Endo Health Solutions (NSDQ:ENDP) saw shares drop 20% today after announcing plans to close its Astora Women’s Health biz in March due to concerns over future product liability related to mesh implants, despite posting a solid earnings beat for Q4 and the full year 2015. The company, along with other medical device makers, have been hit with […]
Astora Women's Health
FDA backs Endo’s Topas mesh to treat fecal incontinence
The FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee this week voted unanimously to back approval of Endo Health Solutions (NSDQ:ENDP) subsidiary Astora Women’s Health’s Topas mesh designed to treat fecal incontinence. The synthetic mesh does not require a transvaginal approach, according to a Medscape report, but is implanted using 4 small […]
Astora lands FDA panel date for Topas incontinence device
The FDA today scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device. The company and federal watchdog are slated to meet in late February to consider the company’s sling mesh device. The Topas is designed to be implanted around the puborectalis muscle for treating women […]