PRINCETON, N.J., June 26 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities on its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis. The procedure was performed by the Lead Clinician of the London Spine Clinic, Mr. John C. Sutcliffe, MB ChB, FRCS.
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Impliant had voluntarily suspended all clinical activities in September of last year following one device-related failure. After an extensive investigation conducted by a third-party expert in medical device retrievals and the Impliant Research and Development team, it was determined that device misalignment coupled with excessive shear loading caused the failure. As a result, Impliant has made a few minor design and manufacturing changes to the internal components of the TOPS(TM) device that allow it to better withstand high shear loads and misalignment while not affecting its range of motion.
“I am pleased with the changes Impliant has made to the TOPS(TM) System,” said Mr. Sutcliffe. “I feel the device is now even better suited to stabilize the spinal segment after performing the wide decompression that my severely stenotic patients require. However, it should be noted that all of my patients with the original TOPS(TM) design continue to do extremely well, some of which have reached 12 months post-op.”
Marcus Klarl, Vice President of European Clinical Affairs for Impliant, stated, “We are pleased to resume our TOPS(TM) clinical activities outside the United States and build upon the excellent outcomes generated to date by Mr. Sutcliffe and our other TOPS(TM) investigators.”
The TOPS(TM) single and multi-level family of products have been implanted in over 80 patients in Brazil, South Africa, Belgium, Turkey, Israel, Germany and the United Kingdom. The company also recently received FDA approval to restart its TOPS(TM) IDE clinical study in the United States.
Impliant is applying cutting-edge materials and crossbar biomechanical techniques to develop a new class of spine arthroplasty devices that target over 40% of the 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 L3-4 or L4-5 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 over 500,000 patients worldwide undergoing spinal fusion surgery each year. Impliant obtained CE Mark approval for the TOPS(TM) System on June 1, 2006.
About Impliant, Inc.
Impliant, Inc. is a privately held company engaged in the development of novel spine arthroplasty solutions for some of the most prevalent pathologies of the spine. The company is currently developing the TOPS(TM) System, which has the longest clinical history in the Total Posterior Arthroplasty market segment, dating to January 2005. Impliant is also developing several next- generation and multi-level technologies to further increase its addressable market. Impliant is headquartered in Princeton, NJ with research facilities located in Ramat Poleg, Israel. Shareholders include Elron Electronic Industries Ltd. . For more information about Impliant, please visit http://www.impliant.com.
CONTACT: Todd Potokar, President & CEO, +1-609-779-6800,
tpotokar@impliant.com; or Marcus Klarl, Vice President, European Clinical
Affairs, +491742323112, mklarl@impliant.com, both of Impliant, Inc.
Web site: http://www.impliant.com/
