Medtronic has secured a CE Mark approval in Europe for its surgical implant to close the heart’s left atrial appendage, aimed at reducing the long-term risk of stroke that’s higher among people with an irregular heartbeat, such as atrial fibrillation.
The Penditure system previously obtained an FDA green light in late 2023—since then, Medtronic said it has delivered more than 10,000 of the cardiac clips worldwide, which can be placed while the patient is undergoing open heart surgery for a separate procedure.
The implant, which Medtronic acquired that year from the medical device incubator Syntheon, comes pre-loaded in a single-use delivery system that also allows the clip to be recaptured and repositioned.
Cardiac care guidelines recommend that patients with afib undergoing a concomitant surgery should have their left atrial appendage closed—either with specialized hardware, or the excision and placement of sutures by the surgeon’s hand—as the small pocket in the heart wall can be a primary source of stroke-causing blood clots.
New left atrial appendage devices—employing a number of different methods—have been pursued by major medtechs in recent years. As diagnoses of afib continue to increase across an aging population, estimates have predicted the market will reach nearly $6 billion in the year 2030.
Currently, the sector is largely dominated by Boston Scientific, with its Watchman implant, and Abbott’s Amplatzer Amulet; both catheter-based implants that expand within the pocket to seal it off and block the flow of blood. In open surgery, AtriCure provides the AtriClip Pro line of devices. The company announced earlier this year that it had received FDA clearance and conducted its first deployments of the smaller-profile AtriClip Pro-Mini.
And around the same time that Medtronic announced its Penditure acquisition, Johnson & Johnson MedTech touted its $400 million purchase of Laminar—with its minimally invasive approach that twists in a circle from within the pouch, to gather up the tissue and hold it shut. J&J began enrolling a pivotal trial of that device in 2024.
More recently, Boston Scientific is planning an update to its Watchman platform, which saw its last FDA approval in 2023. According to a report from MedTech Dive, the company plans to launch a clinical trial next year with a market rollout slated for late 2027 or early 2028.
Boston Scientific has also been working to tie the use of Watchman to the commercial success of its Farapulse pulsed field ablation platform for afib, combining both devices into a single stroke-reducing procedure.