Navigation Links
Advanced Bionics Reaches Resolution With FDA, Settles Financial Suit
Date:7/18/2008

VALENCIA, Calif., July 18 /PRNewswire/ -- Advanced Bionics agreed to settle an administrative complaint arising from a disagreement with the U.S. Food and Drug Administration (FDA). The FDA asserted that Advanced Bionics should have made a formal submission five years ago before using a second vendor for a particular component in its cochlear implant system. The component, called a feedthru, contained a hidden weakness that allowed a very slow leak of water molecules into the implanted devices containing this vendor's feedthrus while blocking the passage of much smaller helium and nitrogen gases. Until this situation, such a condition was universally believed to be impossible. After an extended period of one year or more, the slow leakage led to device failures, a product recall, and a termination of the second vendor.

Advanced Bionics responded to FDA's complaint asserting the following: (1) it had tested the component with state-of-the-art processes and equipment, which demonstrated that gas molecules much smaller than water molecules were completely blocked from passage; (2) until this hidden weakness was observed, the industry standard testing was considered sufficient to ensure hermeticity; (3) the FDA's own experts in late 2004 mistakenly diagnosed the failure mechanism of the devices containing moisture; (4) Advanced Bionics followed the FDA's guidelines regarding filings with the FDA; and (5) the FDA's approval to market Advanced Bionics' HiRes90K Implantable Cochlear Stimulator was based upon a recognition that the HiRes90K was a repackaging of the previous generation device called CII that used feedthrus from both vendors.

Although the FDA did not accept these arguments, Advanced Bionics believes them to be true and denies that it violated the law. Nevertheless, rather than continuing a protracted and costly legal process that would likely harm its relationship with the FDA, Advanced Bionics has decided to settle this issue and move on
'/>"/>

SOURCE Advanced Bionics
Copyright©2008 PR Newswire.
All rights reserved

1

GOOD

Page: 1 2

Related biology technology :

1. China Biologic Products Honored with the Advanced Technology Certification for Foreign-Funded Enterprises
2. Cynosure Introduces Affirm CO2(TM) Workstation for Advanced Ablative Therapy
3. Advanced Life Sciences Announces Collaboration With UK Ministry of Defence on ALS-886
4. U.S. Genomics Awarded $9.1 Million Contract for Development of Advanced Biosensor by the U.S. Department of Homeland Security
5. Video: New, Advanced Therapy Program Helps People Who Stutter Acquire Fluent Speech
6. NorthPoint Domain and Boston Medical Center Partner to Apply Advanced Patient Engagement Instruments to Pioneering Cardiac Robotic Surgery Program
7. Advanced Life Sciences Added to Russell Microcap Index
8. Culligan's New Aqua-Cleer Advanced Drinking Water SystemProvides Clean, Quality Water Customized for Every Home
9. SACHEM Launches New Products for High Purity Advanced Ceramic Powders : Avanta AC™ Advanced Ceramics Solutions Offer Unique Advantages over Inorganic Bases in the Manufacture of Advanced Ceramic Nanoparticles
10. ABT is the Only Source for Kelo-cote(R) Advanced Formula Scar Gel
11. SACHEM Launches New Products for High Purity Advanced Ceramic Powders : Avanta AC™ Advanced Ceramics Solutions Offer Unique Advantages over Inorganic Bases in the Manufacture of Advanced Ceramic Nanoparticles
Post Your Comments:
*Name:
*Comment:
*Email: