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FDA grants approval for Vascular Solutions’ embolization product Gel-Block 10x

Medical device company Vascular Solutions has obtained 510(k) approval from the US Food and Drug Administration for Gel-Block 10x embolization pledgets to treat hypervascular tumors and arteriovenous malformations (AVMs).

The Gel Block 10x has been developed based on the original Gel-Block embolization device launched in the US in 2012.

The new 10x version offers 10 pledgets in a vial, while the original Gel-Block will remain available with two pledgets per device, pre-loaded into delivery tubes.

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 CEO Howard Root said: "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.

"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."

Vascular said that the product will be launched in the US this week.

Embolization is a technique in which blood flow is deliberately blocked within a vein or artery to achieve a therapeutic effect.