Edwards Lifesciences' transcatheter aortic valve implantation systems proves effective in the 1st reports from a global registry of TAVI patients, but safety issues raise eyebrows.
MASSDEVICE ON CALL — The 1st reports from a global registry comparing Edwards Lifesciences' (NYSE:EW) Sapien transcatheter aortic valve implantation systems against open surgery came with mixed results.
The Sapien TAVI device 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.