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Tuesday, September 27, 2022

MEDICAL DEVICE NEWS MAGAZINE

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Camber Spine Launches SPIRA-P and SPIRA-T Implants for National Distribution

In August of 2021, the U.S. Food and Drug Administration Gave 510(k) Clearance for Both Products

Camber Spine a leading innovator in spine and medical technologies, has initiated the full national launch of its SPIRA-P Posterior Lumbar Spacer and SPIRA-T Oblique Posterior Lumbar Spacer devices.

News of the national launch comes on the heels of Camber’s announcement last month that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for both products, which are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1.

Part of the SPIRA® product platform, the SPIRA-P Posterior Lumbar Spacer can be utilized to accommodate PLIF or TLIF procedures and features a patented open architecture design for optimal endplate load distribution. Plus, its uniquely designed surface allows for cell adhesion and bone cell proliferation while its interconnected porosity design mimics bone.

The SPIRA-T Oblique Posterior Lumbar Spacer features the same qualities, but is designed specifically to accommodate traditional or “insert and rotate” TLIF procedures. Uniquely, its shape is angled for a 25° oblique insertion technique to optimize lordosis.

As with all products within Camber’s SPIRA technology platform, SPIRA-P and SPIRA-T include strategically placed and optimal sized openings for graft packing. The SPIRA products are designed to decrease the risk of subsidence with optimized endplate distribution and provide good visibility for fusion. The devices’ bone-like surface design promotes “mechanical fusion” bone ingrowth for short term stability and optimized biomimetic scaffolding designed to encourage osteogenesis.

SPIRA-P and SPIRA-T will be among the products displayed at Camber’s booth (#2027) at the North American Spine Society (NASS) 36th Annual Meeting in Boston next week.

“We are very excited to deliver more innovation-based solutions and options to the surgical community with our national launch of SPIRA-P and SPIRA-T, the first SPIRA implants available for the TLIF market,” said Camber Co-Founder and CEO, Daniel Pontecorvo. “Providing structural stability following discectomy, the SPIRA Posterior Lumbar Spacers have different shapes and designs to accommodate a broader array of posterior and transforaminal approaches and techniques.”

Pontecorvo added that Camber will also be launching an articulating, arched TLIF SPIRA cage product in early 2022.

SPIRA implants are 3D printed. This specialized manufacturing technology allows Camber to create unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth.

All of Camber Spine’s products are developed and manufactured in the United States.

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