The CLAAS® System by Conformal Medical Demonstrates Sizing Simplicity and Seal Efficiency During AF Symposium Live Case Presentation

Novel left atrial appendage occlusion (LAAO) design aims to reduce the risk of stroke
without the need for anticoagulants in patients with atrial fibrillation (Afib)

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 29^th 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.

"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
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.³ 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.

1. Gray W, Conformal Early Feasibility Study: 12 Months Results. Presented at TCT 2023
2. Gray W, Real-Time Atrial Appendage Assessment for LAAO-CLAAS Device Selection: Angiography vs TEE. Presented at CRT 2023
3. 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.

CAUTION: Investigational Device. The CLAAS System is limited by Federal (or United States) law to investigational use.

SOURCE Conformal Medical, Inc.

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