Medtronic valve approval
This article was originally published in The Gray Sheet
Executive Summary
Firm begins shipping the Hancock M.O. II porcine tissue valve the week of Dec. 20 following FDA approval of a supplement to the Hancock Modified Orifice premarket approval application. The new device features "a scalloped, flexible suture ring" that can be shaped by hand "to approximate the contours of a small, irregular or calcified annulus," the firm says. The valve is priced at approximately $4,400