Devices & Diagnostics

Soft tissue repair company resolves FDA warning letter

More than a year after it received a warning letter from the U.S. Food and Drug Administration, Anulex Technologies, a soft tissue repair company in Minnesota, announced that it has resolved the matter.

 

More than a year after it received a warning letter from the U.S. Food and Drug Administration, Anulex Technologies, a soft tissue repair company in Minnesota, announced that it has resolved the matter.

The FDA had granted Anulex a 510(k) approval for the Xclose soft tissue repair system to be used for general and orthopedic surgery. But after the company did a post-market study to see how Xclose performed in spinal procedures and began to promote its use, the FDA sent the warning letter.

“You failed to submit an IDE application to the FDA and ensure that an FDA-approved IDE was obtained before allowing subjects to participate in the ‘Randomized Study of Anular Repair with the Xclose Tissue Repair System’,” the warning letter said.

On Wednesday, an Anulex spokeswoman said that the medical device company had complied with all FDA requirements and was marketing the product only for general and orthopedic surgery under which the 510(k) was granted.

“We are encouraged that the FDA has taken a positive view of our corrective actions,” said Jeff Peters, Anulex’s CEO, in a news release. “Patient safety has always been, and continues to be, our foremost priority. The post-market study, as well as considerable usage outside the study, has not resulted in the reported occurrence of any patient safety issues or adverse events beyond those anticipated for procedures involving suturing in general and other orthopedic surgeries.”

The company is working with the FDA to broaden the intended use of the Xclose to spinal surgeries, said Amy Rotenberg, a spokeswoman.

Meanwhile, Anulex, which already had a round of layoffs last year, seems to have shed more employees. In an interview  in April after Anulex received the warning letter, Tim Miller, currently the firm’s senior vice president and general manager, said that 45 people worked at the company. The number is now down to 30.

[Photo Credit: David Castillo Dominici]

Shares0
Shares0