IDEV Technologies, Incorporated, (IDEV), a developer of products for endovascular interventional use, has enrolled first patient in a multi-center FDA approved SUPERB trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) for SUPERA PERipheral System. SUPERA stent is a self-expanding stent intended for treating biliary and peripheral artery disease (PAD) in the superficial femoral artery (SFA).
The SUPERB is a prospective, single-arm trial with an estimated enrollment of 258 patients at up to 40 US sites. The trial is led by national co-principal investigators Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, and Lawrence A. Garcia, M.D. Chief, Section Interventional Cardiology and Associate Director of Vascular Medicine at Boston’s Caritas St. Elizabeth Medical Center, where the first patient was treated.
The objective of the trial is to demonstrate the safety and effectiveness of the SUPERA stent in the treatment of obstructive arterial disease in the superficial femoral artery of the lower extremity. The SUPERA Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary system received 510(k) clearance for palliative treatment of biliary strictures produced by malignant neoplasms and the SUPERA Interwoven Self-Expanding Nitinol Stent System received CE Mark approval in Europe for biliary and peripheral vascular indications.
“The SUPERA stent has unique properties that may be demonstrated on patients at facilities throughout the US,” said Dr. Rosenfield. “We believe this could prove to offer a significant advance in treating PAD and helping physicians treat the most difficult of blockages in a very large underserved patient population.”
Dr. Garcia added: “Ultimately, through this study, the SUPERA stent could become the new benchmark for stenting infra-inguinal femoral arterial obstructive disease.”
Peter Soukas, M.D., Director of Vascular Medicine and the Vascular Laboratories at St. Elizabeth’s, enrolled and treated the trial’s first patient.
“Our patient had a calcified SFA lesion that was treated thanks to the radial strength and flexibility afforded by the unique woven design of the SUPERA stent,” said Dr. Soukas. “I am confident the stent will demonstrate the same resistance to strut fracture and primary patency that has been seen in Europe.”
IDEV President and Chief Operating Officer Christopher M. Owens called the enrollment of the first patient “a significant milestone for IDEV Technologies and an opportunity to demonstrate the safety and effectiveness of the unique SUPERA design. I’d like to congratulate all the members of our team on our progress to this point.”