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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 consider Intrinsic's PMA for the Barricaid anular closure device. The meeting will come about one year after the firm completed its PMA submission for the device, including two-year outcomes from the 554 patients

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More from Policy & Regulation

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

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Don’t Sleep On Inspections: Experts Warn FDA Maintains Enforcement Resources

 
• By Brian Bossetta

Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.