Annular repair. Fixing the rent in the annulus that can often occur because of minimally invasive spine surgery. Fixing the tear will lower re-herniation rates—at least that was the experience that Anulex Technologies, Inc. documented with its thousands of patients treated.
Fixing the annulus is hard to do. The process is not intuitive. Anulex invented a solution. That solution, named Xclose, was employed thousands of times to close the annulus following discectomy surgery before the company went out of business in 2014.
What happened?
The FDA happened—but in an unexpected way.
And…that’s not the end of the story.
Annular Repair
OTW talked with two veterans of the Anulex experience—John E. Sherman, M.D., a spine surgeon with Twin Cities Orthopedics and a former consultant for Anulex and Scott L. Blumenthal, M.D., an orthopedic surgeon with the Texas Back Institute and a former consultant for Anulex.
“Annular repair,” Sherman said, “is necessary because microdiscectomy frequently fails. The rate varies but around 15% of the time you are going to have a symptomatic disc reherniation.”
Is there any other orthopedic procedure with a 15% reoperation rate? Total hips? Total knees?
Of course not. As Sherman told OTW: “If you had total hips or total knees that 15% of the time you had to take them back and revise them, people wouldn’t be happy with that.”
The most common reason, said Sherman, for microdiscectomy failure is a persistent defect in the annulus. But fixing the defect is hard to do. Because of the spinal anatomy, annulus is hard to suture. So, there was a clear need for a device which would simply and safely close the annulus and, thereby, cut that 15% risk of re-surgery for herniation down to practically zero.
Anulex’s System
Minnesota-based Anulex Technologies, Inc. was founded in 2001 and came out of an incubator that was formed by Dale Spencer who was the CEO of SciMed. Spencer had helped found more than a dozen medical device companies. Spencer was on the corporate board of Anulex for its whole existence.
Sherman said, “He took engineers from SciMed and said you are going to be the team that runs Anulex. The original engineer who ran Anulex was Matt Burns.”
Sherman was first introduced to the company by Burns. He asked Sherman to do their initial cadaver lab for the Xclose System, and although there were a few kinks in that first initial concept, after more research and development they zeroed in on what they believed to be a safe and effective way to fix a tear in the annulus.
