In Brief: Medtronic Freestyle
This article was originally published in The Gray Sheet
Executive Summary
Medtronic Freestyle: Firm's stentless porcine aortic heart valve gains FDA approval, the firm announces late on Nov. 26. The device is the second stentless tissue valve to be approved by the agency -- St. Jude's Toronto SPV valve approval was announced Nov. 25. FDA's Circulatory System Devices Panel recommended approval of the Freestyle Sept. 15 ("The Gray Sheet" Sept. 22, p. 11). Medtronic highlights Freestyle's "full-root" configuration and anti-calcium treatment. The valve's Physiologic Fixation tissue curing process maintains "the natural shape and leaflet structure of the valve," the company claims...