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CryoLife receives EU approval for new BioFoam indication
CryoLife has announced that its BioFoam Surgical Matrix has received regulatory approval in Europe for a new indication.
The product has been ratified as an adjunct to haemostasis in cardiovascular surgery when cessation of bleeding by ligature or other conventional methods is deemed ineffective or impractical.
BioFoam is already available in Europe in addition to haemostasis for the sealing of abdominal parenchymal tissues, with CryoLife noting that early clinical experience in this field has been encouraging.
Steven Anderson, CryoLife's president and chief executive officer, said: "This expanded indication aligns with our BioGlue and PerClot market opportunity in Europe, giving us another sales driver and product to add to our selling efforts for our core cardiovascular surgeon customers."
The company expects to generate more than $100 million (62.44 million pounds) in annual European sales of BioFoam, BioGlue and PerClot.
CryoLife is experiencing a strong performance in financial terms this year, with revenue in the third quarter experiencing a 13 percent year-over-year increase.
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