Getinge recently announced that it has received US Food and Drug Administration (FDA) premarket approval (PMA) for the iCast covered stent system. The device is now available as a bridging stent for the treatment of patients with aneurysmal disease.
Getinge states that this new indication enables physicians to preserve blood flow between a branch vessel and an endovascular graft that is approved for use with the iCast covered stent.
”We are proud to bring this important new product indication to the US market,” said Chad Carlton, vice president Endovascular Solutions at Getinge. “It represents another step forward in improving outcomes for patients with complex vascular disease.”
Ongoing collaboration with Cook Medical
In March 2024, Getinge and Cook Medical entered into a distribution agreement under which Cook assumed sales, marketing, and distribution responsibilities for the iCast covered stent system in the USA. The product, now with its expanded bridging stent indication, 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.”
