At the Society of Thoracic Surgeons annual meeting in New Orleans, investigators shared results from the exClusion of the Left atrIal appendage with PendITure (CLIP-IT) post-market study. The study collects evidence on the performance and clinical outcomes of the Penditure LAA exclusion system in concomitant cardiac surgery.
Penditure, an implantable clip, comes pre-loaded on a single-use delivery system for use in LAA management during concomitant cardiac surgery procedures. Medtronic designed Penditure with a curve to better match the atrial anatomy. It also has no fabric to reduce the risk of inflammation.
The company says Penditure is the only LAA clip on the market today that can be recaptured, repositioned and redeployed after deployment during a procedure. It aims to put more control in the hands of surgeons.
Medtronic acquired the device from Syntheon in August of 2023. It received FDA clearance that same month and the company launched it in November 2023. The company also picked up CE mark for Penditure last fall.
The LAA space remains an interesting one to watch. Boston Scientific offers the Watchman system that currently mainly competes against offerings like Abbott’s Amplatzer Amulet. Medtronic threw its hat in the ring with Penditure, leading causing worry among AtriCure investors, as AtriCure develops its own AtriClip LAA device.
Johnson & Johnson Medtech entered the fray late in 2023 with the $400 million acquisition of Laminar. Laminar’s LAA device aims to eliminate the appendage to treat AFib completely. Conformal Medical, set to be acquired by Gore, also offers competition with its novel CLAAS device.
More on the CLIP-IT findings from Medtronic
CLIP-IT evaluated implantations in 150 patients across 15 U.S. clinical sites, generating data on Penditure following its domestic rollout.
Primary results included a 100% rate of successful exclusion of the LAA from the heart. Investigators defined this as the absence of residual communication between the left atrium (LA) and the LAA per 3-month CT).
CLIP-IT also had a 0% composite rate of device-related serious adverse cardiac events at 30 days post-procedure. Investigators reported a 100% recapture and redeployment of the clip in procedures using the clip recapture feature. The study achieved acute electrical isolation of the LAA in 100% of patients in the evaluated subset.
“The outcomes and findings from CLIP-IT further strengthen confidence in the device and support the experience we are seeing in real-world practice,” said Dr. Gorav Ailawadi, professor of surgery at the University of Michigan and investigator in the CLIP-IT study.
Medtronic said the findings support the consistent performance of the Penditure LAA system across key procedural and clinical endpoints.
“Medtronic remains fully committed to developing clinical evidence critical to scientific advancement and medical practice that also has a significant, positive impact on patients’ lives,” said Eric Klavetter, VPof Clinical Research and Medical Science for the Cardiac Surgery business at Medtronic. “Our goal is to empower clinicians to perform procedures with confidence, precision, and consistency, ultimately helping them achieve the best possible outcomes for their patients.”
