Biosensors receives CE mark approval for BioMatrix NeoFlex


BioMatrix NeoFlex, according to the company, has received the CE mark and features a new advanced stent delivery system to improve pushability, trackability and crossability. It also has a lower lesion entry profile than its predecessor. BioMatrix NeoFlex retains the same combination of abluminal biodegradable polymer coating, proprietary limus drug Biolimus A9 (BA9).

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.