Navigation Links
Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System

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.

(Logo: )

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. (Nasdaq, TASE: ELRN). For more information about Impliant, please visit

SOURCE Impliant, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Eligard(R) six-month formulation successfully completes European approval procedure
2. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
3. Medical Services International Inc. Completes Testing for European Union (EU) Application
4. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
5. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
6. Launch of second European Cancer Research Funding survey
7. European directive will halt use of MRI scans; cancer diagnosis and treatment will suffer
8. Pharsight to Host European Software Conference
9. OmniGuide Begins European Commercialization
10. Paving the way for future pan-European clinical trials
11. US, European cancer educators gather in Alabama for meeting
Post Your Comments:
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... According ... at the recent 2015 American Dental Association meeting in Washington D.C. revolved around the ... protect a patient’s overall health. The talk stressed the link between periodontal disease (more ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... ... November 27, 2015 , ... "When I was traveling, ... from Hillside, N.J. "Many people catch diseases simply from sitting on such dirty ... be protected from germs." , He developed the patent-pending QUDRATECS to eliminate the ...
(Date:11/27/2015)... ... 27, 2015 , ... ProSidebar: Fashion is a set of 30 ... ProSidebar: Fasion, video editors can easily add an informative sidebar to any FCPX production. ... Utilize presets featuring self-animating drop zones, lines, bars, and text with the ease of ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec ... Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for end users ... Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ membership status ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... ) has announced ... High Viscosity Drugs" report to their offering. ... addition of the "Self Administration of High ... --> Research and Markets ( ) ... Administration of High Viscosity Drugs" report to ...
(Date:11/25/2015)... 2015  The total global healthcare industry is expected to ... Latin America has the highest projected growth ... Japan ), is second with growth projected at ... increased healthcare expenditure. In 2013-2014, total government funded healthcare was ... 2008-2009 to 41.2% in 2013-2014. In real terms, out of ...
Breaking Medicine Technology: