LASSO-AF Clinical Trial Approved for Aegis Medical Innovations' Sierra Ligation System

March 22, 2017—Aegis Medical Innovations Inc. announced that it has received investigational device exemption approval from the US Food and Drug Administration to initiate a clinical trial in the United States for the Sierra ligation system, which the company developed in partnership with the Mayo Clinic in Rochester, Minnesota. The Sierra device is being developed for the prevention of stroke in patients with atrial fibrillation (AF).

According to the company, the LASSO-AF clinical trial is an early feasibility study designed to assess the safety and procedural success of Sierra in closing off the left atrial appendage (LAA) using a minimally invasive epicardial approach. The trial will enroll patients if their doctor(s) have determined that they have AF, are at increased risk for developing a stroke, and are not ideal candidates for anticoagulation drug therapy.

The clinical trial is scheduled to begin in the United States in May 2017. The hospital approval process has begun for the trial to take place at Mount Sinai in New York, New York; the Mayo Clinic; Houston Methodist Hospital in Houston, Texas; and Pacific Heart Institution in Santa Monica, California.

In the company's announcement, Vivek Reddy, MD, commented, “For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, nonvascular LAA closure device that is designed to protect the patient from AF-related stroke without taking blood thinners. In contrast to vascular treatments, this nonvascular approach does not implant a device inside the heart that might migrate or cause clots in the LAA, thus potentially improving patient safety.” Dr. Reddy is a Mount Sinai Cardiovascular Disease Specialist in New York, New York.

The lead Principal Investigator for LASSO-AF is Sheldon Singh, MD, who is with Sunnybrook Health Sciences Center in Toronto, Ontario. Dr. Singh stated, “This study will confirm the safety of the Sierra device for patient use and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention.”