IDE trial to evaluate SUPERA in treating patients with obstructive SFA disease : IDEV

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Clinical Studies

Stent Sizing Guide

SUPERB Study Guide

IDEV is currently enrolling the SUPERB (Comparison of the
SUPERA PERipheral System to a Performance Goal Derived from Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery) IDE trial to evaluate SUPERA in treating patients with obstructive superficial femoral artery (SFA) disease. SUPERB is a multicenter, prospective, non-randomized, single-arm study enrolling 258 patients at up to 40 sites. The primary efficacy endpoint is patency greater than 66% at 12 months, defined as freedom from restenosis (measured by duplex ultrasound) and TVR.

The principal investigators leading this study are nationally respected clinicians, Kenneth Rosenfield, M.D. of Massachusetts General Hospital and Lawrence A. Garcia, M.D. of Caritas St. Elizabeth’s Medical Center.

For more information visit the SUPERB Study website, www.superbstudy.com, or click on the button below for the SUPERB Study Guide.

SUPERA® is a different
class of stent.