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.
“C. R. Bard is proud to build upon its vast history and experience in angioplasty balloons, stents and covered stents to offer physicians this new option,” chairman & CEO Timothy Ring said in prepared remarks. “The LifeStream covered stent expands the continuum of care available for physicians who trust and rely on Bard products.”
“Intervention in the iliac arteries is a complex and delicate process, and accurate implant placement is especially important given that these arteries control the blood flow for a patient’s entire leg,” added Dr. John Laird of Sacramento’s University of California – Davis Medical Center, principal investigator for the Bolster study backing Bard’s PMA bid. “The LifeStream covered stent enabled physicians to achieve accurate device placement and a durable treatment effect in patients with PAD treated for iliac artery lesions.”
Bard said the 255-patient Bolster study showed a target lesion revascularization rate of 3.9% and a major adverse event rate of 4.7% at 9 months. The trial beat its primary endpoint, a composite safety and effectiveness measure that set an objective performance goal of 19.5%, showing 11.6% on a post-hoc basis and 16.2% on a pre-specified basis.
Bard said the LifeStream device is on the U.S. market and has been available in Europe since 2014.