FDA green-lights Aegis Medical trial for Sierra ligation device

Aegis Medical Innovations said today it won FDA investigational device exemption approval to begin a clinical trial of its Sierra Ligation System designed for left atrial appendage closure.

In the trial, Vancouver-based Aegis Medical aims to explore the safety and procedural success of the minimally invasive Sierra procedure in closing off the left atrial appendage in patients with atrial fibrillation.

“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,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.

“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. 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,” Dr. Vivek Reddy of Mount Sinai said in a press release.

The Sierra procedure involves closing off the LAA by placing a ligature around the base of the LAA and clinching it down with a lock. LAA closure procedures look to prevent clots from leaving the closed off LAA and eliminate them as a potential source for future stroke.

“Patients with AF are 5 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,” Aegis prez & founder Trevor McCaw said in a prepared statement.

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