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May 8, 2020

PINNACLE FLX 12-Month Data Reported for Boston Scientific's Watchman FLX LAAC Device

May 8, 2020—Boston Scientific Corporation announced that 12-month results from the PINNACLE FLX clinical trial were presented as a late-breaking clinical trial at HRS 2020 Science, the annual Heart Rhythm Society Scientific Sessions being held as a virtual conference because of the COVID-19 pandemic.

According to the company, the PINNACLE FLX is assessing the safety and efficacy of the company's next-generation Watchman FLX left atrial appendage closure (LAAC) device for patients with nonvalvular atrial fibrillation (NVAF).

The study evaluated the performance of the Watchman FLX device as an alternative to oral anticoagulation therapy, including nonvitamin K antagonist oral anticoagulants (NOACs), for stroke risk reduction in patients with NVAF. The prospective, nonrandomized PINNACLE FLX trial included 400 patients in the United States with NVAF who were eligible for anticoagulation therapy to reduce the risk of stroke but had an appropriate rationale to seek a nonpharmaceutical alternative.

Boston Scientific reported that the trial achieved the following:

  • Primary safety endpoint was met with a low adverse event rate of 0.5%. The safety endpoint was defined as the occurrence of a major procedure-related complication within 7 days after the procedure or time of hospital discharge, whichever was later.
  • Primary effectiveness endpoint was met with a 100% rate of effective LAAC at 12 months postprocedure with peridevice flow ≤ 5 mm.
  • Implant success rate was 98.8%.
  • No patients experienced periprocedural death, device embolization, or pericardial effusion requiring cardiac surgery, all of which are favorable in the context of previous clinical studies.
  • Oral anticoagulation was discontinued in 96.2% of patients after the 45-day follow-up.

Secondary endpoints from the PINNACLE FLX study, including the occurrence of ischemic stroke or systemic embolism, will be reported after 24 months of patient follow-up.

Shephal Doshi, MD, who is a cardiologist at Pacific Heart Institute at Providence St. John's Health Center, California, is coprincipal investigator of the study.

"We believe the next-generation Watchman FLX technology contributed to the excellent overall clinical performance seen in this study, notably the very low rate of safety events and high rate of effective closure," commented Dr. Doshi, in the company's announcement. "In fact, we saw that 90% of patients showed absolutely no detectable leakage around the device at their 12-month follow-up, which compares favorably to the rates of peridevice flow observed in the PROTECT-AF and PREVAIL trials with the predicate Watchman device and may translate into improved long-term clinical outcomes."

In the United States, the next-generation Watchman FLX is an investigational device and not commercially available. It received European CE Mark approval in March 2019. The Watchman FLX is available in broader size options to treat a wide range of patient anatomies. The device is designed to advance procedural performance and safety while expanding the treatable population of patients with NVAF.

Boston Scientific advised that it plans to further evaluate the Watchman FLX device for patients with NVAF via continued enrollment in the ongoing OPTION trial, which is comparing the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure. The CHAMPION-AF clinical trial will study a broader anticoagulant-eligible patient population to evaluate the device against NOACs for embolic stroke prevention.

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