Vascular Solutions Launches Gel-Block(TM) Embolization Product
- Catheter-delivered gelatin pledgets target treatment of hypervascular tumors and arteriovenous malformations (AVMs)
- Pre-formed, radially-compressed Gel-Block eliminates the need for physicians to cut and manufacture their own embolization pledgets
- Improvement in precision of sizing, consistency of delivery, and ease-of-use in common interventional radiology procedures
MINNEAPOLIS, July 9, 2012 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (VASC) today announced that it has launched its Gel-Block embolization pledgets in the United States for use in the treatment of hypervascular tumors and arteriovenous malformations (AVMs). The company believes its new Gel-Block product represents a major improvement in the precision of sizing, consistency of delivery, and ease-of-use over current embolization practice.
Gel-Block consists of pre-formed, radially-compressed, and precisely-sized pledgets of gelatin foam that are packaged into ready-to-use delivery tubes for delivery through standard catheters to occlude flow. Gel-Block, which received 510(k) clearance from the U.S. Food and Drug Administration in May, was designed to meet the needs of interventional radiologists who until now have been required to cut and roll sheets of gelatin foam to form pledgets for embolization procedures due to the lack of an available pre-made gelatin embolization pledget.
"For decades, interventional radiologists who wanted to use gelatin foam to embolize a vessel have had to follow the imprecise and time-consuming routine of cutting and forming their own pledgets," said Howard Root, Chief Executive Officer of Vascular Solutions. "Gel-Block replaces this old routine with three precisely manufactured and easy-to-use sizes of pledgets that provide consistent and maximized swell when delivered through standard catheters into the vessel."
"The launch of Gel-Block was made possible because of Vascular Solutions' significant biologics expertise and is consistent with our commitment to meeting the needs of the interventional radiology market. Gel-Block is the first of several planned new product offerings for embolization procedures," Mr. Root said.
Embolization is the technique of deliberately blocking blood flow within a vein or artery to achieve a therapeutic effect. Standard catheters are used to reach the targeted treatment area, and then a blocking agent is injected within the vessel to reduce or stop blood flow. Procedures that involve the use of temporary embolic materials include blocking flow to hypervascular tumors and AVMs.
Gel-Block is available in three sizes, which are matched for delivery through standard catheters with inner diameters as small as 0.021". Each pledget is formed through a high-pressure, mechanical radial crimping process that results in a precisely compressed cylinder that can be delivered through a small lumen but then almost immediately expands to five times its compressed size upon contact with blood. This radial crimping process ensures that upon expansion, the width of the pledge will grow but not the length, which allows for controlled and predictable delivery within the vessel. Gel-Block is awaiting CE Mark and other foreign registrations for international launch.
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 over 60 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent 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, 2011 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, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com .
CONTACT: James Hennen, CFO Phil Nalbone, VP Vascular Solutions, Inc. (763) 656-4300Source: Vascular Solutions, Inc. 2012 GlobeNewswire, Inc.