IDEV Announces Results from Revascularization with Supera on Real World Patients (RESTORE) Study, Demonstrating Positive Clinical Outcomes in Significantly Diseased Patients with Long Lesions
WEBSTER, Texas, Jan. 31, 2013 /PRNewswire/ — IDEV Technologies, Inc. today announced results from a new study by physicians from Tucson, Arizona, which were reported at last week’s LINC meeting in Leipzig, Germany. The data matched previously reported results with the Supera® Stent in other studies, but in a group of patients with more advanced peripheral disease.
One hundred forty-seven patients from Tucson were included in the analysis. Long lesions were studied, with the mean lesion length of their superficial femoral artery (SFA) and popliteal artery disease of 18.4 cm, which was treated by an average stent length of 19.7 cm. The study included patients with TASC II C & D disease (28 and 33% respectively). In addition, 35% of the patients had tissue loss and were accounted for via Rutherford Becker 5 & 6 classification, and 53% of all patients had chronic total occlusions (CTO). The overall primary patency rate, measured by duplex ultrasound, at one year follow-up was 88%. Zero fractures were found within a subgroup analysis of 47 patients which received follow-up x-ray evaluation.
“Our experience included patients with a significant burden of disease,” commented John Pacanowski, MD, Chief of Vascular Surgery, Tucson Medical Center. Based on the broad in-depth overall volume of data for Supera, combined with the results from our study, we believe Supera could become the stent of choice for long and calcified lesions and the primary device for highly diseased patients. Dr. Pacanowski also noted the vascular mimetic stent (VMS) design of Supera may better serve these type of anatomy, which are characterized by a location and disease state that are subject to extreme mechanical stresses.
“We are pleased to see impressive results like these in this type of challenging patient cohort,” confirmed Chris Owens, President and CEO of IDEV Technologies. “It is encouraging that physicians are continuing to reproduce positive results such as those reported earlier in European studies, even when Supera is utilized across a broad range of disease states, operators, various studies and clinical sites.”
About the Supera Stent
The Supera stent is engineered with proprietary interwoven wire technology that mimics vascular anatomy. It is currently indicated in the U.S. 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).
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.