FDA sends Edwards more queries about LifeStent SFA application

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has sent Edwards Lifesciences, a provider of technologies to treat advanced cardiovascular disease, additional questions, regarding its submission for premarket approval of LifeStent products for a superficial femoral artery (SFA) indication.

The questions pertain to “preclinical bench testing and the clarification of open items already under review by the FDA,” according to the Irvine, Calif.-based company.

Edwards said it expects to respond promptly to the FDA and continues to anticipate receiving an SFA indication by the end of the year.
Earlier this year, Edwards completed the sale of its LifeStent product line to CR Bard.