Dive Brief:
- Edwards Lifesciences on Friday received Food and Drug Administration clearance for the Ecliptis left atrial appendage exclusion system, an entry in the FDA’s 510(k) database shows.
- The implantable clip is intended to close the left atrial appendage, or LAA, a small pouch-like structure in the heart's left atrium, to prevent blood clots from forming that can lead to stroke.
- The Edwards device is positioned to compete directly with AtriCure's AtriClip platform and Medtronic's Penditure system, BTIG analyst Marie Thibault told clients in a note Monday. Boston Scientific and Abbott sell LAA occlusion devices that are implanted in minimally invasive procedures.
Dive Insight:
In patients with atrial fibrillation, the inefficient pumping of the heart can cause blood to pool and form clots within the LAA. Because many people with AFib do not tolerate blood thinners well, a procedure-based treatment to close the LAA offers another way to reduce stroke risk.
Medtronic launched the Penditure LAA exclusion system in the U.S. in November 2023, bringing competition to AtriCure. Medtronic acquired the Penditure device from medical device incubator Syntheon in August 2023.
Thibault noted that AtriClip, having already demonstrated the ability to fend off a surgical valve incumbent, should be “well positioned to hold its ground” as a new competitor enters the market. The LAA clip market continued to grow at a fast pace during the Medtronic launch, the analyst said.
Edwards CEO Bernard Zovighian, on a February earnings call, said left atrial appendage closure represented a new therapeutic area for the company that complements specific valve procedures. He said Edwards planned a preliminary introduction of its new surgical LAAC technology later this year.
Edwards’ Ecliptis device is applied during a related cardiac surgery procedure, according to the FDA’s database entry.
“We anticipate a measured, targeted rollout, with [Edwards] leveraging its established surgical valve infrastructure and relationships as the commercial foundation,” Thibault wrote.
