At the Leipzig Interventional Course (LINC) in Leipzig, Germany, physicians from the United States and Europe presented data on their clinical experience with the IDEV Technologies Supera@ stent. LINC is a meeting forum of global interdisciplinary physicians focusing on endovascular peripheral interventional treatments.
Results on over 1,000 treated patients were compiled and presented, including findings from these four new studies: Supera Interwoven Nitinol Stent Outcomes in Above-Knee interventions (SAKE) study from the Deborah Heart and Lung Center, Brown Hills, NJ; Antwerp Supera in Popliteal & Superficial Femoral Artery (AURORAA) study from Vascular Clinik ZNA, Antwerp, Belgium; Real World experience with the Supera stent in the SFA and Popliteal arteries from Tucson Medical Center, Tucson, AZ; and IDEV Supera Stenting to Preserve Dialysis Access from Lawrenceville, GA.
"All data presented at LINC represents a broad range of patients affected by peripheral vascular disease in the popliteal and SFA arteries, and dialysis fistulas," noted Dennis Donohoe, MD, Chief Medical Officer for IDEV Technologies, Inc., manufacturer of the Supera stent. "These are real-world patients with advanced complex disease, the type that confronts physicians on a daily basis." The primary clinical outcome of two of these 4 new studies was primary patency demonstrating independent, consistent and impressive 1-year primary patency results of 86% (AURORAA) and 88% (Real World, Tucson) with the third study SAKE, producing a 92% Freedom from Target Lesion Revascularization (TLR). These individual study results are consistent with the results reported last October at VIVA on IDEV's SUPERB IDE trial of 264 patients (86% patency at one year by duplex ultrasound, the highest reported patency in an SFA IDE trial) and the Supera 500, a 495 patient study presented by Professor Dierk Scheinert, MD (84% patency rate at 1 year with duplex ultrasound). In addition, the Supera stent was implanted in a number of live cases during LINC.
"These new findings provide additional evidence to suggest the vascular mimetic properties of the Supera stent provide an excellent therapeutic option for physicians treating peripheral vascular disease," said Christopher Owens, president and CEO of IDEV. "In addition, we are encouraged to see our platform technology being utilized in new clinical applications showing promising results for dialysis access patients." Details on the specific LINC sessions featuring information on the Supera Peripheral Stent System can be found on the company website.
The company is also participating in the technical exhibit portion at LINC from January 23-26, 2013.
About the SUPERA Stent The Supera stent is engineered with proprietary interwoven wire technology that mimics vascular anatomy. It is currently indicated in the United States for the palliative treatment of biliary strictures produced by malignant neoplasms and in multiple other countries for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty (PTA).
The SUPERB Trial (Comparison of the SUperaPERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) is an IDE trial to evaluate Supera in treating patients with obstructive superficial femoral artery (SFA) and proximal popliteal artery disease.
About IDEV Technologies, Inc. IDEV is a developer of endovascular technologies designed to protect and restore anatomical function. The Company is focused on redefining the endovascular treatment paradigm by providing physicians and patients with a new standard of technologies that deliver clinical excellence. For more information, please visit www.idevmd.com.
Contact: Trent Reutiman Global Vice President of Commercial Operations IDEV Technologies, Incorporated (281) 525-2000 SOURCE IDEV Technologies, Inc.
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