Full article reprinted from "The Gray Sheet" - July 6, 2009
FDA's Circulatory System Devices Panel will review a humanitarian device exemption application for Medtronic's Melody transcatheter pulmonary valve and Ensemble delivery system July 22, according to a July 2 Federal Register notice. Find out more...
Full article reprinted from "The Gray Sheet" - July 6, 2009
FDA's Circulatory System Devices Panel will review a humanitarian device exemption application for Medtronic's Melody transcatheter pulmonary valve and Ensemble delivery system July 22, according to a July 2 Federal Register notice.
Melody is intended for patients with regurgitant prosthetic right ventricular outflow tract (RVOT) conduits, or patients with stenotic prosthetic RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting. FDA humanitarian device exemptions are reserved for products intended to treat a condition that affects fewer than 4,000 U.S. patients a year.
The Melody system offers a nonsurgical way to restore effective valve function and prolong the life of prosthetic conduits, reducing the need for open heart surgery, according to Medtronic.
Results of a 58-patient feasibility trial released at the American Heart Association annual meeting last November showed Melody reduced right ventricular volume by 18% in subjects with dysfunctional RVOT conduits.
Medtronic hopes to launch Melody in the U.S. in 2010. The device already has a CE mark and is available in Europe and Canada, the firm notes.
Earlier this year, Medtronic entered the high-growth, transcatheter aortic heart valve market through the $700 million purchase of transfemoral aortic valve maker CoreValve and $325 million acquisition of transapical aortic valve developer Ventor Technologies. Some analysts have projected transcatheter aortic valves could become a billion-dollar-plus worldwide market in five years.
Separately, on July 23, the FDA panel will discuss "general questions about adhesion barriers for cardiovascular use," according to the Federal Register notice.
Some of the questions will focus on "understanding the target population (pediatric and/or adult) that would benefit from these devices and the development of appropriate endpoints for a clinical trial," the notice states.
- Brooke McManus
To start your 30-day, risk-free trial of "The Gray Sheet", contact Elsevier Business Intelligence's Customer Care team toll free at 800-332-2181 or by email at custcare@elsevier.com.
