The FDA has granted approval to the Guardian II™ Hemostasis Valve produced by Zerusa, a Galway, Ireland firm. The valve, designed for easy movement of catheters and other interventional angio devices while providing hemostasis, has already been approved in Europe. The device will now be distributed in the US by Vascular Solutions out of Minneapolis, MN.
Features from the product page:
Unique Seal Technology
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.
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.
Here’s a demo animation showing how one operates the device…
Press release: Vascular Solutions and Zerusa Limited Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve…
Product page: Guardian II™…
Guardian II™ brochure…