Late-Breaking Trial Data at TVT Demonstrate Sustained Safety and Performance of WATCHMAN FLX™ Left Atrial Appendage Closure Device

WATCHMAN FLX™ Left Atrial Appendage Closure Device Update

Today, Boston Scientific (NYSE: BSX) announced positive 24-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation (NVAF). Presented as late-breaking clinical science at TVT: The Structural Heart Summit, the study evaluated the WATCHMAN FLX device as an alternative to long-term oral anticoagulation therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), for stroke risk reduction in patients with NVAF.

Boston Scientific, Watchman Flx™

The prospective, non-randomized PINNACLE FLX trial included 400 patients in the U.S. with NVAF who were eligible for anti-coagulation therapy to reduce the risk of stroke but had appropriate rationale to seek a non-pharmaceutical alternative. Following the positive 12-month results in which the trial met its primary safety and efficacy endpoints, the trial met its secondary effectiveness endpoint – defined as the occurrence of ischemic stroke or systemic embolism over 24 months – with a rate of 3.4% compared to the performance goal of 8.7%.[i]

“These findings demonstrate sustained device performance over two years and reinforce the excellent safety and efficacy profile of the WATCHMAN FLX technology,” said Saibal Kar, M.D., study co-principal investigator and interventional cardiologist at Los Robles Regional Medical Center and Bakersfield Heart Hospital, California. “Building upon the low complication rates and 100% rate of effective LAA closure seen at 12 months, the 3.4% rate of ischemic stroke and systemic embolism at 24 months is very encouraging in this complex, elderly patient population.”

In addition to the low rate of ischemic stroke, the data through 24 months also demonstrated that no patients experienced a device embolization or pericardial effusion requiring cardiac surgery, all of which is favorable in the context of previous clinical studies.[ii]

“The final results of this pivotal study underscore how design advancements of the WATCHMAN FLX device – which allow for improved anchoring, a faster, more effective LAA closure and compatibility with more complex anatomies – have translated into a safe, effective and durable option for patients with NVAF at increased risk for stroke and systemic embolism and an appropriate rationale to seek a non-pharmaceutical alternative,” said Dr. Ian Meredith, AM, global chief medical officer, Boston Scientific.

The next-generation WATCHMAN FLX device received U.S. Food and Drug Administration (FDA) approval in July 2020 and CE Mark in March 2019, and is now used in nearly all implants in the U.S. and Europe in lieu of the previous-generation device.

The company continues its clinical research on the WATCHMAN FLX device for use in patients with NVAF via two large prospective, randomized controlled trials: the OPTION trial – comparing the WATCHMAN FLX device to oral anticoagulants in patients who also undergo a cardiac ablation procedure; and the CHAMPION-AF clinical trial – studying a broader anticoagulant-eligible patient population to evaluate the device against NOACs for embolic stroke prevention.

For more information on the WATCHMAN FLX device, visit www.watchman.com/implanter.

Hot this week

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”

Avery Dennison Medical Introduces Ipdated SilFoam Lite: Sustainability, MDR Certification & Performance Improvements

The newly enhanced SilFoam Lite delivers superior efficiency and reliability, bringing improved fluid handling capabilities and improved tack. These improvements make the product ideal for customers seeking quality, high-performance solutions in wound care notes Avery Dennison Medical.

Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump

Medtronic Expands AiBLE Spine Surgery Ecosystem with New Technologies and Siemens Healthineers Partnership

New advancements in the AiBLE Spine Surgery ecosystem build upon the company's commitment to procedural innovation and execution