Medtronic has launched a heart implant designed to help lower the lifetime risk of stroke in people with atrial fibrillation and to serve as a valuable addition to patients who are already undergoing open cardiac surgery.
The Penditure device includes a small, curved clip made to fit along the heart muscle wall. It is used to seal off a small pocket in the left atrium, where potentially dangerous blood clots are more likely to form if a person has an irregular heartbeat.
The company said that it acquired the exclusion system implant from the medical device incubator Syntheon this past August, around the same time the Penditure obtained a 510(k) clearance from the FDA. The financial terms of the deal were not disclosed.
The acquisition expands Medtronic’s structural heart portfolio into left atrial appendage management for the first time. The field already counts other devices with similar functions developed by Abbott and Boston Scientific.
Their closure implants—the Amplatzer Amulet and the Watchman, respectively—are each designed to expand and fill the small pocket in the cardiac muscle. However, unlike the Penditure, they can be delivered to the heart through their own minimally invasive, transcatheter-based procedures.
Instead, the Penditure clip requires a quick detour during an ongoing surgery that could have a big impact on a patient later in life.
A randomized study found in 2021 that by taking up to 10 minutes to close off the left atrial appendage—whether through sutures or other medical devices—surgeons could reduce the number of ischemic strokes by up to 42%.
This benefit could come on top of common blood thinner regimens and could combine a mechanical approach with a medical one without adding new side effects, the study found. Currently, guidelines from the American College of Cardiology, American Heart Association and Society of Thoracic Surgeons all recommend that patients with afib who have a heart surgery scheduled should also have their left atrial appendage closed.
To save even more surgical time, the Penditure clip comes preloaded on a single-use delivery system, and it can be recaptured, repositioned and redeployed during a procedure, according to Medtronic.
The company said it plans to launch a single-arm, postmarket study of the device early next year to further evaluate its performance and clinical outcomes in about 150 patients.