Vascular Solutions Receives 510(k) Clearance for Gel-Block 10x Embolization Product

Vascular Solutions, Inc.

today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for Gel-Block 10x embolization pledgets for use in the treatment of hypervascular tumors and arteriovenous malformations (AVMs). Vascular Solutions is launching the product in the U.S. this week. The Gel-Block 10x version builds on Vascular Solutions' original Gel-Block embolization device launched in the U.S. in July 2012. The new 10x version offers 10 pledgets in a vial as a configuration that enhances value and customer ease-of-use. The original Gel-Block, which will remain available, is packaged with two pledgets per device, pre-loaded into delivery tubes. "For decades, interventional radiologists who wanted to use gelatin foam to embolize a vessel 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. "The introduction of Gel-Block in 2012 replaced this old routine with precisely manufactured and easy-to-use pledgets that provided consistent delivery through standard catheters into the vessel. Now, with our new 10x version of Gel-Block, we have responded to physicians' desire for an option that includes a higher quantity of pledgets with even simpler preparation and the same precise delivery." Gel-Block 10x consists of ten pre-formed, ready-to-use gelatin foam pledgets supplied in a vial with a delivery syringe. The pledgets are designed for precise delivery through standard catheters to occlude blood flow within target vessels. The product is offered in three sizes to accommodate multiple catheter sizes with inner diameters as small as 0.021" and up to 0.038". Vascular Solutions' Gel-Block products were designed to meet the needs of interventional radiologists who previously had been required to cut and roll sheets of gelatin foam to form pledgets for embolization procedures due to the lack of pre-made, off-the-shelf gelatin embolization pledgets. "The launch of Gel-Block 10x will mark the commercialization of our third embolization product, including the original Gel-Block in 2012 and our Gel-Bead™ in June of this year," Mr. Root said. "We have several additional embolization products in our development pipeline designed to meet specific therapeutic needs. All of these products are made possible due to Vascular Solutions' significant biologics expertise and our long-standing commitment to meeting the needs of the interventional radiology market." 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 into the vessel to reduce or stop blood flow.