Impliant Conducts The First Two Implantations Of Its New TOPS VersaLink Spinal System

Main Category: Bones / Orthopaedics
Also Included In: Neurology / Neuroscience;  Medical Devices / Diagnostics
Article Date: 10 Oct 2009 - 1:00 PDT

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Impliant, Inc., a developer of novel motion-sparing alternatives to traditional spinal fusion surgery, announced that it conducted the first two implantations of its TOPS VersaLink System, the newest addition to its product portfolio.

The system is comprised of the company's flagship TOPS(TM) Total Posterior Arthroplasty device, a motion-sparing posterior implant designed to treat moderate to severe lumbar stenosis with or without spondylolisthesis and facet arthrosis, attached to the company's recently-developed VersaLink Fixation System(TM). By combining the two devices, the TOPS VersaLink System allows the surgeon to treat different stages of spinal degeneration at two or more adjacent vertebral segments. Surgical treatment of patients with advanced multi-level spinal degeneration has traditionally consisted of a fusion device that spans all of the diseased segments following decompression of the patient's pain generators. However, the TOPS(TM) portion of the TOPS VersaLink System restores near-normal motion to its segment and may thereby reduce the potential for adjacent segment degeneration that may accompany conventional fusion-only constructs.

The first case was conducted by Mr. John Sutcliffe at the London Clinic Medical Center in London, England. "I was impressed with the simplicity of the system. Implantation was very easy and straightforward," commented Mr. Sutcliffe. "VersaLink is a logical next step in the evolution of the TOPS(TM) System. It gives me the ability to address a larger array of patients in my practice, and I fully expect to achieve similar clinical results that I have enjoyed thus far with Impliant's original TOPS(TM) device."

Mr. Sutcliffe's comments were echoed by Dr. Robert Hes and Dr. Bart Conix, who together performed the second surgery at the Middelheim Hospital in Antwerp, Belgium. "It is a very elegant system. We are excited by the flexibility that VersaLink gives us in treating our patients," remarked Dr. Hes.

"We are pleased to add the VersaLink System to our product line," said Todd Potokar, President and CEO of Impliant. "It allows us to expand beyond treating single-level spinal stenosis and opens the door for us to help patients with a much wider range of spinal pathology. The versatility of the system will even allow us to compete in the fusion market as a unique stand-alone fusion device."

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. The TOPS(TM) System is currently not approved for sale in the United States.

About the VersaLink Fixation System

The VersaLink Fixation System(TM) is a bilateral titanium lumbar fusion system that is designed to be used in conjunction with a titanium crossbar as a stand-alone fusion device. It is also designed to connect above or below the company's flagship TOPS(TM) device as a hybrid construct. The VersaLink Fixation System(TM) is intended to treat patients with a broad range of spinal pathologies including degenerative disc disease (DDD), disc herniation, lumbar spinal stenosis, and spondylolisthesis. The VersaLink Fixation System(TM) has received CE Mark approval but is currently 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 some of the most prevalent pathologies of the spine. The company's flagship product is 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 the VersaLink Fixation System, the TOPS-SP System, and several other 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. (Nasdaq & TASE: ELRN).

Source: Impliant, Inc