Edwards Launches Magna Mitral Heart Valve Following FDA Approval

Full article reprinted from "The Gray Sheet" - September 8, 2008

Find out how Edwards LifeSciences will launch its Perimount Magna Mitral heart valve immediately now that it has received PMA supplement approval.

Full article reprinted from "The Gray Sheet" - September 8, 2008

Edwards Launches Magna Mitral Heart Valve Following FDA Approval

Edwards LifeSciences will launch its Perimount Magna Mitral heart valve immediately now that it has received PMA supplement approval, the firm announced Sept. 3.

The pericardial bovine tissue-based bioprosthetic is the first such product available in the U.S. designed specifically for mitral valve replacement, according to Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy.

Most currently marketed mitral valves are "just aortic valves turned upside down," the exec said in a same-day interview with "The Gray Sheet."

Magna Mitral, however, has an asymmetric shape, low profile and expansive sewing cuff, which provide "ease of implantation in a difficult valve position, low ventricular projection and strong hemodynamic performance," A. Marc Gillinov, a Cleveland Clinic surgeon and Edwards consultant, explained in a release.

The technology builds on Edwards' Perimount Magna Aortic heart valve, which debuted in the U.S. in 2004, and will help Edwards defend against recent competitive entries from St. Jude Medical and Sorin, states Wachovia analyst Larry Biegelsen.

"In particular, [St. Jude's] Biocor has taken share from [Edwards] partly because Biocor is perceived to be easier to implant in the mitral position than" Edwards' Theon mitral valve, Biegelsen says.

The analyst notes that FDA approval of Magna Mitral supports his forecast of 10% growth in Edwards' surgical heart valve sales to $566 million in 2008. The forecast is on the lower end of the company's guidance of $555 million-$580 million.

The long-awaited FDA approval of Magna Mitral, which has been available in Europe since 2005, follows Edwards' submission of responses to an agency request for incremental testing and analysis in the second quarter. The firm will now focus on answering questions from FDA on another supplement for its Magna Ease aortic valve, which is designed for enhanced implantability and expected to launch in 2009 (¹"The Gray Sheet" July 28, 2008, p. 8).

- Brooke McManus

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