Navigation Links
Impliant Restarts Pivotal Clinical Trial for Patented TOPS(TM) Spine System
Date:5/27/2008

PRINCETON, N.J., May 27 /PRNewswire/ -- Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has received FDA approval to restart patient enrollment in a pivotal IDE trial of its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080527/NETU060LOGO )

Impliant voluntarily suspended enrollment in the study 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.

Paul McAfee, M.D., Chief of Spine Surgery, St. Joseph's Medical Center and TOPS(TM) Principal Investigator, stated, "Impliant should be commended for the responsible way they responded to the one device failure encountered in the study. Excessive shear force has contributed to the failure of several posterior motion devices. I believe the shear testing conducted by Impliant will become the new standard for all posterior motion devices going forward. I am impressed by the level of detail in their investigation in diagnosing and fixing the issue. I look forward to resuming the study and building upon the outstanding clinical results generated thus far in the IDE and under protocol outside the United States."

"This is a very gratifying day for Impliant," commented Todd Potokar, President and CEO of Impliant. "The resumption of our TOPS(TM) clinical study represents the culmination of a lot of hard work and support by individuals both inside and outside the organization. We are especially grateful to all of our investigators for their input, dedication and support over the past several months. We are all very excited to get started again."

Impliant has enrolled 74 patients to date in its prospective, randomized IDE study comparing the TOPS(TM) System to a traditional posterior fusion. The company also currently has 75 TOPS(TM) patients enrolled under single and multi-level protocols in Brazil, Belgium, Turkey, and Israel. Page 2 of 2

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. The TOPS(TM) System is 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 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: ELRN, TASE: ELRN). For more information about Impliant, please visit http://www.impliant.com.


'/>"/>
SOURCE Impliant, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
4. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
5. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
6. CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation
7. Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule
8. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
9. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
10. Interim Response and Safety Analyses Support Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-Cell Lymphoma
11. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
(Date:9/19/2017)... 2017 HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, ... three leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has ...
(Date:9/12/2017)... NEW YORK , Sept. 12, 2017   EcoVadis , the ... chains, has published the first annual edition of its Global CSR Risk ... 20,400 companies evaluated by EcoVadis, based on Scorecard Ratings that analyzed nearly ... ... Performance Index ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... , ... October 12, 2017 , ... Planet Fitness, one ... U.S., announced today its plans to open a flagship location in Covington, LA at ... former Rooms To Go store next to Office Depot in the Holiday Square shopping ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a ... health care, have expanded their existing home health joint venture through an agreement, ... been operating a joint venture home health company with Asante, delivering clinically integrated ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa ... contributed a medical article to the newly revamped Cosmetic Town journal ... the hair transplant procedure known as Follicular Unit Extraction (FUE). , ...
Breaking Medicine News(10 mins):