Getinge has earned U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its iCast covered stent system, which is now approved as a bridging stent for the treatment of patients with aneurysmal disease.

The new indication lets physicians preserve blood flow between a branch vessel and an endovascular graft that’s approved for use with the iCast covered stent. iCast first received FDA approval to treat patients with iliac arterial occlusive disease in 2023.

”We are proud to bring this important new product indication to the U.S. market,” said Chad Carlton, VP Endovascular Solutions at Getinge. “It represents another step forward in improving outcomes for patients with complex vascular disease.”

In March 2024, Getinge and Cook Medical began a distribution deal under which Cook assumed sales, marketing, and distribution responsibilities for the iCast covered stent in the U.S. The device, now with the expanded bridging stent application, will continue to be distributed by Cook Medical.

“Since the agreement with Cook Medical began, we’ve been able to reach more patients with iliac occlusive disease,” Carlton added. “This expanded scope extends treatment to more patients, allowing for the treatment of aneurysmal disease in conjunction with an approved endograft. We look forward to continuing our collaboration to help even more patients benefit from our endovascular solutions.”