TAVI global registry delivers 1st results | MassDevice.com On Call

October 3, 2012 by MassDevice staff

Edwards Lifesciences' transcatheter aortic valve implantation system proves effective in the 1st reports from a global registry of valve-in-valve TAVI patients, but safety issues raise eyebrows.

Updated October 3, 2012, at 9:45 p.m. to correct the lead story.

MassDevice On Call

MASSDEVICE ON CALL — The 1st reports from a global registry evaluating Edwards Lifesciences' (NYSE:EW) Sapien transcatheter aortic valve implantation inside a failing valve or mitral ring came with mixed results.*

The Sapien TAVI valve-in-valve procedure proved effective after 1 year, but in-hospital mortality proved a significant issue, affecting 10 of 91 patients, TheHeart.org reported.

"These deaths were mostly related to access-site bleeding and other major life-threatening bleeding events like tamponade," investigator Dr. Danny Dvir told the news site. "I hope that this is related to a learning-curve issue and that when many of the sites gain more experience doing these procedures we will see better early results.

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