IDEV's Pivotal SUPERB Trial Demonstrates SUPERA® Stent Significantly Exceeds VIVA Criteria for One-Year Patency in Femoropopliteal Artery Disease
-- Late-Breaking Data Presented at Vascular InterVentional Advances (VIVA) 2012 Conference in Las Vegas --
--Data from SUPERB Trial Support IDEV's PMA Filing with the FDA--
LAS VEGAS and WEBSTER, Texas, Oct. 10, 2012 /PRNewswire/ -- IDEV Technologies, Inc. (IDEV) today announced positive clinical outcomes for its SUPERB pivotal clinical trial of its SUPERA® Peripheral Stent System. This Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial demonstrated the highest patency rates in peripheral stent trials for superficial femoral or proximal popliteal artery disease that has been publically reported. In addition, this is the first and only femoral-popliteal artery IDE trial to record zero stent fractures for nitinol-based technologies. The SUPERA stent is a highly differentiated, disruptive and proprietary interwoven nitinol wire technology platform that offers significantly improved radial strength, flexibility and kink resistance, which is designed to adapt to the anatomy. Kenneth Rosenfield, M.D., Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital and study co-principal investigator, presented the 12-month outcomes from SUPERB in the Late Breaking Trials session of the 10th VIVA Conference held in Las Vegas, Nevada.
The SUPERB study enrolled 264 patients at 34 centers across the country, treating 266 lesions with a mean length of 8 cm. De novo or restenotic lesions in the superficial femoral and proximal popliteal arteries of 40-140 mm in length were enrolled. Key results included:
- The primary safety endpoint of freedom from death, target lesion revascularization (TLR) or any amputation of the index limb to 30 days post-procedure, was met by 99.6 percent of the patients.
- The study also exceeded the primary efficacy endpoint with a statistically significant improvement over the objective performance goal established by the FDA and VIVA Physicians, Inc. for vessel patency at one year.
- Based on survival analysis, the SUPERA stent achieved freedom from loss of primary patency at one year of 86 percent.
- Freedom from TLR of 90 percent
- Zero reported stent fractures at one year.
"In the SUPERB trial, the SUPERA stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the SFA and proximal popliteal artery," said Dr. Rosenfield. "The unique design of the SUPERA stent and its combination of flexibility and radial strength may account for this stent's ability to restore durable patency."
The SFA and proximal popliteal artery are exposed to significant mechanical stress with bending and rotation of the knee, which represents a harsh environment for any endovascular device. An ideal stent for use in these areas should offer a significant range of motion without interrupting the anatomical function of the arteries.
"SUPERA is first in a new class of stents engineered with an interwoven wire technology that best mimics vascular anatomy. These results challenge the current dogma of other stent and drug-eluting stent technologies to achieve optimal and durable femoropopliteal arterial patency," noted co-primary investigator Lawrence Garcia, M.D., Chief, Interventional Cardiology and Vascular Interventions at Steward St. Elizabeth's Medical Center.
"The SUPERA stent design may offer physicians a new option to treat significant disease states in one of the fastest growing markets, which is driven by diabetes, obesity, sedentary lifestyles, an aging population and improved detection," stated Christopher M. Owens, President and CEO of IDEV. "Therapies must have both clinical evidence and an economic benefit approach; SUPERA has significant unmatched advantages in both of these categories. We are extremely pleased with the results from the SUPERB pivotal IDE Trial, which are consistent with other large data sets that are being presented on SUPERA at the VIVA conference."
Data from the SUPERB trial will be utilized for IDEV's premarket approval (PMA) application with the FDA, which the Company anticipates filing in the fourth quarter of 2012. The SUPERB trial data is consistent with and validates the numerous reported single-center registries and retrospective studies and is an exciting piece of the growing wide-body of clinical evidence that IDEV is delivering on SUPERA.
"SUPERB enrollment and follow up rates were well beyond the stated study goal and ensure that results are credible and that the study was performed to the highest current standards," said Laura Mauri of Harvard Clinical Research Institute (HCRI).
The SUPERB Trial (Comparison of the SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) is an FDA approved IDE trial to evaluate SUPERA in treating patients with obstructive SFA disease.
SUPERB data analysis was performed independently and validated by the Harvard Clinical Research Institute (HCRI).
About the SUPERA Stent
The SUPERA stent 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).
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.
SOURCE IDEV Technologies, Inc.