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: www.aegismedical.net

Related Content

Rhythm Therapeutics gene, stem cell, therapy for atrial fibrillation.
News | Atrial Fibrillation | April 19, 2021
April 19, 2021 — National Heart, Lung, and Blood Institute (NHLBI) has awarded a grant for $462,689 to Rhythm Therape
Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

Medtronic's DiamondTemp Ablation (DTA) system is FDA cleared to treat patients with recurrent, symptomatic paroxysmal atrial fibrillation (AF) and who have been unresponsive to drug therapy. The DiamondTemp system is the first FDA-approved, temperature-controlled, irrigated radiofrequency (RF) ablation system with diamonds currently available to deliver ablations.

News | Atrial Fibrillation | January 29, 2021
January 29, 2021 — The U.S.
Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Patients with atrial fibrillation are at far greater risk of a catastrophic COVID outcomes, so steps should be taken to reduce AFib risks in addition to precautions against COVID like making, hand washing and social distancing. Images include an electromap from an AF ablation procedure and a COVID-19 from the CDC. 

Feature | Atrial Fibrillation | January 27, 2021 | By John D. Day, M.D., T. Jared Bunch, M.D., and Matthew D. LaPlante
In our most challenging and distressing days, it is nice to think about a post-COVID-19 world. 
ECG with paroxysm correct form of atrial flutter. Getty Images

ECG with paroxysm correct form of atrial flutter. Getty Images

News | Atrial Fibrillation | December 23, 2020
December 23, 2020 — The American College of Cardiology (ACC) and the American Heart Association (AHA) has made two up
The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations. #AHA #AHA20 #AHA2020

The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evaluated the detection of silent, or previously undiagnosed, atrial fibrillation (AF) in moderate-risk individuals using the FDA-cleared Zio by iRhythm ambulatory monitoring patch. The results support the clinical value of early screening and targeted detection in moderate-risk populations.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — The three-year clinical outcomes of the mHealth Screening to Prevent Strokes (mSToPS) study evalu
The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting. #AHA #AHA20 #AHA2020

The Medtronic SEEQ mobile cardiac telemetry system, pictured here, and the Icentia CardioSTAT cardiac rhythm monitoring device both found in reased rates of post-operative atrial fibrillation in the SEARCH-AF trial presented at the American Heart Association annual meeting.

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 — Atrial fibrill...
The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  #AHA #AHA2020 #AHA20

The Medtronic Arctic Front cryoballoon balloon was used a a front-line treatment of AF in the EARLY-AF trial. It was found to be better than anti-arrhythmic drugs in preventing the recurrence of abnormal heart rhythm (atrial tachyarrhythmia, atrial fibrillation), and improve patient well-being.  

News | Atrial Fibrillation | November 16, 2020
November 16, 2020 – Doctors from the Mo...