Dive Brief:
- Medtronic has received a CE mark for its Penditure left atrial appendage exclusion system, the company said Wednesday.
- Penditure, which Medtronic acquired and launched in the U.S. in 2023, is a clip that surgeons use to close the LAA during cardiac surgeries. The LAA is a source of stroke-causing clots in patients with atrial fibrillation.
- AtriCure provides a rival clip that is also implanted during cardiac surgery. Abbott and Boston Scientific sell LAA occlusion devices that are implanted in minimally invasive procedures.
Dive Insight:
Medtronic added Penditure to its portfolio through the acquisition of Syntheon. The company launched the device in the U.S. shortly after inking the takeover. This week, Medtronic said it has sold more than 10,000 Penditure devices globally.
Penditure is a direct competitor of AtriCure’s AtriClip, which the FDA cleared in 2010. AtriClip and Penditure are used in people who are having cardiac surgery for another reason, differentiating them from Abbott’s Amplatzer Amulet and Boston Scientific’s Watchman.
AtriCure received a CE mark for AtriClip in 2009. The company received CE marks for an updated device and an expanded indication in 2016 and 2024, respectively. International sales of AtriCure’s appendage management products increased 26% over the first six months of the year to hit $20.5 million. U.S. sales of the devices were $87.2 million over the same period.
Medtronic is now positioned to challenge AtriCure in the European Union and other markets that accept CE marks. In the company’s first quarter of fiscal 2026, Medtronic’s most recent set of results, the company cited Penditure as a driver of low-double digit cardiac surgery growth.
The company plans to launch the LAA device in Europe late next week. Medtronic is using the European Association for Cardio-Thoracic Surgery Annual Meeting in Copenhagen, Denmark, to launch the product. The company said Penditure is the only LAA clip that surgeons can recapture, reposition and redeploy after deployment during a procedure.
