Tuesday, October 13, 2009

Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve

MINNEAPOLIS and GALWAY, Ireland, Oct. 12, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) and Zerusa Limited today announced that they have received 510(k) clearance with the FDA for the sale of the Guardian(r) II Next Generation hemostasis valve in the United States. Under the terms of an agreement between the two companies from July 2007, Vascular Solutions is the exclusive distributor of the Guardian device in the United States. Zerusa recently began the rollout of its CE marked Guardian II launch through its distribution network in Europe, the Middle East and other markets. Howard Root, Chief Executive Officer of Vascular Solutions, commented: "We're delighted to be able to offer this next generation of the Guardian hemostasis valve to our customers through our 85+ employee direct U.S. sales force. 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." Liam Mulloy, Chief Executive Officer of Zerusa Limited, commented: "We appreciate all the market feedback both from Vascular Solutions and our other partners to date. This has directly led to device enhancements on our Guardian II hemostasis valve - while maintaining the key benefits appreciated by our customers worldwide such as blood loss minimization, management of multiple devices and ease of use. We look forward to building on our relationship with Vascular Solutions to further develop the U.S. market opportunity."
Guardian II - Unique Seal Technology (Click image to enlarge).

  • Provides a cleaner procedural field protecting physicians, staff and patients by reducing the amount of blood in the field.
  • Allows separation of guidewires and other devices during complex procedures.
  • Click-open and Click-close Design
  • Allows single handed operation
  • Unique proximal cap is easily depressed for both opening and closing the lumen.
  • Distinctive wide “bulls eye” opening in the proximal cap allows for easy insertion of devices along with the ability to separate multiple guidewires and other devices during complex cases.

Ergonomic Design
  • Practical design allows the Guardian to fit comfortably in a physician’s hand.
  • Subtle finger tabs have been added for improved handling characteristics.
  • Actual device length 92mm.
  • 8 French Lumen
  • Allows multiple or large therapeutic devices to be inserted during procedures.
  • Secure Device Lock
  • Rotating lock-nut has been designed to provide an additional mechanism for securing device position. Lock-nut functions similar to a tuohy borst™ style valve.

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