Medtronic gains key approval for LAA exclusion device
Medtronic has received CE mark approval for its Penditure Left Atrial Appendage (LAA) Exclusion System. The company plans on officially launching the device in Europe at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Denmark.
The device was designed for the exclusion of the LAA in patients undergoing concomitant heart surgeries, a step intended to help reduce their risk of stroke. It arrives pre-loaded on a single-use delivery system.
Medtronic acquired the Penditure technology back in August 2023 from the Syntheon medical device incubator in Florida. It was cleared by the U.S. Food and Drug Administration that same month and then launched as part of the company’s cardiac surgery portfolio.
“The strategic addition of the Penditure LAA Exclusion System demonstrates our commitment to investing in cardiac surgeons and their growing needs for managing patients with more complex cardiac disease,” Giuseppe Savoja, Western Europe senior business director for Medtronic’s cardiac surgery division, said in a statement. “The Penditure device reinforces our commitment to innovation and provides an important, new, differentiated LAA management option for cardiac surgeons in the care of their patients in Western Europe. We are excited to officially launch the Penditure device in the European market and to feature it at our EACTS booth and Medtronic Training Center as well as during the Oct. 9 Medtronic Lunch Symposium for the first time.”
“The Penditure LAA Exclusion System brings innovation to the space, with a wide opening at the base offering good visibility, which may assist in proper clip placement,” added Pieter Kappetein, PhD, MD, Medtronic’s chief medical officer of cardiac surgery. “Surgeons can place the Penditure LAA Exclusion System confidently while having the added benefit of recapturability after initial deployment if needed.”
