Michael Barbella, Managing Editor05.16.24
Aetna has issued a revised Clinical Policy Bulletin (CPB) deeming Getinge's iCast covered stent system "medically necessary" for treating iliac arterial occlusive disease. The insurance provider previously designated the medical device as experimental and investigational.
The determination was based upon a review in March of currently available clinical information, according to the CPB, including clinical outcome studies in peer-reviewed published medical literature; the technology's regulatory status; evidence-based guidelines of public health and health research agencies; evidence-based guidelines and positions of national health professional organizations; views of physicians practicing in relevant clinical areas; and other relevant factors. The last CPB review of peripheral vascular stents took place in October 2023.
“We are very pleased Aetna determined the iCast covered stent system to be medically necessary for the treatment of iliac arterial occlusive disease,” said Therese Mueller, Vice President of Sales, Acute Care Therapies, at Getinge. “We are more thrilled that Aetna member benefit plans will include this new option for consideration when it comes to treatment of this serious and often painful condition.”
The iCast covered stent system is the first to market balloon expandable, fully encapsulated stent that has served more than 850,000 patients. The product is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the native common and/or external iliac arteries up to 110 mm in length, with a reference vessel diameter of 5 to 10 mm. It is not available outside of the United States.
The iCast covered stent received U.S. Food and Drug Administration premarket approval in March 2023 for iliac arterial occlusive disease treatment. The product became commercially available in the United States last fall.
Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.
The determination was based upon a review in March of currently available clinical information, according to the CPB, including clinical outcome studies in peer-reviewed published medical literature; the technology's regulatory status; evidence-based guidelines of public health and health research agencies; evidence-based guidelines and positions of national health professional organizations; views of physicians practicing in relevant clinical areas; and other relevant factors. The last CPB review of peripheral vascular stents took place in October 2023.
“We are very pleased Aetna determined the iCast covered stent system to be medically necessary for the treatment of iliac arterial occlusive disease,” said Therese Mueller, Vice President of Sales, Acute Care Therapies, at Getinge. “We are more thrilled that Aetna member benefit plans will include this new option for consideration when it comes to treatment of this serious and often painful condition.”
The iCast covered stent system is the first to market balloon expandable, fully encapsulated stent that has served more than 850,000 patients. The product is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the native common and/or external iliac arteries up to 110 mm in length, with a reference vessel diameter of 5 to 10 mm. It is not available outside of the United States.
The iCast covered stent received U.S. Food and Drug Administration premarket approval in March 2023 for iliac arterial occlusive disease treatment. The product became commercially available in the United States last fall.
Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs approximately 12,000 people worldwide and the products are sold in more than 135 countries.