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Arterial stents from Flexible Stenting Solutions are implanted in first-in-man clinical trial

Flexible Stenting Solutions : 11 August, 2008  (Company News)
A physician at Auckland City Hospital in New Zealand has successfully implanted several of Flexible Stenting Solutions’ third generation arterial stents for the treatment of peripheral vascular lesions involving the superficial femoral and popliteal arteries.
Patients with lesion lengths up to 100mm and fully occluded lesions were included in the study.

The first-in-man clinical trial using a full range of Stent sizes, including 120mm, was performed by associate professor Andrew Holden who is the director of interventional radiology at Auckland City Hospital, and the principal investigator. “The flexible Stent handled both stenoses and occlusions in the femoro-popliteal artery segment as well as I had hoped with excellent immediate appearances following deployment” said professor Holden. “Overall, I felt the Stent and delivery system performed very well in the acute phase and I await the longer term follow up in these patients with great interest.

Flexible Stenting Solutions has developed a novel, self-expanding Stent technology to provide a wide range of vascular and non-vascular therapies. The treatment of femoro-popliteal disease is the first vascular application of Flexible Stenting Solutions’ technology.

”We believe the FlexStent represents a true third generation SFA/Pop Stent and delivery system that can significantly improve patient care in the high growth peripheral vascular segment.” said Janet Burpee, chief executive officer of Flexible Stenting Solutions. “Given the results of this study we intend to pursue a comprehensive regulatory and commercial development strategy.”

While Stent procedures have become widespread in the treatment of coronary arterial disease, their use in the more challenging peripheral vascular disease setting had been limited in the last several years by inadequate Stent design. The fully connected SFA/Pop flexible Stent has coupled technology with clinical needs by providing a highly durable and fatigue resistant Stent with superior radial stiffness and low chronic outward force. The delivery system promotes simplicity, ease-of-use and accurate placement for the vascular physician.
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