Tuesday April 14, 3:32 pm Eastern Time
Company Press Release
SOURCE: Bio-Vascular, Inc.
Bio-Vascular, Inc., Receives FDA Clearance for CV Peri-Guard Product
ST. PAUL, Minn., April 14 /PRNewswire/ -- Bio-Vascular, Inc. (Nasdaq: BVAS - news) announced today that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for CV Peri-Guard(TM), a cardiovascular reconstruction material.
As the newest member of Bio-Vascular's Tissue Guard product family, CV Peri-Guard is intended to be used by cardiac surgeons as a reconstruction material for intracardiac defects, great vessels, septal defects, and annulus repairs, as well as suture-line buttressing.
''Our tissue is highly effective in cardiac repair, and we now will be able to market it for these applications,'' said M. Karen Gilles, president and chief executive officer. ''We believe this to be a $20 million market worldwide. Sales of the CV Peri-Guard product are expected to begin in the quarter starting May 1.''
Gilles said the company intends to seek regulatory approval in the future for a pediatric version of the cardiac patch.
Bio-Vascular, Inc., based in St. Paul, develops, manufactures and markets proprietary specialty medical products for use in thoracic, cardiac, neuro ophthalmic and vascular surgery.
SOURCE: Bio-Vascular, Inc.
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