Meditech Spine lumbar fusion devices receive US FDA clearance

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Meditech has announced the launch of its Talos lumbar interbody fusion device comprised of PEEK hydroxyapatite (PEEK-Optima HA Enhanced, Invibio Biomaterial Solutions)—the newest generation of the product—following US Food and Drug Administration (FDA) approval.

Meditech’s Talos device is an intervertebral body device intended for use in skeletally mature patients with degenerative disc cisease of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. The device is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

“We took a ‘wait and see’ approach with our introduction of PEEK-Optima HA Enhanced in our cervical implants in 2015,” says Eric Flickinger, co-founder of Meditech Spine. “With nearly two years of data, we saw enough clinical evidence and heard enough positive surgeon feedback to convince us to move our lumbar portfolio to this new technology. Bone ongrowth, and better and faster fusion outcomes are what surgeons look for in their patient follow up. This is exactly what we have seen, similar to the preclinical ovine study, with our cervical IBFs with PEEK-Optima HA Enhanced material.”

The Talos system is a family of interbody devices that are designed to allow surgeons to choose their preferred method of approach for each patient, whether it be a posterior, transforaminal, anterior or other lumbar interbody fusion procedure.

Meditech plans to introduce the six different lumbar interbody fusion footprints of Talos-P (HA), Talos-P WB (HA), Talos-T (HA), Talos-TL (HA), Talos-A (HA) and Talos-L (HA) later this year. With this release, Meditech has added more footprints, as well as hyperlordotic and asymmetric sizes. The devices are designed with large graft windows to allow packing of autograft or allograft and come with disc preparation instruments to help facilitate and streamline the procedure. Talos implants will continue to be supplied in sterile packaging.

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