FDA warns Entellus Medical over Xpress sinus dilator pediatric trial

The FDA sent a warning letter to Entellus Medical (NSDQ:ENTL) over its failure to prevent physicians from violating the approved protocol for a pediatric trial of its Xpress sinus dilator. The April 6 letter, published online this week by the federal safety watchdog, stems from an inspection that began exactly a year ago of a Plymouth, Minn., Entellus plant that the FDA conducted to review the company’s procedures in sponsoring the pediatric Xpress study. The inspection found “serious violations” of regulations covering investigational device exemptions and the protection of human subjects, involving use of the Xpress dilator in patients under age 12 in frontal and sphenoid sinuses; the trial’s approved protocol only allowed treatment in the maxillary sinus for patients that young, according to the letter. The agency said it expressly denied an Entellus request to expand the trial protocol during a May 13, 2014, conference call and later told the company that any data from off-protocol use could not be used to back a marketing application for frontal and sphenoid treatment in the under-12 cohort. “Yet, 18 out of 33 pediatric subjects received balloon sinuplasty treatment on the frontal and sphenoid sinuses. One clinical investigator performed 11 planned protocol deviations, a second clinical investigator performed 6 planned protocol deviations, and a third clinical investigator performed 1 planned protocol deviation,” according to the lett...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Wall Street Beat Ear Nose & Throat (ENT) Entellus Medical Inc. Warning Letter Source Type: news