Impliant Receives CE Mark Approval For The TOPS-on-Fusion(TM) System, The First Integrated Motion Preservation System For Spinal Fusion Patients

Main Category: Medical Devices / Diagnostics
Also Included In: Bones / Orthopaedics;  Clinical Trials / Drug Trials
Article Date: 15 Mar 2007 - 0:00 PDT

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Impliant, Inc. (http://www.impliant.com), a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that its wholly owned subsidiary, Impliant Ltd., has received CE Mark approval for its patented TOPS-on-Fusion(TM) System. This is the world's first total posterior motion preservation device that integrates lumbar fusion with total posterior arthroplasty at two adjacent levels to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.

"In clinical trials in South Africa, Belgium and Turkey, the TOPS-on-Fusion(TM) System has demonstrated effectiveness in alleviating pain stemming from degeneration of the posterior elements," said Marcus Klarl, European Vice President for Clinical Affairs. "Surgical intervention is delayed for as long as possible in favor of conservative treatment. By the time many patients reach the operating room, their spine disease has advanced to two levels. The TOPS-on-Fusion(TM) System is the optimal solution for many of these cases."

The procedures have been performed by Dr. Louis Nel from South Africa, Dr. Azmi Hamzaoglu from Turkey, and Drs. Bart Conix and Robert Hes from Belgium.

Drs. Hes and Conix stated, "The TOPS-on-Fusion(TM) device provides an integrated fusion and motion preservation solution for patients with two-level disease. It is common to have patients with advanced disc and posterior disease at one-level and isolated posterior problems at the adjacent level. The TOPS-on-Fusion(TM) System stabilizes both segments while allowing motion at the level adjacent to fusion."

The TOPS-on-Fusion(TM) System is the second in a family of products at Impliant that provide surgeons with a broad range of alternatives to traditional spinal fusion. The device is indicated for L3-L5 and L4-S1 patients where the inferior segment is fused and the superior level is treated with total posterior arthroplasty.

Impliant is applying cutting-edge materials and biomechanical engineering techniques to develop a new class of spine arthroplasty devices that target more than 400,000 patients worldwide who undergo fusion surgery and could benefit from a total posterior arthroplasty solution.

About the TOPS(TM) System

Impliant's TOPS(TM) System, a mobile posterior device, is designed to stabilize but not fuse the affected vertebral level to alleviate pain stemming from spinal stenosis with or without degenerative facet arthrosis and spondylolisthesis. Following a laminectomy and medial facetectomy, the device is affixed to the spine via four pedicle screws using a standard posterior surgical approach. Impliant believes that the TOPS(TM) System could benefit patients worldwide undergoing spinal fusion surgery each year. The TOPS(TM) System is in clinical trials and not approved for sale in the United States.

About Impliant, Inc.

Impliant, Inc. is a privately held company engaged in the development of novel spine arthroplasty solutions for motion preservation. The company is currently developing the TOPS(TM) System, which is designed to alleviate pain resulting from degenerative facet arthrosis, spondylolisthesis and spinal stenosis by stabilizing but not fusing the affected vertebral level. Impliant is headquartered in Princeton, NJ with research facilities located in Ramat Poleg, Israel. For more information about Impliant, please visit http://www.impliant.com.

Impliant Ltd.
http://www.impliant.com