April 23, 2019
Guerbet's SeQure and DraKon Microcatheters Approved in Europe
April 24, 2019—Guerbet LLC announced CE Mark approval and the upcoming European launch of its SeQure and DraKon microcatheters for peripheral embolization procedures. The devices are indicated for the delivery of intra-arterial therapy and embolic materials into all peripheral vessels.
Guerbet advised that the SeQure and DraKon microcatheters received FDA clearance on January 26, 2018, and are commercially available in the United States. They are also registered in Hong Kong, New Zealand, and Thailand. The company plans to obtain registration in additional international markets within the next 2 years.
In January 2018, Guerbet, which is based in France, obtained both microcatheters as part of the company's acquisition of Israel-based Accurate Medical Therapeutics.
According to the company, the SeQure microcatheter is a reflux-control microcatheter that uses flow dynamics to create a fluid barrier designed to deliver more treatment to the target vessel and reduce the risk of nontarget embolization for less potential damage to surrounding tissue. The device has side slits that are sized to allow the outflow of contrast media, which creates a fluid barrier around the microcatheter to reduce microsphere reflux and assist delivery to the target vessel.
The DraKon peripheral microcatheter is the same as SeQure but without the side slits. It is designed to optimize pushability, flexibility, and torqueability for improved trackability and performance.
Both microcatheters feature enhanced navigation capabilities to enable access to difficult anatomies and reach farther.
SeQure and DraKon are intended for use by interventionalists for the infusion of contrast media into all peripheral vessels, drug infusion in intra-arterial therapy, and infusion of embolic materials. They should not be used in cerebral vessels, advised the company.