Biosensors International (PINK:BSNRY) said it won a green light from European regulators for its BioMatrix NeoFlex drug-eluting stent, the latest in its DES line.
The Singapore-based medical device company used final 5-year data from its Leaders study, which looked at NeoFlex’s predecessor product, the BioMatrix Flex. The company is touting NeoFlex as the same device but with improved delivery.
"CE Mark approval for BioMatrix NeoFlex represents another important step forward for the BioMatrix brand, improving our flagship product yet further with enhanced deliverability" Jeffrey Jump, president of the cardiovascular division, said in prepared remarks.
Earlier this year, the company won CE Mark approval for its BioFreedom polymer-free drug-eluting stent. According to a 2012 Transcatheter Cardiovascular Therapeutics report, drug-eluting stents demonstrate better safety and efficacy over their bare metal stent counterparts.