FDA News

Majority of FDA advisory committee finds anular closure device unsafe for prevention of disc reherniation

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the FDA had mixed votes for three questions regarding the safety, efficacy and benefits of an anular closure device to prevent reherniation in patients who underwent discectomy.

The three questions the panel were given were related to the premarket approval of the device Barricaid anular closure device (Intrinsic Therapeutics Inc.). The panel voted 5 to 9 that the device is safe, voted 12 to 1 with 1 abstaining that the implant is effective and voted 5 to 8 with 1 abstaining that the benefits of the prosthesis outweigh the risks.

The meeting focused on the results of a prospectively controlled, superiority study of 554 patients who underwent limited discectomy. Of the total patients, 276 were randomized to undergo discectomy with the Barricaid device and 278 were considered control patients and underwent discectomy alone. Investigators followed the patients for 24 months for co-primary endpoints: reherniation and a composite of the device’s safety and efficacy. Barricaid is intended to be used in patients with radiculopathy (with or without pain), a posterior or posterolateral herniation, and a large anular defect. The device is to be implanted after patients undergo limited discectomy for the prevention of reherniation and for the recurrence of pain or dysfunction.

Safety, efficacy

Most of the panel said there was not enough evidence to prove Barricaid was safe for its indicated use. Panel chairman, Rajkumar D. Rao, MD, an orthopedic surgeon from the George Washington Medical Faculty Associates in Washington D.C., noted most of the panel had concerns regarding the endplate lesions observed after the Barricaid was implanted. He said it was unclear as to what the radiographic lesions represented on a histological basis, that the impact of these lesions on bones that may not have normal mineralization was unknown and that it was unknown as to what these lesions were going to do long-term in terms of inflammatory or fibrotic response.

During the vote, temporary voting member Eli M. Baron, MD, a spine and neurosurgeon from the Cedars Sinai Spine Institute, noted the “high rate of breakage of the device, the high rate of migration [and] also the unknown nature of lesions” in the young patient population. He said, “[We] do not know what is going to happen years down the line.”

Baron added, “I do believe in a selected group of patients the benefits do outweigh the risks, providing the patient is counseled that there is a lot unknown and that this may pose a risk in the future. In my opinion, they should be able to get this device.”

Members of the panel felt the sponsor offered strong evidence that indicated the device was effective.

“I think the sponsors showed rigorous data proving over the time period of the study that the Barricaid-implanted arm was superior for multiple endpoints, both radiological and clinical, compared to the control,” temporary voting member Ty K, Subhawong, MD, associate professor of clinical radiology from the University of Miami, said.

Post-approval studies

If the FDA chooses to issue premarket approval for the anular closure device, the FDA advisory committee proposed a long-term follow-up of 5 years to better demonstrate the safety and efficacy of the device compared with the control.

“I think a post-approval study to follow these lesions out would be prudent, but I did not think it was enough to convince me the device was not safe.” Subhawong, said. – by Monica Jaramillo

Reference s :

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM588125.pdf

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM588141.pdf

The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee of the FDA had mixed votes for three questions regarding the safety, efficacy and benefits of an anular closure device to prevent reherniation in patients who underwent discectomy.

The three questions the panel were given were related to the premarket approval of the device Barricaid anular closure device (Intrinsic Therapeutics Inc.). The panel voted 5 to 9 that the device is safe, voted 12 to 1 with 1 abstaining that the implant is effective and voted 5 to 8 with 1 abstaining that the benefits of the prosthesis outweigh the risks.

The meeting focused on the results of a prospectively controlled, superiority study of 554 patients who underwent limited discectomy. Of the total patients, 276 were randomized to undergo discectomy with the Barricaid device and 278 were considered control patients and underwent discectomy alone. Investigators followed the patients for 24 months for co-primary endpoints: reherniation and a composite of the device’s safety and efficacy. Barricaid is intended to be used in patients with radiculopathy (with or without pain), a posterior or posterolateral herniation, and a large anular defect. The device is to be implanted after patients undergo limited discectomy for the prevention of reherniation and for the recurrence of pain or dysfunction.

Safety, efficacy

Most of the panel said there was not enough evidence to prove Barricaid was safe for its indicated use. Panel chairman, Rajkumar D. Rao, MD, an orthopedic surgeon from the George Washington Medical Faculty Associates in Washington D.C., noted most of the panel had concerns regarding the endplate lesions observed after the Barricaid was implanted. He said it was unclear as to what the radiographic lesions represented on a histological basis, that the impact of these lesions on bones that may not have normal mineralization was unknown and that it was unknown as to what these lesions were going to do long-term in terms of inflammatory or fibrotic response.

During the vote, temporary voting member Eli M. Baron, MD, a spine and neurosurgeon from the Cedars Sinai Spine Institute, noted the “high rate of breakage of the device, the high rate of migration [and] also the unknown nature of lesions” in the young patient population. He said, “[We] do not know what is going to happen years down the line.”

Baron added, “I do believe in a selected group of patients the benefits do outweigh the risks, providing the patient is counseled that there is a lot unknown and that this may pose a risk in the future. In my opinion, they should be able to get this device.”

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Members of the panel felt the sponsor offered strong evidence that indicated the device was effective.

“I think the sponsors showed rigorous data proving over the time period of the study that the Barricaid-implanted arm was superior for multiple endpoints, both radiological and clinical, compared to the control,” temporary voting member Ty K, Subhawong, MD, associate professor of clinical radiology from the University of Miami, said.

Post-approval studies

If the FDA chooses to issue premarket approval for the anular closure device, the FDA advisory committee proposed a long-term follow-up of 5 years to better demonstrate the safety and efficacy of the device compared with the control.

“I think a post-approval study to follow these lesions out would be prudent, but I did not think it was enough to convince me the device was not safe.” Subhawong, said. – by Monica Jaramillo

Reference s :

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM588125.pdf

www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM588141.pdf