NovoStent's Samba Receives CE Mark to Treat SFA Disease

March 1, 2010—NovoStent Corporation (Mountain View, CA) announced that it has received CE Mark approval for its Samba stent and delivery system for treating peripheral arterial disease. The Samba stent was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral and popliteal arteries.

According to the company, CE Mark approval was supported by data from NovoStent's SAMBA trial that enrolled patients in Germany in 2009. Michael Dake, MD, presented partial 6-month results of the SAMBA trial at the International Symposium on Endovascular Therapy, which convened in Hollywood, Florida on January 17–21. 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 in which interventionists typically avoid placing stents because of the possibility of stent fracture.

NovoStent features a self-expanding alternating helix technology that provides > 50% vessel coverage. The company stated that because of the absence of axial connectors and its flexible design, there have been no instances of stent fracture in any of the company's preclinical or clinical trials. NovoStent's stents employ an ultrathin helical macrostructure to provide flexibility and radial strength and a microcell structure that can be tailored for different vascular anatomies, the company stated.