Medtronic (NYSE: MDT) announced today that it received CE mark approval for its Penditure LAA exclusion system.
The company plans to begin the European launch of the left atrial appendage (LAA) exclusion device at the 39th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting from October 8-11 in Copenhagen, Denmark. This regulatory milestone comes shortly after the device surpassed 10,000 clips sold globally.
Penditure, an implantable clip, comes pre-loaded on a single-use delivery system for use in LAA management during concomitant cardiac surgery procedures. Medtronic — one of the largest medtech companies in the world — 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, putting more control in the hands of surgeons.
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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.
“Clinicians expect more from Medtronic and we are uniquely positioned to meet these needs to better serve their patients,” said Dr. Pieter Kappetein, chief medical officer, Cardiac Surgery, Medtronic. “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. Surgeons can place the Penditure LAA exclusion system confidently while having the added benefit of recapturability after initial deployment if needed.”
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. However, Medtronic threw its hat in the ring with its Penditure launch a couple of years ago, causing worry among AtriCure investors, as AtriCure develops its own LAAC device — the AtriClip.
Meanwhile, Johnson & Johnson made its own LAA play 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 is another company to keep an eye on with its novel CLAAS device.
