- Autoimmune Disorders in Women Possibly Triggered by Seafood
- FDA Approves Noninvasive Colorrectal Cancer Test
- FDA Approves Limited Use of Drug for Ebola
- FDA Approves Edwards Lifesciences Corporation’s Sapien XT
- Lymphoseek Injections Approved by FDA for Prolonged Extended Use
- Orexigen Therapeutics’ Contrave Awaits FDA’s Nod
- FDA Expressed Concern on E-Cigarette Smoking after Increase in Complaint Rate
- E-Cigarette Marketing to Be Regulated by FDA Appealed As They Pose Serious Threat to the Youth
- FDA Goes Tough on Honey with Added Sweeteners
- Is Your Honey Adulterated?
FDA Approves Edwards Lifesciences Corporation’s Sapien XT
- Updated: June 18, 2014
SAPIEN XT, the second generation implantable heart valve developed by Edwards Lifesciences Corporation received approval from FDA. SAPIEN XT is used for treating patients with severe aortic stenosis who are considered high risk for surgery or are unable to undergo surgery. Following the approval the company’s shares have seen a rise in trading.
“Although the approval took a couple of months longer than we expected, the broad label and broad range of sizes are a positive development for Edwards and will help keep Edwards competitive with Medtronic’s CoreValve, in our view,” states Wells Fargo analyst Larry Biegelsen, in a note to investors.
Sapien XT is an improved version of Sapien that was introduced in 2010. It will be available in three sizes; 23 mm, 26 mm and 29mm. The 29 mm implant will be suitable for patients who need a larger valve. This size will make Sapien XT more competitive with Medtronic’s CoreValve which is available in 31 mm size.
Management at Edwards is hopeful that Sapien XT will help physicians treat a greater number of people who need valve replacement but are inoperable or high risk for the standard procedure. Standard valve replacement surgery involves sawing the breastbone in half, stopping the heart, cutting out the old valve and sewing a new one in its place.
Sapien XT will be available to patients at cardiovascular centers across the nation. The valves will be implanted through a 16-French expandable sheath (eSheath) and the Ascendra+ transapical and transaortic delivery systems. Nearly 70,000 patients have been treated globally with Sapien and Sapien XT valves till date. Sapien XT was approved in Europe and Japan in 2010 and 2013 respectively.