Novostent Corporation Receives CE Mark for New Class of Endovascular Implant
3/1/2010 1:43:45 PM
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--NovoStent® Corporation, a privately held medical device company, today announced that it has received CE Mark for its SAMBATM Stent and Delivery System for the treatment of peripheral artery disease. The SAMBA Stent was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral (SFA) and popliteal arteries by providing a unique combination of strength, flexibility and vessel coverage.
CE Mark approval was supported by data from NovoStent’s SAMBA trial which enrolled patients in Germany in 2009. Partial 6-month results of the SAMBA trial were presented in January at the International Symposium on Endovascular Therapy by Dr. Michael Dake of the Stanford University School of Medicine. Lesions treated in the trial included a wide spectrum of disease such as total occlusions, eccentric calcified plaque, ulcerating lesions and thrombotic occlusions. Also included in the trial were several isolated popliteal lesions. Physicians typically avoid placing stents in the popliteal artery for fear of stent fracture.
NovoStent has redefined endovascular metallic implants with its novel, self-expanding alternating helix technology. 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). Traditional peripheral vascular stents use axial connectors that can stiffen the device and lead to fracture. 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.
“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,” said G. Ray Martin, PhD, President and CEO of NovoStent. Dr. Martin added, “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.”
The company’s stents employ an ultra-thin helical macro structure that greatly 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 unique stent and integrated delivery system is designed to provide easy deployment and accurate delivery.
Approximately 12 million Americans are afflicted with peripheral artery disease (PAD). PAD commonly causes a narrowing or blockage of the leg arteries, which can result in pain when walking or even resting. NovoStent is a pioneering medical device company that seeks to provide options for patients needing treatment for their leg pain.