Medical device manufacturer Boston Scientific has received CE mark approval for its next generation Watchman FLX left atrial appendage closure (LAAC) device.
The Watchman FLX device is a catheter-delivered heart implant developed to close the LAA to avoid the migration of blood clots from the LAA, allowing to reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF.
The first-generation Watchman device received CE mark approval in 2005 to prevent thrombus embolization from the LAA and reduce the risk of bleeding events in patients with non-valvular atrial fibrillation (AF).
In 2012, the CE mark was expanded to include patients with a contraindication to anticoagulation therapy.
Boston Scientific rhythm management chief medical officer Dr Kenneth Stein said: "The Watchman device is the most studied left atrial appendage closure device and has been used to help reduce the risk of stroke for tens of thousands of high-risk patients with non-valvular atrial fibrillation who seek an alternative to long-term anticoagulant therapy.
"We are pleased that this next-generation technology has been granted European regulatory approval and we can begin a controlled product roll-out to clinicians throughout Europe."
In the US, the Watchman device is indicated to reduce the risk of thromboembolism from the LAA in patients with non-valvular AF.
Currently, Watchman FLX device availability is limited, and will be marketed widely in the EU countries in the first half of 2016. It is not available for sale in the US.
In September this year, Boston Scientific received CE mark approval for its Vercise Primary Cell (PC) Deep Brain Stimulation (DBS) system to treat Parkinson’s disease (PD).