Minnetonka, MN-based Anulex Techonologies has initiated a round of layoffs following a February warning letter from the FDA.
In the warning letter, the FDA says it found "objectionable conditions" during an Aug. 23-Sept. 22, 2010 inspection of the company's facility. It further states the company failed to submit an IDE application to the FDA and ensure it was approved before allowing subjects to participate in a study of the Xclose soft tissue repair system--which is used during general and orthopedic surgery--for annulus fibrosus repair. The annulus fibrosus is a covering that shields the soft material located at the center of an intervertebral disc, MedCity News notes.
The FDA also cites the company for promoting Xclose for annulus fibrosus repair before the agency had approved the device for commercial distribution, according to the warning letter. It singled out press releases dated Nov. 10, 2009, and Feb. 18, 2010 that stated, "Xclose was cleared in September 2006 for use in soft tissue approximation for procedures such as general and orthopedic surgery. Xclose provides a simple, convenient method for treating the compromised soft tissue of the annulus fibrosus."
Anulex President and General Manager Tim Miller maintained in an interview that the company had consulted with institutional review boards at 34 centers, and no one told the company to get an IDE from the FDA. He also thought the agency had mistakenly exaggerated the risk of using Xclose in spine procedures, as MedCity News notes.
In the warning letter, the FDA states there are inherent risks in spinal surgery--including neurological that do not exist with other orthopedic procedures. "In addition, because the standard of care for disc herniation does not involve an implanted device, subjects in this trial are exposed to additional risks that are associated with device use (e.g., device migration, fracture, removal)," according to the letter.
The company has halted Xclose markeing related to spine procedures, thus leading to jobs and revenue loss. Currently there are 46 employees at the firm, MedCity News reports.