Beware of Off-Label Use of Wingspan Stent

Off-label medical device use is a tricky subject and one that has been at the center of many heated debates. It is strictly against the law for manufacturers to promote their products for off-label use, however, physicians have the discretion to use a device in an off-label manner if such use might be beneficial to the patient. Sometimes, however, FDA does try to intervene if the off-label use of a particular device raises a concern about patient safety. Case in point, Stryker's Wingspan Stent System. Approved in 2005 under a Humanitarian Device Exemption, the Wingspan has provoked advocacy groups for years, yet the device has remained on the market. Back in 2012, the advocacy group Public Citizen petitioned FDA to withdraw approval for the stent system that is designed to prevent recurrent strokes in patients who have already had one stroke. The group pointed to a study that found the device actually increased the risk of subsequent strokes and death.  The petition was denied later that year. FDA did, however, narrow the indication for Wingspan use to a select group of patients and conditions, as outlined in the box below. Stryker's Wingspan Stent System is FDA approved only for patients who are between the ages of 22 and 80 who meet all of the following criteria: Two or more strokes despite aggressive medical management; Most recent stroke occurred more than seven days prior to planned treatment with Wingspan; 70%...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news