October 16, 2020 — Positive clinical data from first-in-human studies of the Conformal Medical left atrial appendage closure (LAAC) CLAAS device performed in the U.S. and Prague were presented at 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual meeting. Two two abstracts were presented by William Gray, M.D., from Lankenau Heart Institute, Wynnewood, Penn., and Vivek Reddy, M.D., from Mount Sinai Hospital in New York.
Conformal Medical's CLAAS Device
Both studies investigated Conformal's CLAAS Technology, a next-generation solution for sealing the left atrial appendage (LAA) in patients with atrial fibrillation (AF). Featuring a proprietary foam-based architecture, the CLAAS implant 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 LAAC without general anesthesia.
The Prague single-center study (n=15) investigated 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 mm to 28 mm, without the need for procedural TEE. Additionally, all implants 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," Reddy explained. "Our study was performed using intra-cardiac echo (ICE) and fluoroscopy, without intra-procedural TEE or general anesthesia, and shows the potential of this device, which was easy to deliver and required just two sizes."
The U.S. multi-center 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.
"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," Gray said. "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 its 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 Boston Scientific's Watchman products.
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. LAAC is emerging as an important alternative to blood thinners for preventing strokes in patients with AFib. First-generation LAAC devices are an estimated to reach $700 million global market in 2021 and are expected to grow to over $2 billion in the next five years.[2]
For more information: conformalmedical.com/
Find additional TCT 2020 news, video and late-breaking studies
References:
1. https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_atrial_fibrillation.htm
2. Morgan Stanley Market Analyst Report September 2020
