NovoStent Completes Enrollment In SAMBA Femoropopliteal Trial

NovoStent has completed enrollment in the European clinical trial evaluating the use of SAMBATM Stent and Delivery System in the treatment of superficial femoral and popliteal artery disease.

The company claims that the 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.

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.

Reportedly, 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 maximise flexibility, durability, and radial strength in addition to a micro cell structure that can be tailored for different vascular anatomies. NovoStent’s stent and integrated delivery system is designed to provide easy deployment and accurate delivery.

G Ray Martin, president and CEO of NovoStent, said: “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. 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.”