Edwards gets some new approvals- Hope for ViV TVAR

[ALLBETTERNOW!]

Still a long way to go but a nice leap for valve in valve TAVR. If they can get the morbidity numbers down or close to OHS then I think it becomes the standard of care. Remember Medtronic's is out there pushing their product too

http://www.edwards.com/ns20151015-2


http://www.kcentv.com/story/30271301...lve-procedures[/URL

1-Year Outcomes from PARTNER II Valve-in-Valve Study Demonstrate High Survival, Low Stroke Rate

IRVINE, Calif., Oct. 15, 2015 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards SAPIEN XT transcatheter heart valve.

"We were very pleased to see 100 percent survival at 30 days with the 100 high-risk patients treated with the SAPIEN XT valve-in-valve procedure in the continued access registry," said Danny Dvir, M.D., interventional cardiologist at the Center for Heart Valve Innovation at St. Paul's Hospital, Vancouver, who presented the data. "This is quite remarkable and supports transcatheter aortic valve-in-valve replacement with the SAPIEN XT valve as a safe therapeutic alternative to reoperation for patients in need of a subsequent tissue valve replacement."

Now us " young" people just need them to get working on valve in a valve in a valve...... Or a 2nd valve that will go 25+

 

[ALLBETTERNOW!]

http://www.ocbj.com/news/2015/oct/15/fda-clears-additional-use-edwards-sapien-xt/

 

[ottagal]

Always encouraging to read new advancements, AllBetterNow! Thanks for sharing.
My surgeon wasn't too encouraging about me ever being a candidate for future valve in valve TVAR mostly because of the small size of my bioprosthetic aortic valve.
It would be interesting to know what they used as a minimum 'cut off' size for this group of patients to be eligible for this procedure.

 

[Paleowoman]

I wonder what were the bioprosthetic valves the patients had who were given the Sapien TAVR ? Also what size as ottagal says. I couldn't get a link to the origianl data which would have detailed pateints' characteristics etc, just the newsy article saying how successful it was.

 

[ALLBETTERNOW!]

I wonder what were the bioprosthetic valves the patients had who were given the Sapien TAVR ? Also what size as ottagal says. I couldn't get a link to the origianl data which would have detailed pateints' characteristics etc, just the newsy article saying how successful it was.

Yeah this was more geared towards their stock price. It will be interesting to see the data, I think size will matter but who knows which is why I said Hope, not victory here. I think the biggest hurdle will be getting permission to use on healthier patients and truly challenge OHS as the gold standard whether as a first or redo or valve in a valve not as a last resort . Safety first I guess!! I have an edwards manga so I am selfishly hoping that they are making the new valves to work with their existing offerings. I think I am 23 or 27 mm size which is, I think on the larger size. I will have to check my card. it is something I should know ! 27 mm it is....