NovoStent completes enrollment for its SAMBA Stent and Delivery System trial

NovoStent Corporation, a privately held medical device company, today announced the completion of enrollment earlier this summer in 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 has a unique combination of strength, flexibility and vessel coverage that was designed to treat the highly varied presentation of atherosclerotic disease in the superficial femoral and popliteal arteries. Early performance has been encouraging. 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.

“I was impressed by the absence of stent recoil even in highly calcified, eccentric lesions,” said Professor Dr. Thomas Zeller, the Director of the Department of Vascular Medicine at the Herz-Zentrum in Bad Krozingen, Germany where the first implants were performed.

Dr. Sven Braunlich, Angiologist at Park Krankenhaus in Leipzig, Germany, implanted the most devices. He commented, “The stent is very flexible and conforms well to the vessel giving a final angiographic result that resembles the natural vessel.”

NovoStent has developed a novel, self-expanding helical stent technology to provide a wide range of vascular therapies. The treatment of femoropopliteal disease is the first vascular application of NovoStent’s technology. “The SAMBA Stent exceeds the competition in testing for flexibility and strength and we are excited to see these bench tests validated by the impressive acute results and follow-up to date,” said G. Ray Martin, PhD, President and CEO of NovoStent. Dr. Martin added, “With the ability to deliver a nitinol device with over 50% metal surface area, NovoStent has created a new category of vascular device, one that provides the ease of use of traditional slotted tube stents but is designed to provide a substantial barrier against the underlying disease.”

The SAMBA Stent demonstrates the advantages of NovoStent’s alternating helix platform, utilizing ultra-thin stent struts, eliminating the compromises one must make with traditional slotted tube stents and enabling a wide range of applications. NovoStent is advancing its novel technology into other disease states and anatomies such as aneurysm exclusion and small vessel disease.

The company’s stents employ a helical macro structure to maximize flexibility, durability, and radial strength in addition to 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.

www.novostent.com