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 o
'/>"/>

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

Page: 1 2 3

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:1/15/2014)... PALM BEACH GARDENS, Fla. , Jan. 15, 2014  In an ... C. difficile and TB in ambulances and other transport vehicles, an ... being used by rescue personnel for the first time. ... coming in contact with these deadly pathogens, West Palm ...
(Date:1/15/2014)... The Cadence Fitness & Health Center has been certified ... Association, a non-profit organization assisting medically integrated health and ... Fitness & Health Center is the only certified fitness ... Chicagoland area. "The certification means the Cadence ...
(Date:1/15/2014)... 15, 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... offer by its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ... stock of Solta Medical, Inc. (NASDAQ: SLTM ...
Breaking Medicine Technology:Superbugs No Longer Ride In Rescue Vehicles 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3
... Trial... -- MONT-SAINT-GUIBERT, Belgium, November 17, 2010 ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... s = ,; var first_result; // Results are keyed by longUrl, so we need to grab the first one. ...
... 2010 In response to an expressed need by ... facilitate the sharing and exchanging of data among PMP ... will be developing an interconnected communications hub for state ... nine months, will be made accessible to the states ...
Cached Medicine Technology:Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 2Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 3Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 4Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 5Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 6Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 7Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 8Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 9Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 10Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 11Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients 12NABP Developing System to Link Prescription Monitoring Programs Across States to Facilitate Data Exchange 2
(Date:4/23/2014)... health benefits of probiotics, antioxidants and other nutritional compounds, ... chemical industry is getting in on the action. But ... so the industry is responding with clinical research to ... in Chemical & Engineering News (C&EN), the ... Melody M. Bomgardner, a senior editor at C&EN, writes ...
(Date:4/23/2014)... concerned about an increase in adolescents, marijuana use following ... of relief. According to a new study at Rhode ... from states with and without medical marijuana laws, legalizing ... adolescents. The study is published online in advance of ... , "Any time a state considers legalizing medical ...
(Date:4/23/2014)... the bottom of Alzheimer,s disease has been a ... controversies. In the latest crook in the research ... the interaction between proteins associated with the disease. ... ACS Chemical Neuroscience , could have important implications ... Krzysztof Nieznanski and colleagues explain that for years, ...
(Date:4/22/2014)... Health clinics that can provide primary care for ... both hospitals and insurance companies while improving patient ... hospital admissions suggests that health clinics that avoid ... save money by lowering hospital admission rates and ... of economics, Penn State Altoona. , The ...
(Date:4/22/2014)... The International Communication Association will hold its 64th ... theme of the 2014 conference will explore what ... digital society. , Featuring over 2,300 academic papers ... scholars representing over 40 countries, the ICA conference ... the world. This year,s conference features sessions that ...
Breaking Medicine News(10 mins):Health News:RI Hospital physician: Legalizing medical marijuana doesn't increase use among adolescents 2Health News:Clinics not bogged down by red tape can ease health cost burdens 2Health News:International Communication Association to hold Annual Conference in Seattle, Washington 2
... content talking to an imaginary friend rather than a real one ... such a pal can have a positive effect on children. ... in London also insists that imaginary friends are not a sign ... his or her age group, but a sign that your child ...
... drugs may give a man's performance in bed a boost, ... or their relationships . ,A survey of ... have poorer esteem, a weaker sense of masculinity and lower ... dysfunction (ED), including half who had tried drug treatment, and ...
... hope revived for women who feel less than that, after ... claim that stem cells found in the ubiquitous tummy fat ... this is so, it would be killing two birds with ... ,Christened Celution, the procedure involves injecting a 'supercharged' fat ...
... Dr. Endress and his colleagues found that the sizes ... buzz-pollinating bees . The male floral structures, anthers, release ... ,Unlike moths and butterflies that are often brilliantly ... flowers and the fruits they produce have brilliant colors ...
... increases a person's risk of colon cancer by 23 percent ... by a team of researchers from the University of Michigan ... Institute of Oncology in Spain, the CHS National Israeli Cancer ... including Stephen Gruber and Gad Rennert. ,As part ...
... treatments using their knowledge about an obesity drug, orlistat (Xenical ... the laboratory . ,The drug binds and interacts ... protein's function and causes cell death. ,The study ... and W. Todd Lowther at Wake Forest University School of ...
Cached Medicine News:Health News:Stem Cells In Belly Fat To Enhance Or Reconstruct Breasts 2Health News:Size and Position of Floral Anther Plays a Vital Role in Pollination 2Health News:Size and Position of Floral Anther Plays a Vital Role in Pollination 3
... Merit has a complete offering of ... Performa brands, these catheters are designed with ... shaft strength and better push-ability, and large ... in 4, 5, 6 and 7 French ...
Used to negotiate tortuous vessels....
Used for vascular and non-vascular applications. Tapered fixed core construction provides gradual transition to a flexible,tip. Supplied sterile in peel-open packages. Intended for one-time use....
Used to negotiate tortuous vessels....
Medicine Products: