Medical tech giant Boston Scientific Corporation (BSX) has announced that it has received U.S. Food and Drug Administration (FDA) approval for its next-generation heart device, the Watchman FLX Left Atrial Appendage Closure (LAAC) Device.
The device is indicated to reduce the risk of stroke in patients with non-valvular atrial fibrillation (NVAF) who need an alternative to oral anticoagulation therapy by permanently closing off the left atrial appendage – the area of the heart where stroke-causing blood clots commonly form.
According to the company, it is the first LAAC device that can be fully recaptured, repositioned and redeployed for precise placement, with better long-term stability and a faster, more complete seal. It can also treat a wider range of patient anatomies.
“Our WATCHMAN technology was the first FDA-approved LAAC device on the market and has been implanted in more than 100,000 patients worldwide, and now with the WATCHMAN FLX device, we are taking the clinical benefits of the technology to the next level for more patients while further differentiating our structural heart portfolio in the US” commented Joe Fitzgerald, president, Interventional Cardiology, Boston Scientific.
Positive 12-month results for the Watchman FLX device were recently presented as a late-breaking clinical trial at Heart Rhythm Society 2020 Science. The study met its primary safety and efficacy endpoints with a low rate of major procedure-related safety events (0.5% at 7 days post procedure) and high rate of effective LAAC (100% with peri-device flow < 5mm at 12 months post procedure). Data also demonstrated a high implant success rate of 98.8%.
Additional clinical research will now continue via enrollment in the Option trial – comparing the device to oral anticoagulants in patients who also undergo a cardiac ablation procedure – as well as in the Champion-AF trial, which will study a broader patient population.
The company will immediately commence a limited launch of the device in the U.S.
Shares in Boston Scientific rose 2% in Tuesday’s after-hours trading, with the stock currently down 17% on a year-to-date basis. Nonetheless analysts have a bullish Strong Buy consensus on Boston Scientific’s outlook, with an average analyst price target of $44 (17% upside potential). (See Boston Scientific stock analysis on TipRanks).
“BSX’s solid execution on its pipeline and acquisitions have delivered best in class sales growth and helped to diversify the company from slower end markets” commented Oppenheimer analyst Steven Lichtman recently. But he added: “Near-term pressure will be felt down the P&L from COVID-19, though BSX has offsets in its underlying pipeline and high out-patient mix.”
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