Medical device giant Edwards Lifesciences (NYSE:EW) touted China State Food & Drug Administration approval for its Carpentier-Edwards Perimount replacement mitral heart valve, part of the Perimount suite of devices that Edwards says are "the world’s most frequently implanted valves for more than 30 years."
Made of bovine pericardial tissue, the Perimount mitral valve has been in clinical use since 1984 and features proprietary ThermaFix anti-calcification processing. The device has been on market in the U.S. since 2000 and also has CE Marking for European distribution.
"Edwards’ family of Perimount pericardial valves have been the world’s most frequently implanted valves for more than 30 years," according to Edwards Lifesciences.
"The Perimount Mitral Heart Valve provides an important therapeutic option for mitral valve replacement, particularly for those patients with lifestyle considerations that may not be compatible with the lifelong blood-thinning medication required with mechanical heart valves," Fuwai Hospital and China National Heart Center president Dr. Shengshou Hu said in prepared remarks. "This valve offers excellent hemodynamics and established long-term durability, providing Chinese surgeons with an important new, yet clinically established, treatment for their patients suffering from mitral valve disease."
Mitral heart valve repair has gotten some attention lately, with Italian medical device maker Sorin Group (BIT:SRN) this week announcing a $5.4 million (€4.2 million) minority investment with option-to-buy in HighLife SAS, developer of transcatheter mitral valve replacement technology.
Earlier this month transcatheter valve maker CardiAQ Valve Technologies raised $33.2 million, successfully closing an equity funding in support of its mitral valve replacement technology.
EW shares were up 0.9% to $84.69 as of about 12:15 p.m. today.