LAA Closure Devices At The Tipping Point
Since the FDA approval of Boston Scientific Corp.'s WATCHMAN device in March, the US market for left atrial appendage closure devices has reached a tipping point. With first-to-market advantage in the US, and a four- to five-year lead on the competition in bringing a LAAC device to the US market, BSX is well positioned to gain a strong foothold in this potentially billion dollar plus market; however, several factors will dictate market adoption of these devices in the US, including reimbursement, clinical efficacy, cost and ease of use.
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The final follow-up data from the CAP and CAP2 registries support left-atrial appendage closure with Watchman as an alternative to long-term anticoagulation in patients with nonvalvular atrial fibrillation.
An analysis of pooled five-year data from the PROTECT AF and PREVAIL trials, show left-atrial appendage closure to prevent stroke in patients with atrial fibrillation is not only cost‐effective compared to treatment with warfarin and other anticoagulant drugs, but saves money over time.
CMS granted national coverage for left atrial appendage closure procedures to prevent stroke under more favorable conditions than what the Medicare agency had proposed in November. This is good news for Boston Scientific, which is ramping up marketing of its Watchman device.