Guerbet (EPA:GBT) said today that it won CE Mark approval in the European Union for its Sequre and Drakon microcatheters intended for use in peripheral embolization procedures.
The Villepinte, France-based company’s Sequre microcatheter uses flow dynamics to create a fluid barrier designed to deliver treatment to a target vessel to reduce risk of non-target embolization. The device features side slits specifically designed to allow the outflow of contrast media to create a fluid barrier around the microcatheter to reduce microspheres reflux and to aid in delivery to the target vessel.
The newly cleared Drakon peripheral microcatheter is the same as the Sequre device, but does not feature side slits to optimize pushability, flexibility and torqueability, Guerbet said.
Guerbet said that it acquired both microcatheters as part of its $23.7 million acquisition of Accurate Medical Therapeutics, which it announced last January.
“Guerbet is expanding its interventional portfolio with new solutions for interventionalists, to further enhance and secure their embolization cases. This new range of microcatheters will allow us to help interventional radiology community deliver a higher quality of care during image-guided embolization procedures,” commercial interventional imaging VP Thomas Bonnefont said in a press release.
The Sequire and Drakon devices won FDA clearance last January and are already available in the U.S.