Zerusa Limited and Vascular Solutions, Inc. announced that they have received 510(k) clearance with the FDA for the sale of the Guardian® II Next Generation hemostasis valve in the United States.
Zerusa Limited and Vascular Solutions Announce FDA Market Clearance for the Next Generation Guardian II Hemostasis Valve
Zerusa Limited and Vascular Solutions, Inc. announced that they have received 510(k) clearance with the FDA for the sale of the Guardian® 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.”
About Zerusa Limited
Zerusa Limited designs, develops and markets minimally invasive medical devises for the diagnosis and treatment of vascular disease.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of five major categories: hemostat (blood clotting) products, extraction (clot removal) catheters, vein products, specialty catheters and access products.