Boston Scientific completes enrolment for new Watchman trial
3 July 2012 16:38 in Medical Company Product News
Boston Scientific has announced the completion of enrolment for a new clinical study of Watchman, a left atrial appendage closure device that is available in 30 countries.
The prospective randomised Prevail trial has enrolled 407 patients at 42 sites and is comparing the Watchman device to warfarin in high-risk patients with atrial fibrillation eligible for long-term warfarin therapy.
Watchman is already the most widely-studied medical device of its kind, with the latest trial designed to gain US Food and Drug Administration approval of the product.
To date, it has been studied in more than 2,000 patients, exceeding 4,000 patient-years of follow-up.
Dr Kenneth Stein, chief medical officer of Boston Scientific's cardiac rhythm management group, said: "Enrolment completion of the Prevail study is a significant milestone in helping to bring this innovative therapy to patients living with atrial fibrillation in the US."
Last month, the company announced the sale of its benign prostatic hyperplasia treatment business Prolieve to Medifocus, the technology's original creator.
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