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.
A total of 155 patients with peripheral artery disease were treated at 17 investigational sites in the United States, Europe, and New Zealand in the Bolster trial for the treatment of atherosclerotic lesions in common and external iliac arteries.
Restenosis is assessed by duplex ultrasonography (DUS), where the target lesion(s) is determined to have a peak systolic velocity ratio (PSVR) greater than 2.4 with poststenotic turbulence, as determined by an independent DUS core lab. In this study, a PSVR of more than 2.4 suggests greater than 50% restenosis.
At the time of the analysis, 155 subjects passed their nine-month visit and were evaluated for the primary and secondary endpoints. Restenosis through nine months following the procedure was among the factors measured in the study’s primary endpoint composite. Patients will be followed through 36 months.
Bard won pre-market approval from the FDA for the LifeStream covered iliac stent for treating peripheral artery disease in June 2017. The PMA covers the treatment of atherosclerotic lesions in common and external iliac arteries with diameters of 4.5mm to 12.0mm and lesion lengths of up to 100mm, Murray Hill, N.J.-based Bard said.
The LifeStream device has been on the U.S. market since that approval and in Europe since 2014.
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