Anulex Technologies, maker of soft tissue repair devices, has been forced to lay off employees after the Food and Drug Administration issued a warning letter regarding trials of its Xclose soft tissue repair system, according to a MedCity News report.
According to the FDA's warning letter, the agency had granted 510(k) approval of the Xclose system for the intended use of soft tissue approximation for procedures such as general and orthopedic surgery. However, after the FDA's clearance, the company conducted trials for the device's use in repairing the annulus fibrosus, which required an IDE application to the FDA.
The FDA considers annulus fibrosus repair to be a new intended use, apart from soft tissue approximation. According to the warning letter, Anulex also failed to comply with federal regulations prohibiting the promotion of a device for unapproved uses and failed to obtain investigator agreements.
Anulex President and General Manager Tim Miller defended the company's actions, stating the company had consulted with 34 centers, none of which recommended submitting an IDE application. Mr. Miller also said the company obtained informed consent from all patients involved in the post-market study on annulus repair. Despite his defense, the company has terminated all marketing of the Xclose system related to spine procedures, which eventually forced the company layoffs, according to the news report.
Read the news report about the FDA warning letter and layoffs at Anulex.
Read other coverage about FDA warning letters:
- Smith & Nephew Receive FDA Warning Letter Regarding Quality Control Issues
- FDA Sends Warning Letter to Anulex for Inappropriate Testing of Spinal Product
- Smith & Nephew Responds to FDA Letter of Warning
According to the FDA's warning letter, the agency had granted 510(k) approval of the Xclose system for the intended use of soft tissue approximation for procedures such as general and orthopedic surgery. However, after the FDA's clearance, the company conducted trials for the device's use in repairing the annulus fibrosus, which required an IDE application to the FDA.
The FDA considers annulus fibrosus repair to be a new intended use, apart from soft tissue approximation. According to the warning letter, Anulex also failed to comply with federal regulations prohibiting the promotion of a device for unapproved uses and failed to obtain investigator agreements.
Anulex President and General Manager Tim Miller defended the company's actions, stating the company had consulted with 34 centers, none of which recommended submitting an IDE application. Mr. Miller also said the company obtained informed consent from all patients involved in the post-market study on annulus repair. Despite his defense, the company has terminated all marketing of the Xclose system related to spine procedures, which eventually forced the company layoffs, according to the news report.
Read the news report about the FDA warning letter and layoffs at Anulex.
Read other coverage about FDA warning letters:
- Smith & Nephew Receive FDA Warning Letter Regarding Quality Control Issues
- FDA Sends Warning Letter to Anulex for Inappropriate Testing of Spinal Product
- Smith & Nephew Responds to FDA Letter of Warning