NovoStent’s 6-Month Femoropopliteal Trial Results Presented for Samba Stent
May 25, 2010—NovoStent Corporation (Mountain View, CA) announced the 6-month results of a European clinical trial evaluating the use of its Samba stent and delivery system to treat superficial femoral artery (SFA) and popliteal artery disease. Professor Thomas Zeller, MD, presented the 6-month follow-up data at the EuroPCR 2010 conference in Paris. The data showed a 97% freedom from target lesion revascularization rate. There were no device-related complications in any of the 38 patients treated.
“For this initial experience, we evaluated the device in a very challenging group of patients,” commented Dr. Zeller. “The acute safety results were excellent, and the 6-month data are encouraging, with only one reintervention that was performed with a relatively easy angioplasty procedure. With its unique high metal–area design, the Samba stent may act as a barrier to disease unlike any stent on the market today.”
Stent patency was evaluated using color-duplex ultrasound, which showed that patency was maintained in 85% of patients. Patients whose color-duplex ultrasound measurement showed a patency failure maintained their clinical improvement with Rutherford-Becker scores of 0. The most common Rutherford score in all patients at 6-month follow-up was 0. There were no stent fractures in the trial.
NovoStent noted that the SAMBA trial enrolled a challenging patient cohort. 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. Two-thirds of the lesions treated had moderate-to-severe levels of calcium, and the majority of cases treated disease located in the distal SFA or popliteal artery. The company stated that these data confirm that an endovascular implant with more than 50% metal surface area can be safely used to treat atherosclerotic disease and suggest that other areas of investigation may include aneurysm exclusion and drug delivery.
According to NovoStent, the Samba stent provides over 50% vessel coverage, more than twice that of traditional commercially available peripheral vascular stents, which use axial connectors that can stiffen the device and lead to fracture. NovoStent observed that there have been no instances of stent fracture in any of the company’s preclinical or clinical trials because of the flexible design and absence of axial connectors in the Samba stent. NovoStent further describes its stents as employing "an ultrathin macrostructure that exceeds the flexibility and radial strength of traditional stents along with a micro cell structure that can be tailored for different vascular anatomies."