Getinge recieves FDA premarket approval for the iCast™ covered stent system in the US

Rhea-AI Summary

Getinge has received premarket approval from the U.S. FDA for its iCast™ covered stent system, designed to treat patients with iliac arterial occlusive disease, a form of peripheral arterial disease (PAD) affecting 8 million individuals in the U.S.

The global market for covered stents is projected to grow at an annual rate of 5%. Getinge plans to increase production capacity to meet rising demand. The iCast stent, also known as the Advanta V12 outside the U.S., boasts over 20 years of clinical use and is the most clinically evaluated covered stent worldwide, supported by over 550 published articles.

Positive

• FDA premarket approval enhances product portfolio and market access.
• Growing global market for covered stents at a 5% annual rate.
• Established clinical history with over 20 years of use and 550 publications.

Negative

• None.

GOTHENBURG, Sweden, March 24, 2023 /PRNewswire/ -- Getinge's iCast^™ covered stent system has received premarket approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), a serious condition that only in the US affects 8 million persons,¹ in which atherosclerosis narrows and blocks peripheral arteries. As the world population ages and rates of diabetes and obesity rise, it is estimated that more people will be affected with iliac artery disease.

"We are pleased that the iCast™ stent system is approved in the United States for use in iliac arteries to benefit an even greater number of patients", says Elin Frostehav, President Acute Care Therapies at Getinge. "The global market for covered stents is growing at an annual rate of 5%. Getinge will continue to ramp up capacity throughout the year in order to meet the demand."

The iCast covered stent system, which is sold outside the US under the brand name Advanta V12 covered stent, has been used by clinicians for 20 years and is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with clinical data published in more than 550 articles.

Media contact:

Anna Appelqvist, Corporate Communications
Phone: +46 (0)10 335 5906
Email: anna.appelqvist@getinge.com

About Getinge

Getinge is a global provider of innovative solutions for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Based on our first-hand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the everyday life for people, today and tomorrow.

¹ Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(Suppl S):S5–S67

The following files are available for download:

https://mb.cision.com/Main/942/3740488/1940861.pdf	Getinge recieves FDA premarket approval for the iCastâ„¢ covered stent system in the US
https://news.cision.com/getinge/i/elin-1200x600,c3159934	Elin 1200x600
https://news.cision.com/getinge/i/icast-stent,c3159948	iCast stent

 

View original content:https://www.prnewswire.com/news-releases/getinge-recieves-fda-premarket-approval-for-the-icast-covered-stent-system-in-the-us-301781051.html

SOURCE Getinge

FAQ

What is the significance of the FDA approval for Getinge's iCast stent system?

The FDA approval permits the iCast stent system to be marketed in the U.S., potentially increasing Getinge's market share and revenue in the medical device space.

How many people in the U.S. are affected by iliac arterial occlusive disease?

Approximately 8 million individuals in the U.S. are affected by iliac arterial occlusive disease, a type of peripheral arterial disease.

What is the projected growth rate for the global covered stent market?

The global market for covered stents is projected to grow at an annual rate of 5%.

How long has the iCast stent system been in use?

The iCast stent system has been used clinically for over 20 years.

What is the brand name of the iCast covered stent system outside the U.S.?

Outside the U.S., the iCast covered stent system is marketed as the Advanta V12.