APPLIED VASCULAR ENGINEERING BEGINS CLINICALS FOR CORONARY MICRO STENT; STUDY OF UP TO 700 PATIENTS WILL COMPARE DEVICE TO J&J'S PALMAZ-SCHATZ
This article was originally published in The Gray Sheet
Executive Summary
Patient enrollment for an investigational device exemption study of Applied Vascular Engineering, Inc.'s coronary Micro Stent began the week of Nov. 6. On Nov. 3, AVE received an IDE for the prospective, randomized study, which will compare the Micro Stent to Johnson & Johnson's Palmaz-Schatz device. Patient enrollment is anticipated to continue for six to 12 months, and a premarket approval application for the device could be submitted in 18-24 months, AVE predicts.