Navigation Links
Global Regulatory Milestones for Invibio Biomaterial Solutions
Date:3/14/2013

Thornton-Cleveleys, UK (PRWEB) March 14, 2013

Invibio Biomaterial Solutions' innovative PEEK-OPTIMA® family of biomaterials – including the world's first implantable grade polyetherketone (PEEK) polymer – have achieved considerable regional regulatory milestones, particularly significant in the current regulatory climate, it was announced today by Invibio director of Regulatory Affairs, Craig Valentine. As of February 2013, the number of implantable medical devices manufactured from PEEK-OPTIMA and cleared for market in the US reached 500, with more than 80 approved for market in China*.

“The regulatory environment globally is more challenging than ever. Support of data and knowledge through the process can help device companies overcome regulatory barriers. We are committed to continuing our investments in resources to support medical device companies’ regulatory submissions across global markets. Invibio maintains a Drug & Device Master file data at the US FDA and has specific test data required for both China and Japan available to customers on file. This data is utilized by the regulatory authorities and provides the verification of PEEK-OPTIMA’s biocompatibility and biostability, which is supported by a dedicated global regulatory team,” said Valentine.

Valentine noted “As medical device companies look for growth in BRIC countries, as evidenced by recent market acquisitions, knowledge and experience of the regulatory pathway is an advantage to speeding access to market”. The steady rise in the medical device industry's use of PEEK-OPTIMA in spine as well as other applications is mirrored elsewhere around the globe as well with PEEK-OPTIMA based implantable medical devices approved in all the BRIC emerging markets

In 1999 PEEK-OPTIMA became the first-ever biomaterial to replace the use of metal in spinal applications, when it was incorporated into an interbody fusion cage. Today, PEEK-OPTIMA interbody fusion devices are the standard of care in both lumbar and cervical fusion, and device manufacturers have selected PEEK-OPTIMA for use in other spinal applications including TDR (total disc replacement), spinal rods and interspinous devices.

"As demonstrated by these global regulatory milestones, PEEK-OPTIMA continues to set an industry standard for biomaterials biocompatibility and quality. Invibio’s commitment to advancing medical device design innovation does not stop at our biomaterial capabilities. Our strong strategic alliances within the research and surgical community and across the global medical device industry, combined with our depth and breadth of biomaterials, and manufacturing capabilities enable Invibio to partner with our customers to access and accelerate their time to market in a challenging environment,” said Valentine.

Since 1999, the versatile family of PEEK-OPTIMA polymers have steadily gained market acceptance. Today these market-leading biomaterials are extensively used in over four million medical devices worldwide. The applications span trauma (plates, nails and screws for example); arthroscopy (for anchors and interference screws); orthopedic (for structural components and finger, hip and knee components); cranial plates; dental; cardio, neurological and bariatrics.

About Invibio
Invibio® is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, MOTIS® polymer, ENDOLIGN® composite and PEEK-CLASSIX® polymer for the development of long- and short-term implantable medical devices.

For more information, please contact Invibio at: 866 468 4246 or +484 342 6004 (U.S.), +44 (0) 1253 898000 (U.K.), +852 2366 4448 (Asia Pacific) or online at http://www.invibio.com. info(at)invibio(dot)com

*Data on file at Invibio

Read the full story at http://www.prweb.com/releases/Invibio/PEEK-OPTIMA/prweb10522809.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Guidepoint Global Launches Two Major Enhancements to its Client Research Portal
2. Peptide Therapeutics Market is Expected to Reach USD 25.4 Billion Globally in 2018: Transparency Market Research
3. Global Implantable Drug Delivery Devices Market - New Industry Research Report Published by Transparency Market Research
4. Global Acrylonitrile Butadiene Styrene Market (ABS) - New Industry Research Report Published by Transparency Market Research
5. EtQ to Host Life Science Summit on the World of Quality and Global Supply Chain
6. Atlantica Group LLC to Support Global Business Incubation and "Soft Landing" Efforts
7. Infotrieve Hires Mary Ging, Global Publishing Expert, to Lead EU Office
8. Array Biopharma and Global Blood Therapeutics Announce Drug Discovery Collaboration Focused on Hematology
9. Radiopharmaceuticals Market - Global Industry Analysis, Size, Share, Trends And Forecast, 2012 - 2018: MarketResearchReports.Biz
10. Comprehensive Global Testing Solutions for Novel Hepatitis C Therapeutics, New Webinar Hosted by Xtalks
11. Alexandria Real Estate Equities, Inc. Announces Long-Term Lease with Leading Global Commercial-Stage Oncology Company, Onyx Pharmaceuticals, Inc., for New Build-to-Suit Facility in South San Francisco, California
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... UAS LifeSciences, ... launch of their brand, UP4™ Probiotics, into Target stores nationwide. The company, which ... to add Target to its list of well-respected retailers. This list includes such ...
(Date:6/23/2016)... June 23, 2016 Houston Methodist Willowbrook ... Cy-Fair Sports Association to serve as their official ... Houston Methodist Willowbrook will provide sponsorship support, athletic ... with association coaches, volunteers, athletes and families. ... Cy-Fair Sports Association and to bring Houston Methodist ...
(Date:6/23/2016)... FRANCISCO , June 23, 2016   EpiBiome ... has secured $1 million in debt financing from Silicon ... ramp up automation and to advance its drug development ... its new facility. "SVB has been an ... beyond the services a traditional bank would provide," said ...
(Date:6/23/2016)... , June 23, 2016 Apellis Pharmaceuticals, ... 1 clinical trials of its complement C3 inhibitor, ... and multiple ascending dose studies designed to assess ... of subcutaneous injection in healthy adult volunteers. ... either as a single dose (ranging from 45 ...
Breaking Biology Technology:
(Date:6/15/2016)... New York , June 15, 2016 /PRNewswire/ ... a new market report titled "Gesture Recognition Market by ... and Forecast, 2016 - 2024". According to the report, ... USD 11.60 billion in 2015 and is estimated ... reach USD 48.56 billion by 2024.  ...
(Date:6/2/2016)... , June 2, 2016 The ... has awarded the 44 million US Dollar project, for ... Embossed Vehicle Plates including Personalization, Enrolment, and IT Infrastructure ... leader in the production and implementation of Identity Management Solutions. ... January, however Decatur was selected for ...
(Date:5/20/2016)... , May 20, 2016  VoiceIt is excited ... with VoicePass. By working together, VoiceIt ...  Because VoiceIt and VoicePass take slightly different approaches ... increases both security and usability. ... about this new partnership. "This marketing ...
Breaking Biology News(10 mins):