The FDA hit Anulex Technologies Inc. with a warning letter over “serious violations” at a facility in Minnetonka, Minn.
The watchdog agency says the company failed to obtain regulatory approval for a clinical study before enrolling human subjects.
Anulex’s study on its Xclose tissue repair system included the implantation of the device in 750 subjects, according the the warning letter.
The company was required to submit an investigational device exemption application to the FDA because of the risks posed to the study’s participants. The FDA considers Anulex’s Xclose a "significant risk device" because it’s implanted and "presents a potential for serious risk to the health, safety, or welfare" of a patient.
The Xclose product uses braided polyester bands to make an X-shaped stitch over openings in the soft tissue around the spine.
Anulex’s product offering also includes the FDA-cleared Inclose surgical mesh system for supporting soft tissue in treatments such as hernia repair, according to the company’s website.