Vascular Solutions Gets 510(k) Clearance For Gel-Block 10x

(RTTNews) - Vascular Solutions, Inc. (VASC) Tuesday said its product Gel-Block 10x received 510(k) clearance from the U.S. Food and Drug administration, for use in the treatment of hypervascular tumors and arteriovenous malformations.

Vascular Solutions helps in embolization, a process that purposely blocks blood flow in a particular region for diagnostic reasons.

The device is an upgrade on the original Gel-Block device launched in July 2012, in US, and offers ten pledgets per device packed in a vial. This is to be compared with two pledgets per device in the original version.

Gel-Block 10x comes in three different sizes to accommodate varied catheter sizes ranging from 0.021 inches to 0.038 inches.

This will be the third embolization device to be launched by Vascular Solutions, following the original Gel-Block Version, and Gel-Bead, which was launched in June, the company said.