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News

Archus completes first human implant for facet joint replacement system

Archus Orthopedics : 24 April, 2008  (New Product)
Archus Orthopedics has completed the first human implant of its TFAS-C system, the newest addition to the company's product line for treating spinal stenosis, a condition in which degenerative changes in the facet joints result in compression of spinal nerves producing neurological symptoms in the legs.
Traditionally, patients with moderate to severe spinal stenosis undergo decompressive laminectomy surgery, which is often accompanied by spinal fusion. Archus products replace degenerative facet joints with a prosthetic joint Implant intended to restore stability and normal motion to the spine, eliminating the need for fusion.

The TFAS-C is indicated for the L3-4 and L4-5 spinal levels and complements the company's TFAS-LS system, which entered the clinic in late 2007 and addresses the unique anatomy of the L5-S1, ‘lumbosacral’ spinal level.

Both systems utilise conventional pedicle screw fixation and join the company's first product, the Total Facet Arthroplasty System or ‘TFAS’, which is anchored by means of bone cement and has been successfully implanted in nearly two hundred patients worldwide, with the vast majority treated in the USA in an ongoing IDE study approved by the US Food and Drug Administration.

The milestone case was performed in Europe by Dr Scott Webb from the Florida Spine Institute, assisted by Dr Radu Prejbeanu, Dr Ioan Branea and Dr Dinu Vermesan.

'The TFAS-C is easy to Implant and our first case was very straightforward,' said Dr Webb, a pioneering spine surgeon who performed the first TFAS implantation in 2005, which was one of the earliest facet joint replacement procedures ever completed. 'The full product line that Archus has developed for spinal stenosis allows me to treat almost all comers and gives me multiple device options to address variable patient anatomy and pathology,' he added.

'The TFAS-C completes our spinal stenosis product line and it is gratifying to see all three devices now in clinical use,' said Jim Fitzsimmons, chairman and chief executive officer.

While Archus will conduct clinical trials of the TFAS-C and other new products to gain marketing approval in the USA, the company's entire device family is already cleared for commercialisation in the European Union.

'We expect to complete marketing trials this year and plan to pursue a broad but controlled launch in Europe next year,' said Fitzsimmons.
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