Medtronic Launches Penditure LAA Exclusion System in the United States

November 27, 2023—Medtronic announced the United States launch of the Penditure left atrial appendage (LAA) exclusion system, an implantable clip preloaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures.

As noted in the press release, the American College of Cardiology, American Heart Association, and Society of Thoracic Surgeons guidelines recommend that patients with preoperative atrial fibrillation undergoing concomitant cardiac surgery should have their LAA closed to reduce stroke risk.

According to the company, the Penditure clip is curved to match atrial anatomy and does not include fabric for atraumatic closure and reduced inflammation. It is designed to be recaptured, repositioned, and redeployed after initial deployment during a procedure.

Medtronic acquired the device technology from Syntheon LLC in August 2023 to expand its cardiac surgery profile to include LAA management. The first cases were performed by Gorav Ailawadi, MD, at University of Michigan Frankel Cardiovascular Center in Ann Arbor, Michigan, and Basel Ramlawi, MD at Lankenau Heart Institute, part of Main Line Health, in Philadelphia, Pennsylvania.

“This launch brings innovation to the space, offering a solution that is low profile and can provide more control and visibility than ever before,” commented Dr. Ailawadi. “And while we hope we don’t need to use it often, the Penditure clip is recapturable and redeployable should we ever want to reposition an already deployed clip, which is a nice safety feature.”

Dr. Ramlawi added, “The Penditure device was effective at completely excluding the LAA at its base, achieving an excellent result surgically and on echo imaging. Given successful initial experience, surgeons can place the device safely and reliably while having the added benefit of repositionability if needed for optimal placement.”

Enrollment in the multicenter, single-arm, nonrandomized, interventional, post-market CLIP-IT study is planned for early 2024. The trial will aim to evaluate the performance and clinical outcomes of Penditure in approximately 150 patients undergoing concomitant cardiac surgery at 25 United States sites.

The Penditure LAA exclusion system has FDA 510(k) clearance and is commercially available in the United States on a limited basis.