Is the Annulus a Soft Tissue? (Not a Trick Question, Honestly)
Together Sherman and Blumenthal described what happened beginning in 2006, which started off well.
That was the year that Anulex received 510(k) clearance from the FDA to market the Xclose Tissue Repair System as a Class II device since it was like existing Anulex anchor band suturing systems.
The language of the clearance, however, turned out to have an unexpected trap.
The FDA cleared Xclose for “use in soft tissue approximation for procedures such as general and orthopedic surgery”.
Soft tissue. Like an annulus, right? Not bone, for example.
So, Anulex began to market Xclose to spine surgeons to use on the annulus soft tissue to fix tears resulting from discectomy procedures.
Remembers Blumenthal, “Anulex approached a number of sites around the U.S. with this technology with the labeling of soft tissue repair. I thought the technique was very amenable, very easy to take care of a problem that is otherwise technically almost impossible to take care of.”
In addition, Anulex began a prospective, randomized study of annular repair with Xclose in 2007, and posted the study on clinicaltrials.gov—as is required for any study which would like to be published in a peer review journal.
The study investigators enrolled 750 patients. They randomized patients to annular repair and to no repair following a microdiscectomy. All patients were expected to complete their two-year follow-up in October 2011.
In February 2010, Anulex began marketing the Xclose Tissue Repair System.
The FDA Comes Calling
On learning about the study and the commercial release of the device the FDA’s Minneapolis District Office inspected Anulex’s facilities in Minnetonka, Minnesota, in August and September 2010.
That inspection led to a February 2011 warning letter stating that Anulex had mislabeled the Xclose device and needed an FDA approved Investigational Device Exemption (IDE) to test the device on patients.
According to the FDA, annulus repair is not soft tissue repair.
John Sherman, who is a calm Midwestern surgeon, simply said that the FDA’s conclusion was nonsensical.
But the FDA’s charge was serious because it effectively accused the company of putting patients at risk by enrolling them in an unauthorized clinical trial.
Anulex had no choice but to shut down the study.
