In 2021, Conformal Medical will begin a randomized pivotal trial that will enroll approximately 1,400 patients at multiple sites globally to investigate the safety and effectiveness of the CLAAS technology compared to Watchman devices (Boston Scientific).

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