Nashua, NH – April 9, 2019 – Conformal Medical, Inc., developer of the Conformal Left Atrial Appendage Seal for LAA occlusion, reports the first human use of its proprietary technology for the prevention of stroke in patients with atrial fibrillation (AFib). The case was performed by Robert Sommer, MD at New York-Presbyterian/Columbia University Medical Center in New York City. This initiates a multi-center study performed at US sites as part of the FDA’s Early Feasibility Study (EFS) Program.
Over five million people in the United States suffer from AFib, putting them at increased risk of stroke. The current standard of care for stroke prevention in AFib patients is chronic use of oral anticoagulants, which can cause uncontrolled bleeding. The left atrial appendage (LAA) is a pouch off the upper heart chamber where clots associated with stroke in AFib patients form. LAA closure, which eliminates the need for anticoagulation, is emerging as an alternative stroke prevention strategy. The LAA sealing procedure is performed minimally invasively from a small incision in the groin.
The innovative design of the Conformal LAA Seal allows the implant to adapt to the unique shape of each patient’s anatomy for optimal sealing. Its unique foam-based architecture is designed for simpler, more forgiving delivery which may eliminate the need for general anesthesia.
“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.” said Dr. Sommer.
Conformal obtained Investigational Device Exemption (IDE) approval for this first human use of the Conformal LAA Seal through the FDA’s Early Feasibility Study Program. The EFS Program was introduced in 2013 to encourage the early clinical investigation of medical devices in the US, enabling companies to collect vital data for product development while adhering to exacting human subject protections provided by the IDE regulations.
“Columbia is excited to be the first to introduce this technology to patients,” stated Martin B. Leon, M.D., Director of the Center for Interventional Vascular Therapy at Columbia. “I applaud Conformal’s commitment to utilize the FDA’s EFS Program. The ability to participate in early feasibility studies is important for the US Device ecosystem as we strive to develop new therapies to better serve our patients.”
“First-in-human use marks an important milestone for advancing our approach to stroke prevention,” says Andy Levine, President and CEO of Conformal Medical. “The experienced team at Columbia is providing valuable insights for optimizing the care of their patients.”
About the First Patient
The first patient is a 63-year-old mountain biker with longstanding AFib, who has had multiple bleeding episodes on oral anticoagulation. The Conformal LAA Seal was successfully implanted, and the patient was discharged the following day on dual antiplatelet therapy, as indicated by the study protocol.
About Conformal Medical
Conformal Medical, Inc. is a medical device company founded in 2016 to develop devices to prevent stroke in patients with non-valvular atrial fibrillation. The company’s proprietary technology will help left atrial appendage closure to meet its true potential. For more information, email firstname.lastname@example.org.
About the EFS Program
For more information on FDA’s EFS Program, click here.