Good news on Cath Aortic and Mitral valves

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Lynlw

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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
 
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Thanks, Lyn. That these are currently approved only for high-risk patients is what I expected. If, over time, they prove to be competent for lower-risk patients, then they may be approved by the time some of us need re-op's. At the present, that is all we should hope for. Well, that and contnued interest in testing for lower-risk patients.
 
This looks promising. Thanks for sharing this, Lyn. Let's keep fingers crossed that one day is may be used in our lower risk population.
 
Not sure if this is same thing, but when I was first being evaluated for replacement of my Pulmonary valve at Cleveland Clinic, they mentioned that the heart Drs are going BACK to recommending Bioprosthetic valves for most patients because of the new availability of Melody Valves that are place trans-catheter and can be used for replacing a failing bio valve without need for OHS.

We ended up not being able to plan on this for me however, because my Femoral Vein pathway is not complete and doesn't go directly to my heart. Thus FV caths can't be performed on me. Femoral Artery ones can be, and was at CC, but not the veinous ones. Since it was my PULMONARY valve needing replacement, that made future use of a Melody Valve problematic unless delivery methods changed. Since very few valves are put into the Pulmonary position, I didn't feel comfortable with hoping technology would help at some unknown point down the road and went with the mechanical option.

But, wanted to pass info on since it might help others making the decision between bio and mechanical. There are issues with the Melody Valve, look up stint failure rate. But I didn't explore them fully because of IFV issue already making possible future use of Melody Valve a moot point.


Linda
 

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