NovoStent has received CE mark for its Samba stent and delivery system for the treatment of peripheral artery disease. It was designed to treat atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a combination of strength, flexibility and vessel coverage.
The CE mark approval was supported by data from NovoStent’s Samba trial which enrolled patients in Germany in 2009. The company claimed that the Samba Stent provides over 50% vessel coverage, more than twice that of slotted tube stents offered by such renowned medical device companies as Johnson & Johnson (JNJ), Abbott Laboratories (ABT), Boston Scientific (BSX) and Medtronic (MDT).
Due to the absence of axial connectors and flexible design, there have been no instances of stent fracture in any of the company’s pre-clinical or clinical trials.
NovoStent’s stents employ an ultra-thin helical macro structure that exceeds the flexibility and radial strength of traditional stents along with a micro cell structure that can be tailored for different vascular anatomies. NovoStent’s stent and integrated delivery system is designed to provide easy deployment and accurate delivery.
Ray Martin, president and CEO of NovoStent, said: “We are extremely pleased with this approval and our ability now to offer a product that can treat just about any disease presentation in the SFA and popliteal artery. Our Samba Stent is creating an entirely new product category that combines the best attributes of stent-grafts and conventional stents.
“With over 50% metal coverage, the Samba Stent has the ability to hold back more disease than a conventional stent. But unlike a stent-graft, patency of side branch arteries can be maintained.”