Penditure, an implantable chip, comes pre-loaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures. Medtronic designed it with a curve to better match atrial anatomy and without fabric for atraumatic closure and reduced inflammation. The company acquired the device from Syntheon in August of this year. It received FDA clearance that same month and is available in the U.S. on a limited basis.
The medtech giant says its device is the only LAA clip that can be recaptured, repositioned and redeployed after deployment during a procedure. This puts greater control in the hands of surgeons. Noteworthy competitors in the space include Abbott’s Amplatzer Amulet, Boston Scientific’s Watchman and AtriCure’s AtriClip.
“The strategic addition of the Penditure Left Atrial Appendage Exclusion System demonstrates our commitment to investing in cardiac surgeons and their growing needs for managing patients with more complex cardiac disease. 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,” said Karim Bandali, PhD, president of the Cardiac Surgery business within the Cardiovascular Portfolio at Medtronic.
Initial cases kick off Medtronic Penditure launch
Medtronic said the launch of Penditure expands its Cardiac Surgery product portfolio to include LAA management. Dr. Gorav Ailawadi and Dr. Basel Ramlawi performed the first cases with the device to mark the launch. They performed them at the University of Michigan Frankel Cardiovascular Center and Lankenau Heart Institute, respectively.
Ailawadi said the launch “brings innovation to the space” and offers a low-profile solution that can provide control and visibility.
“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,” Ailawadi noted.
Ramlawi said the device demonstrated effectiveness in completely excluding the LAA at its base. The doctor noted “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,” Ramlawi said.
Medtronic plans to begin enrollment in a post-market study early next year. It plans to further evaluate the performance and clinical outcomes of Penditure in those undergoing concomitant cardiac surgery. The company expects the multi-center, single-arm, non-randomized study to enroll around 150 patients across 25 U.S. sites.
