Friday, April 15, 2011

Advanced Bionics Aggiornamento Recall

Aggiornamento Advanced Bionics: Non ho capito se torna in Italia, dice che può tornare nei mercati che riconoscono il marchio CE per cambiamenti effettuati nell'impianto HiREs 90K implant, sembra che ancora non torna sul mercato USA.

Press release, Sonova - April 14, 2011
Sonova announces the return of Advanced Bionic’s cochlear implant business
to the European, Asia Pacific, and Latin American Markets

Sonova Holding AG, the world’s leading provider of hearing systems, is
announcing today, that Advanced Bionics (AB), a global leader in developing
advanced cochlear implant systems, has received CE mark approval from the
European Notified Body (TÜV) for changes submitted for the manufacturing of
the HiRes 90K™ implant. Advanced Bionics is in the process of resuming
production and distribution of HiRes 90K implants in all markets that
recognize the CE mark or do not require additional approval.

Prior to the voluntary recall of HiRes 90K™ announced on November 23, 2010,
AB generated approx. 70% of its global sales in these markets. Sonova
expects Advanced Bionics to resume its business in these countries over the
next few weeks.

In addition, AB intends to submit the necessary documentation on the changes
to the manufacturing process to the United States Food and Drug
Administration (FDA) in the coming weeks.

“The CE mark approval is an important milestone for Advanced Bionics to
resume its global business activities” said Alexander Zschokke, acting CEO
of the Sonova Group. “ I am confident that AB will regain its market
position as one of the leading cochlear implant manufacturers very soon.”

As part of AB’s commitment to putting patients first and protecting the
safety of its implant recipients, Advanced Bionics instituted a voluntary
recall of the HiRes 90K cochlear implant in November 2010 as a result of a
very rare technical defect. AB’s investigation continues to show that of the
more than 28,000 implanted HiRes 90K devices, only two devices have been
confirmed to have a technical issue. AB concluded the root cause analysis in
January 2011. Since that time, AB has implemented changes to the
manufacturing process to ensure that no further implants will have this
Sonova will update its expectation of the financial impact of the resumed
business activities of AB at its full year guidance 2011/12 on May 24, 2011.

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