IDEV's Pivotal SUPERB Trial Demonstrates SUPERA® Stent Significantly Exceeds VIVA Criteria For One-Year Patency In Femoropopliteal Artery Disease
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). About SUPERBThe 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).
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