1. Medtech Insight
  2. >>Policy & Regulation

Endo Unit Shutdown Could Strand Incontinence Treatment Praised By FDA Panel

Endo International plans to shutter its Astora Women's Health business unit – formerly part of American Medical Systems – this month due to ongoing legal concerns tied to the company’s vaginal mesh products. What’s unclear is what this means for the company’s investigational fecal incontinence treatment, which received unanimous support from an FDA advisory panel just days before the shutdown was announced.

Astora Women's Health's TOPAS treatment for fecal incontinence seemed headed to market after FDA’s Gastroenterology and Urology Devices Panel unanimously recommended approval on Feb. 25. (See Also see "TOPAS Fecal Incontinence Device Gets Unanimous Support For Approval At FDA Panel" - Medtech Insight, 26 February, 2016..) The mesh implant would be the first device of its kind to treat the difficult and socially isolating condition, which some estimates say affects up to 22% of women older than 60 (See Also see "Medtech Solutions For The "Other" Incontinence" - Medtech Insight, 20 October, 2015.).

But during an earnings call held just four days after the panel vote, Astora parent company Endo International PLC...

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

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 
• By Amanda Maxwell

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By Ashley Yeo

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Biden-Era Device Trial Snapshot Pilot Halted Amid DEI Policy Shift

 
• By Elizabeth Orr

The FDA's Device Clinical Trial Snapshot Pilot, aimed at increasing trial transparency and diversity, has been canceled following President Trump’s anti-DEI executive order. Critics warn this may hinder trial transparency, impacting public health and demographic data accessibility.