C.R. Bard (NYSE:BCR) has notified buyers of its LifeStream covered iliac stent of a higher-than-anticipated restenosis rate among patients.
The field notice issued by Bard, parent company BD and Irish catheter-maker ClearStream Technologies said the restenosis rate of 0.04% exceeds the acceptable failure rate of 0.01%. An unspecified number of restenosis complaints was reported following implantation of the LifeStream stent following normal clinical use and also from the follow-up to the Bolster clinical trial. No patient injuries were reported and the notice is not a product recall, the company said.