Guerbet receives CE mark approval for SeQure and DraKon microcatheters for interventional imaging

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Left: Standard microcatheter, positioned in the artery irrigating the tumor: the embolization microspheres travel not only downstream (desired effect) but also upstream (undesired effect), in an artery irrigating healthy tissues that need to be preserved. Right: Anti-reflux microcatheter: the anti-reflux technology sends all the embolization microspheres downstream into the area to be treated. The healthy tissue continues to be irrigated by blood free of microspheres.

SeQure and DraKon (Guerbet), two novel microcatheters for peripheral embolization procedures, are set for commercial launch in Europe. The devices have received the CE mark for the delivery of intra-arterial therapy and embolic materials into all peripheral vessels.

The SeQure microcatheter is a reflux control microcatheter that, according to a press release, uses flow dynamics to create a fluid barrier designed to deliver more treatment to the target vessel and reduce the risk of non-target embolization, for less potential damage to surrounding tissue. It consists of side slits specifically sized to allow the outflow of contrast media, Guerbet describe, creating a fluid barrier around the microcatheter to reduce microspheres reflux and assist delivery to the target vessel.

The DraKon peripheral microcatheter is the same as SeQure but without the side slits. A press release claims it has been designed to optimise “pushability, flexibility and torqueability for improved trackability and highest performance standards”.

Guerbet obtained both microcatheters as part of their acquisition of Israeli company Accurate Medical Therapeutics, announced in January 2018. The SeQure and DraKon microcatheters received FDA clearance on January 26, 2018 and are currently commercialised on the US market. They are also registered in Hong Kong, New Zealand and Thailand. The registration plan includes Australia, China, India, Japan, Korea, Singapore and Vietnam within the next two years.

SeQure and DraKon are class IIb medical devices intended for use by interventional radiologists and interventional oncologists for the infusion of contrast media into all peripheral vessels and for drug infusion in intra-arterial therapy and infusion of embolic materials. They should not be used in cerebral vessels.

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