Why an FDA Panel Shot Down Intrinsic & #039;s Spinal Implant

Although FDA doesn't have to follow the recommendation of its advisory committees, a negative panel vote is never a good sign for a company hoping to bring a new device to the market. Intrinsic Therapeutic learned the hard way Tuesday that it's usually best if clinical trials follow the protocol that was initially communicated to the agency. Changes to the device trial, along with other concerns FDA staff raised, caused an advisory panel to vote against recommending approval for Intrinsic's Barricaid prosthesis, according to a MedPage Today report. The device is designed for partial annulus replacement in patients with herniated discs. FDA staff raised concerns in a briefing document prior to the advisory panel meeting. In the document, the agency noted that Intrinsic planned to enroll a study population that includes people with an increased risk of disc reherniation who would potentially benefit from a permanent implant to prevent reherniation compared to discectomy alone. Yet, when staff reviewed the submitted data it appeared that the enrolled study population didn't exactly match that description, based on published literature regarding the incidence of "at risk" disc herniations. For example, the Barricaid study had a much lower number of fragment-fissure type anular defects which are associated with a low rate of recurrent lumbar disc herniation in the enrollment population. Additionally, the agency found that most of the study subjects appeared to receive anulotomi...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news