Navigation Links
Pioneer(R) Surgical Technology's NuBac(R) Nucleus Replacement Device Wins FDA Approval for IDE Pivotal Study
Date:10/30/2008

First Company to Reach Pivotal Study for Spine Nucleus Replacement

MARQUETTE, Mich., Oct. 30 /PRNewswire/ -- Pioneer Surgical Technology, Inc. announced today, the U.S. Food and Drug Administration (FDA) granted approval to proceed to IDE Pivotal Study of the NuBac(R) Nucleus Replacement Device for the spine.

Pioneer's CEO and Chairman of the Board, Matthew N. Songer, MD, MBA says, "This is a huge milestone and accomplishment for Pioneer to be the first to receive FDA approval to start the IDE pivotal study for nucleus replacement. Many other companies, pursuing nucleus replacement technology, have spent more time and money than Pioneer and have not achieved this significant goal." Songer added, "This record speed to obtain FDA approval to proceed demonstrates our dedication to focused innovation and ability to bring new products to market faster than many of our competitors."

The NuBac implant system is the only Nucleus Replacement device that utilizes an articulating inner ball and socket design that seeks to achieve load sharing and uniform stress distribution under various physiological loading conditions while minimizing extrusion risk. The NuBac implant is made of PEEK-OPTIMA(R) material which offers well established biocompatibility, biodurability, excellent wear resistance, and radiolucency.

Pioneer's Vice President for Advanced Spine, Chip Bao, PhD states, "There are some inherent challenges in the development of nucleus replacement devices. Pioneer's unique design features of the NuBac implant have led to a series of successful pre-clinical studies and encouraging results from both the initial U.S. IDE feasibility study and post-market surveillance outside the U.S. under the CE mark."

Spinal Disc Arthroplasty surgery includes Total Disc Replacement (TDR) and Nucleus Replacement procedures. Both techniques seek to relieve discogenic back pain caused by degenerative disc disease, restore stability and flexibility to
'/>"/>

SOURCE Pioneer Surgical Technology, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine news :

1. Pioneer(R) Surgical Technology Announces the Market Release of its Cross-Fuse(TM) Lateral Vertebral Body Replacement (VBR) System
2. Pioneer(R) Surgical Technology Introduces the BacJac(TM) Interspinous Decompression System to the European Spine Market
3. Pioneer(R) Surgical Technology, Inc. Continues to Prove Science Behind PEEK-on-PEEK(TM) Technology for Motion Preservation Devices
4. Many Breast Cancer Patients Are Not Receiving Most Advanced Breast Conserving Surgical Techniques, New Study Finds
5. STAAR Surgical Reports 33% Third Quarter Revenue Growth
6. New National Patient and Surgeon Surveys Show Post-Surgical Care Critical to Optimal Weight Loss After Bariatric Surgery
7. An analysis of the surgical and perioperative complications in right hepatectomies
8. Surgical technique halts cell loss, Parkinsons researchers find
9. Dr. Lisa Zdinak Announces, CO2TouchTM Brazilian Carboxytherapy - New Technology for Non-Surgical Treatment of Stretch Marks, Cellulite and Dark Undereye Circles
10. Older Adults Reluctant to Question Surgical Treatment
11. Study shows that surgical weight loss does not eliminate obstructive sleep apnea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/21/2014)... HealthDay Reporter FRIDAY, Dec. 19, 2014 (HealthDay ... traditional cigarettes, new research finds. Even though they ... of ex-smokers said they have fewer cravings and are less ... smoke, researchers reported. "The pattern was really ... than for tobacco use," said lead researcher Jonathan Foulds, a ...
(Date:12/21/2014)... 21, 2014 The number of Mirena ... consolidated litigation underway in New Jersey, Bernstein Liebhard LLP ... 1,375 claims involving the birth control IUD have now ... were filed by women who allege spontaneous migration of ... uterine perforations and other complications they were inadequately warned ...
(Date:12/21/2014)... Francisco, California (PRWEB) December 21, 2014 ... his search for Vintage 1967 Jm Morrison and the Doors ... concert posters. This would also be the only time ... The concert was on Nov. 25, 1967. According to ... Washington D.C. They did play the Alexandria Roller Rink ...
(Date:12/21/2014)... Over the past 39 years, NES Health ... emergency departments across the nation, from quality of medical ... into an innovative suite of tools, systems, and programs ... the patient experience. , NES Health, a leading ... services for hospitals, announced the development and launch of ...
(Date:12/21/2014)... Viejo, California (PRWEB) December 21, 2014 ... Studios have announced a new intro plugin for Final ... to animate pictures, videos, logos, and more with absolute ... “We’ve given our users the tools needed to easily ... ProMotion allows Final Cut Pro X users to animate ...
Breaking Medicine News(10 mins):Health News:E-Cigarettes Less Addictive Than Regular Cigarettes, Study Finds 2Health News:E-Cigarettes Less Addictive Than Regular Cigarettes, Study Finds 3Health News:Mirena Lawsuits Approach 1,400 in Bergen County Litigation, Bernstein Liebhard LLP Reports 2Health News:Mirena Lawsuits Approach 1,400 in Bergen County Litigation, Bernstein Liebhard LLP Reports 3Health News:NES Health Launches Stipend Program for Emergency Physicians in Training to Financially Assist Emergency Department Doctors While They Learn 2Health News:Announcing a new plugin for Final Cut Pro X ProMotion from Pixel Film Studios. 2
... on Alzheimer,s disease, its causes, symptoms, treatment and possible cures. ... Alzheimer,s Project", which includes four HBO documentaries and a nationwide ... ... Lauderdale, FL (PRWEB) May 12, 2009 -- WebmasterRadio.FM, the premier ...
... of the,Avon Foundation for Women, today joined area ... leaders for a day of events to celebrate ... Center at the San,Francisco General Hospital and Trauma ... progress possible in breast cancer research and,care. The ...
... Cancer Research and Care in San Francisco Award-Winning ... May 11 Reese ... Avon Foundation for Women, today joined area breast cancer ... a day of events to celebrate the 5th anniversary ...
... May 11 The American Academy of Actuarie ... and health care stakeholder groups to tackle health spending growth ... health care system."Increasing health care spending threatens the sustainability of ... divert both public and private funds from other priorities," said ...
... Cardium Therapeutics (NYSE Amex: CXM ) ... quarter ended March 31, 2009, and on recent ... made significant progress in the first quarter 2009 ... on the InnerCool Therapies and Tissue Repair Company ...
... , Montreal, May 11, 2009 When it ... equal hand. The latest study by Dr. Maya Saleh, of ... McGill University, shows that women have a more powerful immune ... females could have a beneficial effect on the innate inflammatory ...
Cached Medicine News:Health News:Inside Story of HBO's Alzheimer's Project with Series Producer John Hoffman and Dr. Laurie Ryan on WebmasterRadio.FM's "Rainmaker" 2Health News:Inside Story of HBO's Alzheimer's Project with Series Producer John Hoffman and Dr. Laurie Ryan on WebmasterRadio.FM's "Rainmaker" 3Health News:MultiVu Video Feed: REESE WITHERSPOON JOINS AVON FOUNDATION FOR WOMEN AND SAN FRANCISCO GENERAL HOSPITAL TO CELEBRATE 5TH ANNIVERSARY OF AVON COMPREHENSIVE BREAST CENTER 2Health News:Video: Reese Witherspoon Joins Avon Foundation for Women and San Francisco General Hospital to Celebrate 5th Anniversary of Avon Comprehensive Breast Center 2Health News:Video: Reese Witherspoon Joins Avon Foundation for Women and San Francisco General Hospital to Celebrate 5th Anniversary of Avon Comprehensive Breast Center 3Health News:Video: Reese Witherspoon Joins Avon Foundation for Women and San Francisco General Hospital to Celebrate 5th Anniversary of Avon Comprehensive Breast Center 4Health News:Actuaries: Addressing Health Spending Growth is Path to Sustainable Health Care System 2Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 2Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 3Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 4Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 5Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 6Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 7Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 8Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 9Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 10Health News:Cardium Reports on First Quarter 2009 Financial Results and Recent Developments 11Health News:Equality of the sexes? Not always when it comes to biology 2
(Date:12/17/2014)... 17, 2014 With advancements in neurological ... market is seeing new growth, according to Kalorama ... account for the majority of market volume, newer ... images, which are creating opportunities for more sophisticated applications. ... growing at a rate of 4%, with world ...
(Date:12/17/2014)... , The new ... of information concerning the biopharmaceutical Group,s national and international clinical ... to the recently launched institutional website that is receiving accolades ... by a new chapter in the fascinating story of Drug ... and panoramic hub on the world of clinical research, ranging ...
(Date:12/17/2014)... N.J. , Dec. 17, 2014  IGI Laboratories, ... today the closing of its offering of $125 million ... 2019 (the "Notes").  The Notes were offered and sold ... under the Securities Act of 1933, as amended (the ... a fixed rate of 3.75% per year, payable semiannually ...
Breaking Medicine Technology:Kalorama: 3T Advancements Bringing New Growth to the MRI Market 2Kalorama: 3T Advancements Bringing New Growth to the MRI Market 3Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 2Dompé Offers a New "Window" on the World of Scientific Research, with the http://www.dompetrials.com Website, Dedicated to Clinical Trials 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 2IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 3IGI Laboratories Announces Closing of $125 Million of 3.75% Convertible Senior Notes Due 2019 4
... Nov. 12 A new treatment for autism appears ... S. Starr, MD, FAACAP, BCIA-EEG. , In ... characteristically common "u" EEG pattern reflecting impaired brain function, ... interaction, communication, speech and bonding. , ...
... MINNEAPOLIS/ST. PAUL, Nov. 12 /PRNewswire / -- ... for Integrative Oncology,s (SIO) Sixth International Conference in ... and safety of complementary and alternative medicine (CAM) ... Director, Hematology/Oncology at Children,s Hospitals and Clinics of ...
Cached Medicine Technology:New Treatment for Autism 'Holds Promise' 2New Treatment for Autism 'Holds Promise' 3New Research Shows Promise in Using Traditional Research Methods to Assess Efficacy of Complementary Therapies 2
The safePICO is a prebarcoded arterial sampler that helps you ensure patient and caregiver safety. SafePICO is part of 1st automatic, the worlds first automatic blood gas analysis system....
Measure SpO2 and tcpCO2 with a single sensor....
Two separate sensors provide continuous measurement of tcpO2/tcpCO2 and SpO2....
... components that comprise the SmartPill GI ... comprise the SmartPill GI Monitoring System: ... Receiver software and SmartPill MotiliGI software. ... indispensable parts of the SmartPill GI ...
Medicine Products: