March 22, 2017 — Aegis Medical Innovations Inc. announced that it has received Investigational Device Exemption approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical trial in the U.S. for its Sierra Ligation System medical device. 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), according to the company.
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.”
The hospital approval process has begun for the trial to take place at Mount Sinai in New York, N.Y.; Mayo Clinic, Rochester, Minn.; Houston Methodist Hospital, Houston; and Pacific Heart Institution, Santa Monica, Calif. The clinical trial start date in the U.S. is scheduled for May 2017.
“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,” noted the lead study principal investigator, Sheldon Singh, M.D., 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.
For more information: www.aegismedical.net