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Device Designed To Improve Spine-Surgery Outcomes Gets FDA Panel Date

 
• By David Filmore

US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.

Intrinsic Therapeutics Inc. says a 554-patient randomized, superiority trial supports use of its Barricaid device following a standard spine procedure to prevent re-herniation and recurrence of pain or dysfunction. In December, a US FDA advisory panel will weigh the evidence.

The agency issued a notice Oct. 16 announcing that its Orthopaedic and Rehabilitation Devices Panel will meet Dec. 12 to...

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