I know A few months ago Corevalve got the CE mark (European) for Valve in Valve Aortic Valve for HIGH RISK or unable to have surgery, patients who need a new Aortic valve because their original tissue valve is failing.
Today I saw that now Edwards Sapien Valves, both Aortic AND MITRAL have also gotten the CE mark, for people whose tissue Aortic or Mitral valves are failing and they are high risk
"VINE, CA, February 05, 2014 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark in Europe for valve-in-valve procedures using the SAPIEN XT transcatheter heart valve, providing a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery. Edwards is the only company to receive a valve-in-valve indication for the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery.
"The European approval of the SAPIEN XT system for valve-in-valve procedures is a milestone achievement. While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.
More than 300,000 valve replacements are performed worldwide each year through open-heart surgery, utilizing either bioprosthetic tissue valves or mechanical valves"......"
Oops just realised i forgot to put the link http://www.edwards.com/newsroom/Pages/NR20140205.aspx
Yes right now it is just for highest risk people, but already i am sure it will be a huge help for many people. In my opinion it is amazing how quickly the field is growing and things are being approved.
Hopefully these will be available in the US soon.
I thought I'd add the link for Corevalve's CE Mark for VinV approval since I didnt see it here http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1823561&highlight
Today I saw that now Edwards Sapien Valves, both Aortic AND MITRAL have also gotten the CE mark, for people whose tissue Aortic or Mitral valves are failing and they are high risk
"VINE, CA, February 05, 2014 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark in Europe for valve-in-valve procedures using the SAPIEN XT transcatheter heart valve, providing a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement, and who are at extreme risk for surgery. Edwards is the only company to receive a valve-in-valve indication for the mitral position, which addresses an unmet need within the clinical community to provide an alternative to a high-risk surgery.
"The European approval of the SAPIEN XT system for valve-in-valve procedures is a milestone achievement. While this is not a large financial opportunity, it represents an important benefit for patients unable to go through a second open-heart surgery to replace their failing bioprosthetic valves," said Larry L. Wood, Edwards' corporate vice president, transcatheter heart valves.
More than 300,000 valve replacements are performed worldwide each year through open-heart surgery, utilizing either bioprosthetic tissue valves or mechanical valves"......"
Oops just realised i forgot to put the link http://www.edwards.com/newsroom/Pages/NR20140205.aspx
Yes right now it is just for highest risk people, but already i am sure it will be a huge help for many people. In my opinion it is amazing how quickly the field is growing and things are being approved.
Hopefully these will be available in the US soon.
I thought I'd add the link for Corevalve's CE Mark for VinV approval since I didnt see it here http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1823561&highlight
Last edited: