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The CLAAS® System by Conformal Medical Demonstrates Sizing Simplicity and Seal Efficiency During AF Symposium Live Case Presentation | ||
By: PR Newswire Association LLC. - 06 Feb 2024 | Back to overview list |
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Novel left atrial appendage occlusion (LAAO) design aims to reduce the risk of stroke NASHUA, N.H., Feb. 6, 2024 /PRNewswire/ -- Conformal Medical, Inc. announced that the company's CLAAS® System was featured in a live case presentation during the 29th Annual AF Symposium. Performed by Dr. Christopher Ellis, Director of the Left Atrial Appendage (LAA) Closure program and Professor of Medicine at Vanderbilt University Medical Center, the case illustrated the compelling design distinctions the CLAAS device offers to both physicians and patients. "With only two sizes, one of which treats nearly 90% of patients, appropriate sizing of the CLAAS device was easy." "This case effectively highlighted the simplicity of the CLAAS System in both sizing and sealing, allowing for a successful procedure," said Dr. Ellis. "With only two sizes, one of which treats nearly 90% of patients, appropriate sizing of the CLAAS device was easy. Once implanted, the foam design conformed to the patient's anatomy to effectively seal the appendage, as confirmed by angiography. The occlusive design aims to eliminate the need for invasive imaging, potentially streamlining the LAAO procedure." The CONFORMAL Early Feasibility Study (EFS) one-year results demonstrated durable closure for LAAO indicated patients with 97.7% seal without significant (>3 mm) leaks at 12 months, comparing favorably with marketed devices.1 The EFS data also confirmed an impressive 97% sizing correlation between TEE and angiography, to quickly confirm CLAAS device sizing.2 The CLAAS implant features a nitinol endoskeleton with a proprietary foam matrix to seal a wide spectrum of LAA anatomies with only two sizes. The system aims to simplify delivery and eliminate the need for procedural transesophageal echocardiogram (TEE) so that physicians may perform the procedure without general anesthesia, a significant advancement with the potential to shift clinical practice to a single operator procedure. "We thank Dr. Ellis and the Vanderbilt team for flawlessly executing this case," commented Dr. Aaron Kaplan, co-founder and Chief Medical Officer for Conformal Medical and Professor of Medicine at Dartmouth Health. "This was an excellent opportunity to showcase the design details that differentiate the CLAAS implant as we progress towards our goal of transforming LAA procedures and expanding the spectrum of treatable anatomies." Conformal Medical is actively enrolling patients in the CONFORM pivotal trial, evaluating the safety and efficacy of the CLAAS System compared to other commercially available LAAO devices. The prospective, multicenter, randomized controlled study will enroll approximately 1,600 patients. About Conformal Medical About Left Atrial Appendage Closure
CAUTION: Investigational Device. The CLAAS System is limited by Federal (or United States) law to investigational use. View original content to download multimedia:https://www.prnewswire.com/news-releases/the-claas-system-by-conformal-medical-demonstrates-sizing-simplicity-and-seal-efficiency-during-af-symposium-live-case-presentation-302055002.html SOURCE Conformal Medical, Inc. |
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