|The second-generation Watchman FLX implant--Courtesy of Boston Scientific|
On the heels of a reimbursement setback in the U.S., Boston Scientific ($BSX) 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.
Just around the time of the CMS decision, the FDA revealed a Boston Scientific field notice to cardiologists designed to guard against undesired blood leakage during the implantation procedure. The notice does not require the return of any of the 29,169 units affected across the globe, but it does highlight the safety concerns stemming from the Watchman's difficult transcatheter implantation procedures that led the FDA to reject or delay the device's approval in 2010 or 2014.
The bad news overshadowed a positive study result presented at the American Heart Association meeting in Orlando, FL. The European Evolution post-approval study of the first-generation Watchman found a 2.8% 30-day serious adverse event rate, lower than that during the device's randomized pivotal trial for FDA approval, TCTMD reported. This suggests cardiologists are moving up the learning curve when it comes to implantation.
Meanwhile, there is a belief on Wall Street that CMS' reimbursement decision will deter St. Jude Medical from trying to bring its CE-marked Amplatzer Amulet left atrial appendage occlusion device to the U.S.
"We remain in discussions with the FDA to assess and evaluate potential IDE clinical trial designs for our LAA closure products in the U.S., and hope to provide additional updates in the near future," said St. Jude spokeswoman Laurel Hood in an email to FierceMedicalDevices.
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