Medtronic Renal Plus
This article was originally published in The Gray Sheet
Executive Summary
Renal stent system commences 25-center non-randomized registry study following investigational device exemption clearance from FDA March 26. Medtronic says the study will enroll up to 225 patients for the peripheral application. The six-crown, 17 mm stent to be used in the study was commercially launched outside the U.S. in August 1998 mounted on a different delivery system. The IDE follows the February 510(k) clearance of the Bridge stent for biliary indications