Monday, medical device makers Vascular Solutions, Inc. (VASC) and Zerusa Ltd. revealed U.S. Food and Drug Administration clearance to market Guardian II Next Generation hemostasis valve in the U.S. VASC shares gained more than 17% following the news.
Section 510(k) of the United States Federal Food, Drug, and Cosmetic Act requires device makers to notify the FDA regarding their intent to market a medical device. The device is then tested to prove that it is "substantially equivalent" to a device already in the market and issued 510(k) clearance by the FDA.
Minneapolis, Minnesota-based Vascular Solutions is the exclusive distributor of the Guardian device in the U.S., according to an agreement between the two companies in July 2007.
Ireland-based Zerusa has begun rolling out CE-marked Guardian II through its distribution network in Europe, the Middle East, and other markets.
Howard Root, chief executive officer of Vascular Solutions, said, "The device enhancements contained in this new device are well suited to our U.S. customers, and we're looking forward to making an expanded impact with this product in the marketplace."
VASC closed Monday's regular trading at $8.35, up $0.07 or 0.85%, on a volume of 29 thousand shares on the Nasdaq. In after hours, the stock is gaining $1.85 or 22.16%.
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