New Class of Endovascular Implant Receives CE Mark
March 2, 2010 — A new stent and delivery system for the treatment of peripheral artery disease (PAD) received CE mark approval this week.
The SAMBA Stent and delivery system 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 strength, flexibility and vessel coverage.
CE mark approval was supported by data from NovoStent’s SAMBA trial which enrolled patients in Germany in 2009. Partial six-month results of the SAMBA trial were presented in January at the International Symposium on Endovascular Therapy by Michael Dake, M.D., of the Stanford University School of Medicine. 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.
The stent features NovoStent's novel, self-expanding alternating helix technology. The SAMBA stent provides over 50 percent vessel coverage, more than twice that of slotted tube stents.
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 preclinical or clinical trials.
The company said the SAMBA Stent creates a new product category that combines the best attributes of stent-grafts and conventional stents. With more than 50 percent metal coverage, the SAMBA has the ability to hold back more disease than a conventional stent. But unlike a stent-graft, patency of side branch arteries can be maintained.
The company’s stents employ an ultra-thin helical macro structure with enhanced flexibility and radial strength along with 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.
Approximately 12 million Americans are afflicted with PAD.
For more information: www.novostent.com