Vascular Solutions’ blood clotting device Guardian II approved in US

Vascular Solutions Inc’s Guardian II hemostasis valve has been given approval for marketing by US FDA.
The Guardian II hemostasis valve is a blood clotting device.

The Guardian II hemostasis valve will be distributed in US by Vascular Solutions partner  Zerusa Ltd, under an agreement between the company for the exclusive distribution of the product.

The valve has been recently launched in Europe, the Middle East and other markets by Zerusa.

The Guardian hemostasis valve is designed to minimize blood loss during percutaneous procedures by providing a seal around guidewires and other devices. Its signature click-open, click-close design facilitates single-handed operation.

The valve allows single-handed operation as its proximal cap is easily depressed for both opening and closing the lumen. Its 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.

Guardian’s unique seal technology allows separation of multiple devices while improving stability—provides protection during complex interventions.

The seal technology is designed to reduce the amount of blood in the field. It allows separation of multiple guidewires and other devices during complex procedures.

The Guardian hemostasis valve is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (0.105”) during the
interventional procedures. The guidewire introducer is included to facilitate the guidewire’s passage through the Guardian hemostasis valve.

Vascular Solutions, Inc is a medical device company focused on bringing clinically advanced solutions to interventional cardiologists and interventional radiologists worldwide.

Vascular Solutions’ main product lines consists of:

1. Hemostat (blood clotting) products, principally consisting of the D-Stat Dry hemostat and the D-Stat Flowable
2. Extraction catheters, principally consisting of the Pronto V3 extraction catheter, a mechanical system for the removal of soft thrombus from arteries
3. Vein products, principally consisting of the Vari-Lase endovenous laser
4. Specialty catheters, consisting of a variety of catheters, including the Langston dual lumen catheters, Twin-Pass dual access catheters, Gandras catheters, and Gopher support catheter
5. Access products, principally consisting of micro-introducer kits, Micro Elite and Expro Elite snares, the Guardian hemostasis valve, and guidewires used in connection with percutaneous access to the vasculature.

For the six months ended 30 June 2009, Vascular Solutions, Inc.’s revenues increased 12% to $33M. Net income totaled $2.3M, Vs. a loss of $233K.

Revenues reflect an increase in income from product and higher revenue from license & collaboration. Net income also reflects a decrease in collaboration expense, lower clinical & regulatory expenses, decreased general &administrative expenses and the absence of litigation expense.