Healthcare Industry News:  Balloon catheter 

Devices Interventional Cardiology FDA

 News Release - November 9, 2009

Vascular Solutions Announces 510(k) Clearance and U.S. Launch of GuideLiner Catheter

MINNEAPOLIS, Nov. 9, 2009 -- (Healthcare Sales & Marketing Network) -- Vascular Solutions, Inc. (Nasdaq:VASC ) today announced that it has received 510(k) clearance from the U.S. Food & Drug Administration to launch the GuideLiner(TM) catheter in the United States. The GuideLiner is a unique coaxial "mother and child" guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions' specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions' direct sales force.

Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: "Deep intubation of the GuideLiner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange Balloon catheter and has quickly become a routine part of my angioplasty practice."

Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GuideLiner: "In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the GuideLiner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation."

Howard Root, Chief Executive Officer of Vascular Solutions, commented: "The GuideLiner catheter is a significant new internally-developed addition to Vascular Solutions' line of specialty catheters designed to meet specific needs of physicians performing percutaneous coronary interventions. The initial customer response we have received to our international launch of the GuideLiner makes us very optimistic concerning the potential of this completely unique and proprietary product."

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. Vascular Solutions delivers its proprietary and distributed products to interventional cardiologists, interventional radiologists and vascular surgeons through its direct U.S. sales force and international distributor network.

The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2008 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products, limited working capital, lack of sustained profitability, exposure to intellectual property claims, exposure to possible product liability claims, the development of new products by others, doing business in international markets, limited manufacturing experience, the availability of third party reimbursement, and actions by the FDA.

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Source: Vascular Solutions

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