Health Canada Approves LASSO-AF Trial for the Aegis Sierra Ligation System
June 5, 2017—Aegis Medical Innovations Inc. announced that it has received investigational testing authorization (ITA) approval from Health Canada to initiate the LASSO-AF clinical trial in Canada for the company's Sierra ligation system. In March, Aegis announced investigational device exemption (IDE) approval from the US Food and Drug Administration to initiate LASSO-AF in the United States. The company is based in Vancouver, British Columbia.
The LASSO-AF clinical trial, which is expected to start in July 2017, is designed to assess the safety and procedural success of the Sierra device for left atrial appendage (LAA) closure in patients with atrial fibrillation (AF).
In Canada, the trial will be conducted at Royal Jubilee Hospital in Victoria, British Columbia; St. Paul's Hospital in Vancouver, British Columbia; and Sunnybrook Health Sciences Center in Toronto, Ontario. In the United States, the hospital approval process for the trial has begun at Houston Methodist Hospital in Houston, Texas; Mayo Clinic in Rochester, Minnesota; Mount Sinai in New York, New York; and Pacific Heart Institution in Santa Monica, California.
According to Aegis, the Sierra is a minimally invasive, nonvascular LAA closure device that accesses the heart through the pericardium by a single, small puncture below the rib cage. The system delivers a ligature around the base of the LAA and cinches it down with a lock. The ligature and lock remain implanted and are designed to permanently close the LAA.
Because the device never enters the blood stream or the inside of the patient’s heart during delivery or implantation, the need for blood thinners during and after the procedure is potentially eliminated. Also, by not needing a transseptal puncture to access the LAA, the Sierra device has the potential for substantial risk reduction for patients, stated the company.
Aegis developed the Sierra technology in collaboration with experts at Mayo Clinic in Rochester. Paul Friedman, MD, a Mayo Clinic cardiologist who has collaborated with Aegis, commented in the company's press release, "For many patients anticoagulants pose an important bleeding risk. Aegis has developed a minimally invasive LAA closure device that, if effective, could reduce the risk of AF-related stroke without requiring patients to take blood thinners during or after treatment. Sierra is a minimally invasive, nonvascular approach to close off the LAA. With this approach, in contrast to endovascular closure plugs, there isn’t a device left inside the heart which may add to procedural and long-term safety."