6-month results of NovoStent's SAMBA trial for atherosclerotic disease in SFA and popliteal arteries

May 26 2010

NovoStent Corporation, a privately held medical device company, today announced the 6-month follow-up results of the company's European clinical trial evaluating the use of its SAMBA^TM Stent and Delivery System in the treatment of superficial femoral and popliteal 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 increased vessel coverage, strength and flexibility.

“We are very pleased with the 6-month results in the SAMBA trial and how they support the continued positive development of this novel device from design concept to bench and animal testing and now to the initial human experience”

Professor Dr. Thomas Zeller, Director of the Department of Vascular Medicine of the Herz-Zentrum in Bad Krozingen, Germany, presented the 6-month follow-up data in a Late Breaking Clinical Trials session at the EuroPCR conference in Paris, France. The SAMBA data showed a 97% Freedom from Target Lesion Revascularization rate. There were no device related complications in any of the 38 patients treated in the trial. "For this initial experience, we evaluated the device in a very challenging group of patients. 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," said Dr. Zeller. "With its unique high metal area design, the SAMBA Stent may act as a barrier to disease unlike any stent on the market today," he continued.

Stent patency was evaluated non-invasively through the use of color-duplex ultrasound (CDUS). Stent patency was maintained in 85% of patients. Patients whose CDUS measurement showed a patency failure maintained their clinical improvement with Rutherford-Becker scores of 0. In fact the most common Rutherford score in all patients at the 6 month follow up time point was 0. There were no stent fractures in the trial.

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. Physicians typically avoid placing stents in the popliteal artery for fear of stent fracture. 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.

"We are very pleased with the 6-month results in the SAMBA trial and how they support the continued positive development of this novel device from design concept to bench and animal testing and now to the initial human experience," said G. Ray Martin, PhD, President and CEO of NovoStent. "These data confirm that a unique endovascular implant with over 50% metal surface area can be safely used to treat atherosclerotic disease. This opens up exciting new areas for investigation such as aneurysm exclusion and drug delivery."

Timothy Mills, PhD, Chairman of the Board of NovoStent, commented "We are extremely proud of the company's significant clinical achievement and how they have overcome the technical challenges that historically plagued traditional stent designs. It's remarkable to see that a stent with enhanced vessel coverage relative to typical stents can also be significantly thinner, stronger and more flexible." NovoStent has redefined endovascular metallic implants with its novel technology. The SAMBA Stent provides over 50% vessel coverage, more than twice that of typical 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.

The company's stents employ an ultra-thin 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.