Navigation Links
FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Date:10/5/2009

FDA to request premarket clinical data for new versions of these devices

SILVER SPRINGS, Md., Oct. 5 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today ordered manufacturers of certain types of pedicle screw systems, called dynamic stabilization systems, to conduct postmarket surveillance studies to collect clinical data on a number of potential safety issues, including fusion rates and frequency of additional surgeries.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO )

Dynamic stabilization systems are used in spinal surgery and some are intended to provide stabilizing support to the spinal column during bone fusion. Currently, there is not enough clinical data to determine whether these dynamic stabilization systems provide enough spinal stability to allow for complete spinal fusion, as the system components may loosen, bend, or break over time. If fusion does not occur, a patient's condition could worsen and possibly require additional surgical procedures.

The FDA is requiring postmarket studies to address these potential risks for systems already on the market. In addition, the FDA is requesting manufacturers with new dynamic stabilization systems or components to submit clinical information for agency review prior to marketing.

The FDA is not recommending any changes regarding the use of dynamic stabilization systems until it collects and reviews clinical data to better understand how these devices are being used. Patients who have or are considering the implantation of a dynamic stabilization system should consult with their health care practitioner.

Dynamic stabilization systems have different design features that allow bending or rotation while still facilitating fusion. Components used to achieve this flexibility include polymer cords, moveable screw heads, and springs
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Quest Diagnostics Introduces ClariSure(TM) Test for Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders in Children
2. S*BIO to Develop New JAK-2 Inhibitor for Treatment of Myeloproliferative Disorders and Hematological Malignancies
3. Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
4. Mayo Clinic Physicians Report Findings from Research on Sleep Disorders
5. Bristol-Myers Squibb, New Jersey Childrens Hospital Launch Center for Immune System Disorders & Infectious Diseases Including HIV/AIDS
6. Study Finds Fever may Lead to Improved Behavior in Children with Autism Spectrum Disorders
7. Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders
8. MJFF and Merck Serono (EMD Serono in North America) Join Forces on $2-Million Initiative to Drive Treatments for PD-Related Cognitive Dysfunction and Mood Disorders
9. Rigel Announces Initiation of Phase 1 Clinical Trial of R348 for Rheumatoid Arthritis, Psoriasis and Other Immune Disorders
10. Intra-Cellular Therapies Presents Data on Its Schizophrenia and Cognition in Schizophrenia Programs at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
11. Cytopia Nominates JAK2 Clinical Candidate for Myeloproliferative Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... , Jan. 23, 2015  Mallinckrodt plc (NYSE: ... Directors has approved a share repurchase program. The open-ended ... million of Mallinckrodt plc ordinary shares. ... remain top priorities as we continue to pursue a ...
(Date:1/22/2015)...  ViewRay™, a privately held medical device company, announced today ... with ITOCHU Corporation (Tokyo Stock Exchange TYO: 8001) to ... of cancer in Japan . ViewRay,s ... and only MRI-guided radiation therapy system that images and ...
(Date:1/22/2015)... - Pivotal Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a ... cardiovascular disease and overall health is pleased to provide you ... its outlook for 2015 from the CEO, Mr. Eugene ... would like to take this opportunity to share with you ...
Breaking Medicine Technology:Mallinckrodt plc Announces Share Repurchase Program 2Mallinckrodt plc Announces Share Repurchase Program 3Mallinckrodt plc Announces Share Repurchase Program 4ITOCHU Named the Exclusive Distributor for ViewRay's MRI-Guided Radiation Therapy System in Japan 2Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7
... Science Liaisons (MSLs) have become a key link between the ... that drive marketplace success. And the role of MSLs - ... the coming years as the device industry turns to them ... Given the expanding role of MSLs, it,s critical for organizations ...
... Watson Pharmaceuticals, Inc. (NYSE: WPI ... authorized generic version of PROMETRIUM® (progesterone, USP) Capsules ... with Abbott Laboratories. Watson began shipping the product ... the prevention of endometrial hyperplasia in non hysterectomized ...
Cached Medicine Technology:New Study Examines the Evolving Role of Medical Science Liaisons in the Medical Device Sector 2Watson Launches Generic PROMETRIUM(R) 2
(Date:1/22/2015)... Gabe’s Chemo Duck Program is pleased to announce the release of ... kids with cancer. The Chemo Duck App, available on iTunes for ... games to help children of all ages living with cancer adjust ... kids entertained, educated and at ease while waiting for clinic visits ...
(Date:1/22/2015)... is a seasoned and trusted leader who consistently delivers trendy ... have it lead the wedding dress industry into the future. ... for the global market. , “The CEO of VogueQueen is ... on continuing the goal of operational excellence and giving back ...
(Date:1/22/2015)... January 23, 2015 Angelweddingdress is a famous ... invites its customers to follow it on Facebook, Twitter, and ... Valentine’s Day gift. Angelweddingdress draws a lottery every week. , ... to Feb. 28, 2015. Click Angelweddingdress homepage for ...
(Date:1/22/2015)... AngelWeddingDress, the premier women’s dress supplier, ... dresses. View website of AngelWeddingDress.com to find ... wedding dresses online for a bridal party. AngelWeddingDress offers ... for them. Its maternity wedding dresses are specially designed ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David Leadbetter ... to bestow a Juvent Sports Achievement award upon an ... The award commemorated and congratulated McKitrick for her record ... her first amateur tournament in 1979 and most recently ...
Breaking Medicine News(10 mins):Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 2Health News:Chemo Duck Launches First App Ever Created for Kids with Cancer 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3
... , , NEW YORK, Sept. ... received Orphan-Drug designation from the U.S. Food and Drug Administration (FDA) ... that it had reached an agreement with the FDA regarding a ... trial in relapsed/refractory multiple myeloma and that the study is expected ...
... , WEDNESDAY, Sept. 16 (HealthDay News) -- Supervised exercise ... pain, according to a new study. , Shockwave treatment ... a number of studies have suggested that it,s not ... women, aged 18 to 70, who,d had shoulder pain ...
... ATLANTA and LONDON, Sept. 16 ... security services, is streamlining the Payment Card Industry (PCI) ... (ITO) Self-Assessment Questionnaire processes with Predefined Assessment Programs. ... the PCI and FFIEC guidelines. An organization,s ...
... , , NORWALK, Conn., ... protection services, today announced the availability of new features in its IdentitySecure ... types of identity theft: medical identity theft. , , ... personal health records containing inaccurate information are used by health care providers ...
... , , ... and Chief Scientific Officer Dr. Michael Merzenich spoke today as the ... at General Motors Technical Center campus. Dr. Merzenich spoke about the ... to keep driving longer safely and under varied conditions. These clinically-validated ...
... , , , ... HealthLink, Inc., today announced it has changed its business name ... , "We are very excited about the introduction ... Health allows us to better represent our business as we ...
Cached Medicine News:Health News:Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma 2Health News:Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma 3Health News:Keryx Biopharmaceuticals Receives Orphan-Drug Designation for KRX-0401 (Perifosine) for the Treatment of Multiple Myeloma 4Health News:Shockwave Treatment May Not Be Best for Shoulder Pain 2Health News:SecureWorks, Inc. Streamlines the PCI AOC and FFIEC ITO Self-Assessment Questionnaire Processes with Predefined Assessment Programs and Affiliate Compliance Summary Reports 2Health News:SecureWorks, Inc. Streamlines the PCI AOC and FFIEC ITO Self-Assessment Questionnaire Processes with Predefined Assessment Programs and Affiliate Compliance Summary Reports 3Health News:Affinion Security Center Launches Benefits to Help Detect and Resolve Medical Identity Theft 2Health News:Affinion Security Center Launches Benefits to Help Detect and Resolve Medical Identity Theft 3Health News:Brain Training Keeps Older Drivers Safe Behind the Wheel 2Health News:Brain Training Keeps Older Drivers Safe Behind the Wheel 3Health News:Axion Health Inc. Issues Notification of Business Name Change 2Health News:Axion Health Inc. Issues Notification of Business Name Change 3
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: