VANCOUVER, BC (May 29, 2017) – Aegis Medical Innovations Inc. (Aegis) today announced that it has received Investigational Testing Authorization (ITA) approval from Health Canada to initiate a clinical trial called LASSO-AF in Canada for its medical device the Sierra Ligation System (Sierra). Earlier this year, Aegis also received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate LASSO-AF in the U.S.. Aegis developed the Sierra technology – a new approach to left atrial appendage (LAA) closure – in collaboration with experts at Mayo Clinic in Rochester, MN. Patients with atrial fibrillation (AF) are five times more likely to have a stroke, often due to clots that form in the LAA. With additional clinical research Sierra could prove to reduce the risk of stroke in patients with AF.
The LASSO-AF study is designed to assess the safety and procedural success of Sierra in closing off the LAA. The study will be carried out at the following Canadian institutions: Royal Jubilee Hospital, in Victoria, BC; St. Paul’s Hospital in Vancouver, BC and Sunnybrook Health Sciences Centre in Toronto, ON. The hospital approval process has also begun for the trial to take place at Houston Methodist Hospital in Houston, TX; Mayo Clinic in Rochester, MN; Mount Sinai in New York, NY; and Pacific Heart Institution in Santa Monica, CA. The anticipated clinical trial start date is June 2017.
To reduce the risk of stroke, anticoagulants are often prescribed to patients with AF. “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,” said Paul Friedman, M.D., Mayo Clinic cardiologist who has worked in collaboration with Aegis. “Sierra is a minimally invasive, non-vascular approach to close off the left atrial appendage. 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.”
“The Sierra device permits LAA closure from the outside of the patient’s heart with only a single sheath access. This should make the procedure safer than other techniques which require entering the inside of the heart with a permanent implant,” said Trevor McCaw, Aegis Founder and President. “LASSO-AF is the first step in showing that LAA closure with the Sierra device is safe, and has the potential to prevent strokes in patients with AF.”
Sierra – How it Works
The Sierra procedure closes off the LAA – a pouch connected to the top left heart chamber. Sierra accesses the heart through the pericardium (the protective membrane surrounding the heart) by a single small puncture below the rib cage. After entering the pericardial space, the system delivers a ligature (small loop) 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. Closing off the LAA from circulation has been demonstrated to prevent clots from forming in the appendage, eliminating a potential source of future stroke, and potentially lowering arrhythmia risk.
Sierra is the world’s only minimally invasive, non-vascular LAA closure device. This means that unlike endovascular LAA closure devices, Sierra never enters the blood stream or the inside of the patient’s heart during its delivery or implantation. This potentially eliminates the need for blood thinners during and after the procedure. Furthermore, the Sierra procedure eliminates the requirement for transseptal puncture (placing a hole in the center of the heart) to access the LAA, which is required by all other minimally invasive LAA closure procedures. Avoiding transseptal puncture has the potential for substantial risk reduction for patients.
Compared to all existing LAA closure treatments for patients with AF, Sierra is expected to be an effective, simpler, more economical and safer percutaneous procedure that will provide significant advantages to patients, physicians and the healthcare system.
Click here to see a video demonstration of LAA closure using Sierra.
About Aegis Medical Innovations Inc.
Aegis Medical Innovations Inc. is a privately held Vancouver-based company that is focused on the commercialization of a minimally invasive device designed to safely reduce the risk of stroke in patients with AF. Aegis, in collaboration with Mayo Clinic experts, 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. For more information on Aegis and Sierra visit www.aegismedical.net.
 Mayo Clinic and Dr. Paul Friedman have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.