United States Feasibility Study Begins for Conformal LAA Seal for Stroke Prevention
April 9, 2019—Conformal Medical, Inc. announced the first human use of its left atrial appendage (LAA) occlusion technology for the prevention of stroke in patients with atrial fibrillation (AF). Treatment of a patient with the company's Conformal LAA seal was performed by Robert Sommer, MD, at New York-Presbyterian/Columbia University Medical Center in New York, New York.
The first patient is a mountain biker who is 63 years old, has longstanding AF and has had multiple bleeding episodes on oral anticoagulation. The Conformal LAA seal was successfully implanted, and the patient was discharged the next day on dual antiplatelet therapy, as indicated by the study protocol.
This case initiates a multicenter study performed at United States sites as part of the FDA's Early Feasibility Study (EFS) program. Conformal obtained investigational device exemption approval for this first human use of the Conformal LAA seal through the EFS program.
According to the company, the Conformal LAA seal is designed to allow the implant to adapt to the unique shape of each patient's anatomy for optimal sealing. The device's foam-based architecture is designed for simpler, more forgiving delivery that may eliminate the need for general anesthesia.
In Conformal's announcement, Dr. Sommer commented, "It is exciting to participate in the first-in-human use of the Conformal device. The form-fitting seal is a promising advance in LAA closure for stroke prevention."
Martin B. Leon, MD, Director of the Center for Interventional Vascular Therapy at Columbia, added, "Columbia is excited to be the first to introduce this technology to patients. I applaud Conformal's commitment to utilize the FDA's EFS Program. The ability to participate in early feasibility studies is important for the United States device ecosystem as we strive to develop new therapies to better serve our patients."