FDA approves next-generation LAA closure device for nonvalvular AF
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The FDA has approved a second-generation left atrial appendage closure device for patients with nonvalvular atrial fibrillation, Boston Scientific announced.
The device (Watchman FLX) has been shown to reduce the risk for stroke in patients who require left atrial appendage closure an alternative to oral anticoagulation, the company stated in a press release.
According to the release, the device has a fully rounded design that allows physicians to safely enter and maneuver within the left atrial appendage.
“This approval will give patients access to technology that is designed to more safely and effectively close the left atrial appendage compared to what’s commercially available today,” Shephal Doshi, MD, director of cardiac electrophysiology at Providence Saint John’s Health Center at the Pacific Heart Institute in Santa Monica, California, and principal investigator of the PINNACLE FLX trial, told Healio.
It is the first device of its kind that can be recaptured, repositioned and redeployed, and its frame design contributes to optimal device engagement, the company stated in the release.
The approval was based on positive results from the PINNACLE FLX study presented at the virtual Heart Rhythm Society Annual Scientific Sessions. As Healio previously reported, the primary safety endpoint of all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention at the later of 7 days or hospital discharge occurred in 0.5% of the study population, beating the performance goal of 4.21% (P < .0001). In addition, implantation was successful in 98.8% of patients and the rate of effective left atrial appendage closure at 12 months was 100%.
“We’ve been very pleased with the real-world clinical outcomes and positive physician feedback for the Watchman FLX device in Europe and are excited to extend availability of this next-generation technology to patients and clinicians throughout the U.S.,” Joe Fitzgerald, president of interventional cardiology at Boston Scientific, said in the release. “Our Watchman technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide.”
“By making the appendage closure procedure more safe and effective, patients previously discouraged should be increasingly considered as candidates for therapy,” Doshi said in an interview.
More research on this device will be performed in the OPTION trial and the CHAMPION-AF trial, according to the release. In the OPTION trial, researchers will compare the device to oral anticoagulation in patients who underwent cardiac ablation. The CHAMPION-AF trial will focus on a broader population of patients who are eligible for oral anticoagulation and compare them in a head-to-head fashion with novel oral anticoagulants.
For more information:
Shephal Doshi, MD, can be reached at skdoshi@pacificheart.com.
Perspective
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Daniel J. Cantillon, MD, FACC, FHRS
FDA approval clears the way for physicians like myself, and many others, whom were not involved in the investigational study of Watchman FLX but routinely perform Watchman procedures to ultimately gain access to this system, which can potentially address some of the challenging anatomical configurations not well suited to the first-generation device. Some of my colleagues here at the Cleveland Clinic directly involved in the investigational use of Watchman FLX have experienced overall encouraging early results. Post-approval “real-world” experience in the hands of a larger pool of physician operators will yield additional important clinical data.
This second-generation Watchman device is part of a larger effort to make catheter-based closure of the left atrial appendage easier, safer and available to a greater number of patients as an alternative to long-term oral anticoagulation (blood thinners) as stroke prevention for nonvalvular AF. Other companies have devices and delivery platforms in various stages of development or investigational study designed to ultimately compete with Watchman and Watchman FLX in this regard. Such competition drives iterative improvements, ultimately leading to better patient care solutions.
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