1. Medtech Insight
  2. >>Policy & Regulation

Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel

Company’s latest design fails to convince panel leakage issues have been fixed

 
• By Brian Bossetta

The US agency’s Circulatory System Devices Panel found type III endoleaks are still a problem for abdominal aortic aneurysm patients treated with the newest Endologix stent graft, though for some the benefits still outweigh the risks. The panel advised that all patients, however, should continue getting annual screenings.

Entrance to FDA headquarters in Maryland
• Source: Alamy

After lengthy discussions on 2 November, the US Food and Drug Administration’s Circulatory System Devices Panel concluded that AFX graft stents from Endologix, Inc. to treat abdominal aortic aneurysms (AAA) should be reserved for a select group of patients, and not for routine use.

The Endologix system treats patients with AAAs through endovascular grafting, which is a less invasive technique to repair an aneurysm than open surgery. The graft is designed to prevent blood from flowing back into the aneurysm

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.