Biosensors International has announced CE Mark approval for BioMatrix NeoFlex™, the latest addition to the BioMatrix family of drug-eluting stents (DES).
Background
Singapore-based Biosensors says its NeoFlex stent features a new advanced 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 the company says has made the BioMatrix stent family an increasingly popular choice of DES in the global markets where it is available.
BioMatrix NeoFlex possess all the attributes of its successful predecessor, combined with enhanced 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™.
BioMatrix NeoFlex will be rolled out in all CE Mark global markets over the coming months.
Company comments
“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.”
Source: Biosensors International
published: May 20, 2013 in: Approval/Clearance, Cardio