Boston Scientific announced that it has received a CE mark for the second-generation Watchman FLX implant to prevent stroke by plugging the heart's left atrial appendage.The approval enables commercialization in Europe and other countries that accept the CE mark. Boston Scientific said it will be more widely available in EU countries in the first half of 2016; it is currently in a limited market release. According to the product website, there are trained implanters of the device in Italy, Spain, the United Kingdom, Ireland and Denmark.Several European doctors implanted the second-generation Watchman FLX last week, Boston Scientific said in a statement. Among them was Dr. Horst Sievert, of the Cedars-Sinai Heart Institute in Izola, Slovenia."The closed-end design of the Watchman FLX device and the ability to fully recapture and reposition this device make it a very promising option for treating indicated patients with simple to the most complex anatomies," he said in a statement. "With nearly a decade of experience implanting the original Watchman device, it has been exciting to see the advancements of this technology from Boston Scientific and take part in the first implants of this device in Europe."Recapturable and repositionable devices give the cardiologist more flexibility when the device isn't optimally placed during the first attempt at installation in the body. In addition, the FLX's metallic body extends to both sides of the implant. In the original Watchman, the side facing the inside of the left atrial appendage is open.The first-generation Watchman is available in the U.S., where the device was approved by the FDA after regulatory setbacks that kept it from crossing the Atlantic for 10 years following CE marking in 2005.The Centers for Medicare & Medicaid Services recently sent Boston Scientific stock down 4% by proposing to reimburse the first-generation Watchman under the agency's Coverage with Evidence Policy. As such, the decision was expected, but CMS' plan to only cover patients who are contraindicated for the blood thinner warfarin was a surprise because the FDA's label specifically allows implantation in such patients.Luckily for Boston Scientific, the CMS decision is only a proposal, and the company will surely be in discussions with CMS, which will issue a final decision in little less than three months, or 60 days after the conclusion of the 30-day public comment period. A strict interpretation of the contraindication that bars reimbursement in all but those medically ineligible for the drug would be a big blow, while a subjective interpretation that allows coverage of those who are noncompliant or refuse to take the drug would be only a minor setback.After all, the Watchman franchise is designed to offer a mechanical alternative to warfarin, which puts patients at increased risk of uncontrolled bleeding. But the advent of new blood-thinning drugs that compete with warfarin weakens the Watchman's positioning as a second option.About the WATCHMAN FLX LAAC DeviceThe WATCHMAN FLX LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF. The LAA is a thin, sac-like appendix arising from the heart and is believed to be the source of >90% of stroke-causing clots that come from the left atrium in people with non-valvular AF. Images of the WATCHMAN Device and the WATCHMAN FLX Device are available at http://news.bostonscientific.com/image-gallery.About Boston ScientificBoston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare.