Total Facet Arthroplasty System® (TFAS®)

[Justin]

UPDATE 9/4/09: Links to the Archus website are no longer active based on the company's dissolution. However, the FDA Clinical Trial link for the TFAS® is still active.

The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal. TFAS® offers the surgeon new options for treating spinal stenosis patients, enabling a more comprehensive decompression via complete removal of the facets. TFAS® also offers an alternative to rigid spinal fusion fixation enabling intervertebral motion. The clinical trial is intended to demonstrate restoration of stability and sagittal balance to the spine. TFAS® also eliminates the need for painful bone graft harvest from the patient's hip which may be required with fusion procedures.


Side View (Lateral)
TFAS® Total Facet Arthroplasty System®


Rear View (Posterior)
TFAS®Total Facet Arthroplasty System®

Archus® Orthopedics Website. Click here.

Total Facet Arthroplasty System® (TFAS®)

TFAS® is an articulating joint prostheses intended to restore normal motion and provide stabilization of spinal segments in skeletally mature patients. It can be used as an adjunct to laminectomy, laminotomy, neural decompression and facetectomy, in lieu of fusion, for treatment of instabilities or deformities of the lumbar spine including:

• Degenerative disease of the facets;
• Degenerative disease of the facets with instability;
• Grade 1 degenerative spondylolisthesis with objective evidence of neurologic impairment;
• Central or lateral spinal stenosis.

The Total Facet Arthroplasty System® (TFAS®) is a modular implantable device that is intended to replace the facets and excised elements of the posterior lumbar spine following facetectomy and neural decompressive procedures. Implanted via an open posterior surgical approach, TFAS® is fixed within the pedicles and provides immediate alignment and stabilization of the spinal segment at a single spinal level, L3-L4 or L4-L5, while maintaining anatomical ranges of motion. TFAS® is comprised of implantable grade metal components offered in a range of sizes to address the specific anatomical requirements of each patient. Implant component selection is made based upon pre-operative imaging measurements and intra-operative trialing. Pedicle fixation of TFAS® components is accomplished via the use of polymethylmethacrylate (PMMA) cement. Archus Bone Cement, containing 30% barium sulphate, is the only cement validated for use as a component of the TFAS® system. A specialized set of instruments facilitate implantation of the TFAS® components.

TFAS® CLINICAL OBJECTIVES

1. Resolve painful leg symptoms and improve functional capability of the patient.
2. Eliminate lumbar fusion and reconstruct the motion segment following destabilizing decompression of the neural elements.
3. Obviate bone graft harvest procedure required for spinal fusion thus eliminating associated postoperative morbidity.
4. Afford a better view of the neural elements and potentially reduce the number of dural tears associated with pedicle screw fusion, as total facet arthroplasty requires complete removal of the facets allowing improved intra-operative visualization of the dura and nerve roots.
5. Provide a more complete lateral recess decompression compared to decompressive laminectomy alone which attempts to decompress the lateral recess around the facet joint site.
6. Preserve segmental biomechanics, thus reducing the long term potential of destabilizing spinal levels adjacent to the involved spinal segment attributed to use of rigid fusion fixation.
7. Eliminate the incidence of recurrent stenosis by removal of the facets.
8. Eliminate a source of pain in the presence of spinal stenosis by removal of the facets.

Here's a link to the Biomechanical Testing of TFAS --> Click here.

First human implant:

FIRST HUMAN IMPLANT OF NEW ARCHUS ORTHOPEDICS FACET REPLACEMENT SYSTEM

Redmond, WA, April 23, 2008 – Archus Orthopedics, Inc., announced today that it has successfully 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 utilize 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 United States in an ongoing IDE study approved by the U.S. 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 United States, the company’s entire device family is already cleared for commercialization 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.

About Archus Orthopedics
Founded in July 2001, Archus Orthopedics is a privately held company developing a family of reconstructive implants to treat a variety of spine disorders resulting from degenerative changes in the facet joints. Archus has received venture capital funding from MPM Capital, InterWest Partners, Polaris Venture Partners and Johnson & Johnson Development Corporation, in cooperation with DePuy Spine.

# # #

Press Contact:
Jim Fitzsimmons
Chairman and Chief Executive Officer
Archus Orthopedics, Inc.
(425) 284-3650
jfitzsimmons @ archususa.com

Additional Links:

Total Facet Arthroplasty System® (TFAS®) Clinical Trial <--Clickable Link

• Objective: TFAS® is a non-fusion spinal implant for treatment of moderate to severe spinal stenosis as an alternative to rigid spinal fusion.
  
• Design: Treatment, randomized, open label, active control, parallel assignment, safety/efficacy study.
  
• Enrollment: 450

Ages Eligible for Study: 50 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

• Degenerative spinal stenosis, central or lateral, at spinal levels L3-L4 or L4-L5
• Skeletally mature male or female between the ages of 50 and 85 years of age inclusive
• No greater than Grade I degenerative spondylolisthesis at the index level
• Persistent leg symptoms,including pain, numbness, burning or tingling for a minimum duration of six months
• Operative candidates with no more than three levels of degenerative lumbar spinal stenosis requiring decompression
• Failed to respond to non-operative treatment modalities for a minimum duration of six months

Exclusion Criteria:

• Male or female less than 50 or greater than 85 years old Grade 2 or higher spondylolisthesis or any retrolisthesis at the index level
• More than 3 vertebral levels of degenerative spinal stenosis requiring decompression
• More than 1 vertebral level of degenerative spinal stenosis requiring instrumentation
• Not available for long term follow-up and interval visits
• Prior or concurrently planned lumbar fusion or disc replacement at any level of the lumbar spine
• Two or more previous surgeries to the lumbar spine at the same level to be implanted
• Is being treated with other devices for the same disorder (e.g. pain control devices)
• Active systemic infection or infection at the operating site
• Osteoporosis
• Known sensitivity to device materials
• Has an immunosuppressive disorder
• Has a medical condition that may interfere with clinical evaluations
• Is obese defined by a patient body mass index greater than 40
• Has significant scoliosis (Cobb >25°)
• Is pregnant or planning to become pregnant within the proposed three year investigation

Click here for an animated video on TFAS®.

[Terry Newton]

Will this device work on the sacroiliac joint? I continue to have some pain in the lumbar area and, have had several SI joint injections, since my four level ADR surgery. I hope that I do not have to have another surgery but, it would be comforting to know that I do have some good alternatives.

This looks interesting.

[cavalier]

This maybe GREAT for the lumbar but they need to also consider the Cervical as well which is even smaller yet.

Jill