Aegis Medical Innovations Announces FDA Approval of Clinical Trial

Aegis Medical Innovations Inc. has received Investigational Device Exemption approval from the U.S. Food and Drug Administration to initiate a clinical trial in the United States for the Sierra Ligation System (Sierra). Aegis developed the Sierra technology in partnership with the Mayo Clinic in Rochester, Minn.

Sierra could, with additional clinical research, prove to prevent stroke in patients with atrial fibrillation (AF). The clinical trial, called LASSO-AF, 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. Participants will be considered for this trial if their doctor(s) have determined that they have AF, are at increased risk for developing a stroke, and are not ideal candidates for taking anticoagulation drugs.
 
“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, non-vascular LAA closure device, that is designed to protect the patient from AF-related stroke without taking blood thinners,” said Vivek Reddy, M.D., Mount Sinai cardiovascular disease specialist. “In contrast to vascular treatments, this non-vascular approach does not implant a device inside the heart that might migrate or cause clots in the LAA, thus potentially improving patient safety.”
 
“Patients with AF are five times more likely to have a stroke, often due to clots that form in the left atrial appendage. We feel confident that the upcoming trial will show the Sierra procedure to be safe and effective for closing the LAA in patients suffering from AF,” said Trevor McCaw, Aegis founder and president.
 
The hospital approval process has begun for the trial to take place at Mount Sinai in New York, N.Y.; Mayo Clinic; Houston Methodist Hospital, Houston, Texas; and Pacific Heart Institution, Santa Monica, Calif. The clinical trial start date in the United States is scheduled for May.
 
“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,” notes the lead study principal investigator, Dr. Sheldon Singh from Sunnybrook Health Sciences Centre in Toronto, Ontario.
 
The Sierra procedure closes off the LAA by placing a ligature around the base of the LAA and cinching it down with a lock. Closing off the LAA from circulation prevents clots from leaving the appendage, eliminating a potential source of future stroke. Sierra is expected to be one of the simplest, most economical and safest percutaneous procedure for LAA closure. Sierra also has the potential to reduce, and possibly eliminate AF altogether in some patients.
 
Aegis Medical Innovations Inc. is a Vancouver, British Columbia-based company commercializing a minimally invasive device designed to safely reduce the risk of stroke in patients with AF. The privately held firm has developed the world’s only single access non-vascular, epicardial LAA ligation system, called Sierra. Sierra is designed to help prevent strokes in patients with atrial fibrillation.