50% Reduction in Time-to-Hemostasis Supported by Randomized 376-Patient Clinical Study
MINNEAPOLIS, Oct. 11 -- Vascular Solutions, Inc. (NASDAQ:VASC) today announced that it has received clearance from the U.S. FDA of an expanded indication for its D-Stat Dry hemostatic bandage. As a result of this clearance, the company's direct sales force will be able to promote the D-Stat Dry as a proven method to reduce time-to-hemostasis in patients undergoing diagnostic femoral catheterization procedures.
The expanded indication is supported by the results of a 376-patient, 5-center randomized prospective clinical study that was completed and presented earlier in 2006. The clinical study compared time-to-hemostasis in patients utilizing the D-Stat Dry with similar patients utilizing standard manual compression following diagnostic catheterization via femoral access through 4-6F introducer sheaths. The clinical results documented a 50% reduction in the median time-to-hemostasis using the D-Stat Dry. The clinical results also documented a 0.5% major complication rate with the D-Stat Dry, compared to a 1.5% major complication rate with manual compression.
"This expanded claim based on the randomized clinical study further supports the scientific hemostatic power of thrombin, which is unique to the D-Stat Dry in the patch market," commented Howard Root, Chief Executive officer of Vascular Solutions. "Our new clinical claim will further distinguish the D-Stat Dry from the non-thrombin patches and provide the data requested by a growing number of interventionalists who practice evidence- based medicine."
The D-Stat Dry hemostatic bandage is a proprietary thrombin-based pad together with an adhesive bandage that can be applied for the rapid control of topical bleeding. The D-Stat Dry product was launched in September 2003 and, together with its line extensions, generated $13.8 million in net sales in 2005 and $4.3 million in net sales in the second quarter of 2006.
About Vascular Solutions
Vascular Solutions, Inc. is a medical device company that focuses on developing unique solutions for unmet clinical opportunities within Interventional radiology and Interventional cardiology. New products introduced since the second half of 2003 include the Vari-Lase(R) endovenous laser product line for the treatment of varicose veins, the D-Stat Dry(TM) hemostatic bandage for the rapid control of topical bleeding, the Pronto(TM) extraction catheter for the aspiration of soft thrombus, the Langston(R) dual lumen catheter for the measurement of aortic stenosis and the Twin-Pass(TM) dual access catheter for dual wire access in interventional procedures. The Company's other major products include the Duett(TM) sealing device to rapidly seal the puncture site following catheterization procedures and the D-Stat(R) Flowable hemostat for the local management of active bleeding.
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, 2005 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 profitability, exposure to intellectual property claims, dependence on key vendors, 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.
For further information, connect to www.vascularsolutions.com/.
Source: Vascular Solutions, Inc.
CONTACT: Howard Root, CEO, or James Hennen, CFO, of Vascular Solutions, Inc., +1-763-656-4300
Web site: www.vascularsolutions.com/