Technology | Left Atrial Appendage (LAA) Occluders | March 22, 2017

FDA Approves LASSO-AF Clinical Trial for Sierra Ligation LAA Occluder System

Device has potential to reduce stroke in patients with atrial fibrillation

Aegis Medical Innovations, Sierra Ligation System, U.S. clinical trial, FDA approval, LAA occluder

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.

Watch a video demonstration of LAA closure using Sierra.

For more information:

Related Content

Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery| September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Sponsored Content | Videos | Structural Heart Occluders| September 13, 2017
Ziyad Hijazi, M.D., MPH, MSCAI, FACC, director of the cardiac program and chair of the Department of Pediatrics at Si
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
TCT 2017 late-breaking trials and studies that will be presented on the latest cardiology technology clinical trials.
Feature | September 11, 2017
September 11, 2017 — From numerous high-quality submissions, Transcatheter Cardiovascular Therapeutics (TCT) has sele
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery| September 08, 2017
September 8, 2017 — ClearFlow Inc.
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
Overlay Init