Biosensors Receives CE Mark Approval for BioMatrix NeoFlex
Biosensors International has announced CE Mark approval for BioMatrix NeoFlex™, the latest addition to the BioMatrix family of drug-eluting stents (DES).
BioMatrix NeoFlex features a new advanced stent delivery system, improving pushability, trackability and crossability. It also has a lower lesion entry profile than its predecessor. BioMatrix NeoFlex retains the same unique combination of abluminal biodegradable polymer coating, proprietary limus drug Biolimus A9™ (BA9™) and flexible platform which has made the BioMatrix stent family an increasingly popular choice of DES in the global markets where it is available.
The landmark LEADERS trial demonstrated the ‘Gold Standard’ performance of BioMatrix Flex™, and the baton has now been passed to the next generation in the form of BioMatrix NeoFlex, equipped with all the attributes of its successful predecessor, together with improved deliverability.
Results from the final five-year LEADERS data, presented at TCT 2012, demonstrated that BioMatrix Flex significantly reduced the risk of clinical events in the very late phase, and showed a significant reduction in very late stent thrombosis (VLST), compared with Cypher® Select™.
“CE Mark approval for BioMatrix NeoFlex represents another important step forward for the BioMatrix brand, improving our flagship product yet further with enhanced deliverability ”, commented Jeffrey B. Jump, President of Biosensors’ Cardiovascular Division. “Since the launch of the original BioMatrix in 2008, we have been the driving force in biodegradable polymer stent technology: BioMatrix NeoFlex will enable us to retain this position.”
BioMatrix NeoFlex will be rolled out in all CE Mark global markets over the coming months.