LAA exclusion system for use in AF during cardiac surgery cleared, launched in US
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Key takeaways:
- Medtronic announced the launch of its LAA exclusion system in the U.S. after its August 2023 FDA clearance.
- The device is used during cardiac surgery procedures on patients with preoperative atrial fibrillation.
Medtronic announced the U.S. launch of its left atrial appendage exclusion system for use during cardiac surgery in patients with preoperative atrial fibrillation.
In August, the LAA exclusion system (Penditure) received 510(k) clearance from the FDA and Medtronic completed its acquisition of the device’s developer, Syntheon LLC, according to a press release issued by Medtronic.
The device is a preloaded, implantable, curved clip on a single-use delivery system designed for LAA management during concomitant cardiac surgery, according to the release.
The clip is designed without fabric to facilitate atraumatic closure and reduce inflammation and is recapturable, repositionable and can be redeployed during cardiac surgery.
“This launch brings innovation to the space, offering a solution that is low profile and can provide more control and visibility than ever before. And 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,” Gorav Ailawadi, MD, the Helen F. and Marvin M. Kirsh Professor of cardiac surgery and director of the Frankel Cardiovascular Center at the University of Michigan, said in the release.
Enrollment in the postmarket CLIP-IT trial will begin in early 2024 and is designed to evaluate the performance and clinical outcomes of the LAA exclusion system in patients undergoing concomitant cardiac surgery, according to the release.
Reference:
- 510(k) Premarket Notification. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K232295. Published Aug. 30, 2023. Accessed Nov. 27, 2023.
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