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Classified in: Health, Science and technology
Subject: FDA

Next Generation Lumbar Fusion Devices by Meditech Spine Aims to Improve Surgical Outcomes, Receives FDA Clearance

ATLANTA, June 19, 2017 /PRNewswire/ -- Spine surgery offers a new lease on life for patients experiencing back pain and discomfort. With an estimated 450,000+ lumbar fusions performed each year in the United States, surgeons are familiar with Meditech Spine's Talos® Lumbar Peek devices as essential components in the procedures they perform. And now Meditech offers surgeons the next generation of their already successful devices, the Talos® Lumbar (HA) Peek IBF that has received US Federal Drug Administration (FDA) 510(k) clearance to be marketed.

To impact the lives of patients, surgeons, and those in need all around the world.

Surgeons treating patients with Degenerative Disc Disease (DDD), defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, consider a lumbar decompression and fusion to help relieve symptoms in the spine. Meditech's Talos® Lumbar (HA) Peek IBF device is an intervertebral body device intended for use in skeletally mature patients with DDD of the lumbar spine with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2-S1. These devices are intended to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

The Talos® Peek Lumbar IBF devices have been adopted and utilized throughout the US market since 2010. With this most recent FDA approval, Meditech will now market the Talos® lumbar interbodies with Invibio Biomaterial Solutions, PEEK-OPTIMA® HA Enhanced material.

PEEK-OPTIMA® HA Enhanced is a novel material for these interbody cages, contributing to the fusion process as it is strong, versatile and based on PEEK-OPTIMA® polymer compounded with hydroxyapatite (HA), a well-known osteoconductive material for enhancing bone apposition. This component is not a secondary surface coating or added texture but is completely integrated throughout the polymer and, consequently, throughout the implant and all surfaces. Since Meditech's Talos®-C (HA) Cervical IBF clearance in 2015, Meditech and surgeons have observed similar results that mimic a preclinical ovine study that demonstrated better ongrowth and improved fusion when compared to Peek alone1 .

"We took a 'wait and see' approach with our introduction of HA Peek 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® HA Peek Lumbar System is a family of interbody devices that allows surgeons to choose their preferred method of approach for each patient whether it be a PLIF, TLIF, TPLIF, ALIF or LLIF. Meditech will introduce the six different lumbar IBF 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 to meet surgeons' needs for their patients. 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. All the Talos® IBF implants will continue to be supplied in sterile packaging to aid in traceability and help reduce possible infection.


Walsh WR, Pelletier MH, Bertollo N, Christou C, Tan C. Does PEEK/HA Enhance Bone Formation Compared With PEEK in a Sheep Cervical Fusion Model? Clin Orthop Relat Res. 2016; DOI 10.1007/s11999-016-4994-x


Meditech Spine, LLC, is a spinal implant company that partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech's pursuit of novel and innovative technologies drives its design and development team. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best available technologies. For more information visit www.meditechspine.com.

Caption & Copyright:
Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved. PEEK-OPTIMA® is a registered trademark of Invibio, Ltd. All rights reserved.

Meditech Spine, LLC
1447 Peachtree Street, Suite 440
Atlanta, GA 30309
Phone: 678-974-5287
Email: support@meditechspine.com


SOURCE Meditech Spine, LLC

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