Are 34 Institutional Review Boards Wrong?
Thirty-four Institutional Review Boards (IRBs) reviewed the study, the company and the device and approved using Xclose on patients for this study. Furthermore, said Anulex, medical device regulatory experts, health professionals and surgeons all looked at the Xclose and no one said that an IDE was needed.
On top of that, there had been no unusual patient safety issues or adverse events.
As the company told OTW at the time: “Anulex is steadfast in its commitment to conducting its business in full compliance with all regulatory and statutory requirements. While we respect the FDA’s perspective in this matter, we are disappointed to have received the FDA’s letter because we firmly believe our post-market activities related to Xclose have complied with FDA law.”
Sherman, who was also a member of Anulex’s board of directors, remembered, “At the board level we seriously considered suing the FDA because of the capricious decision that the annulus was not soft tissue, that it was something completely different from other predicate devices that we had.”
The board did not ultimately sue the FDA.
Anulex complied with everything the regulators asked.
All marketing for Xclose was changed to clearly be for general and orthopedic surgery only. Management shut down the study. They also met with the FDA several times in the hopes of receiving approval for the device to be used during discectomies to repair the annulus.
For Sherman, the most disturbing part of these multiple meetings with the FDA was hearing the FDA reviewer make a scientifically inaccurate comment that the closing the annulus could cause paralysis in patients if somehow the Xclose device entered the spinal canal.
To understand how improbable that concern was, Dr. Sherman pointed out that the device was only 1mm by 3mm and said, “You can put in 30 of them in and if they came out, the patient would still not be paralyzed.”
Arguing Spinal Anatomy With the Reviewer
Sherman still remembers arguing spinal anatomy with the reviewer.
The reviewer didn’t change her opinion. All the way through the process there was this recurrent theme of catastrophic neurological deficit if the device displaces, even though there was no scientific basis for it.
Blumenthal added that there were thousands of patients who had an Xclose implanted, those done in the study setting and those performed outside of the study, and as far as they know no one had become paralyzed because of the device.
Unfortunately, when the meetings with the FDA ended up going nowhere and their financing dried up, the company shut down in 2014.
