Villepinte, France, April 24th, 2019 - Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, announces the upcoming European launch of SeQure® and DraKon™, two novel microcatheters for peripheral embolization procedures. SeQure® and DraKon™ microcatheters received the CE mark 7436GB410190416 on April 16th, 2019 for the delivery of intra-arterial therapy and embolic materials into all peripheral vessels.
The SeQure® microcatheter is an innovative reflux control microcatheter that uses flow dynamics to create a fluid barrier designed to deliver more treatment to the target vessel1 and reduce the risk of non-target embolization2,3, for less potential damage to surrounding tissue. It consists of side slits which size has been specifically designed to allow the outflow of contrast media, creating a fluid barrier around the microcatheter to reduce microspheres reflux and assist delivery to the target vessel.
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.
Reflux control microcatheter: the reflux control 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.
The DraKon™ peripheral microcatheter is the same as SeQure® but without the side slits. It has been designed to optimize pushability, flexibility and torqueability for improved trackability and highest performance standards4,5,6.
Both the SeQure® and DraKon™ technologies offer interventional radiologists enhanced navigation capabilities to enable access to difficult anatomies and reach farther.
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 commercialized on the US market. They are also registered in Hong Kong, in New Zealand and in Thailand. The registration plan includes Australia, China, India, Japan, Korea, Singapore and Vietnam within the next 2 years.
References:
1. Beads accumulation reports DR-1800178 & TR-02601
2. Vessel Flow Dynamic Indication (Beads Reflux) Bench Test report TR-002
3. Usability, Safety and Efficacy of a Novel Microcatheter for Reducing Non-Target Embolization. Michael Tal et al. WCIO 2018 Poster. Animal study
4. TR-025 Flexibility Bench Test
5. TR-006 Torque Transmission Bench Test
6. TR-017 Trackability Bench Test
Press release
About Guerbet
Guerbet is a pioneer in the contrast-agent field, with more than 90 years' experience, and is a leader in medical imaging worldwide. It offers a comprehensive range of pharmaceutical products, medical devices and services for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients. With 8% of revenue dedicated to R&D and its four centers in France, Israel and the United States, Guerbet is a substantial investor in research and innovation. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €790 million in revenue in 2018. For more information about Guerbet, please visit www.guerbet.com.
About SeQure® and DraKon™
SeQure® and DraKon™ are class IIb medical devices intended for use by interventional radiologistsand interventional oncologists for the infusion of contrast media into all peripheral vessels and for druginfusion in intra-arterial therapy and infusion of embolic materials. They should not be used in cerebralvessels. For complete information about precautions and optimal usage conditions for these medicaldevices, we recommend consulting the instructions for use. Notified Body: MedCert 0482. Manufacturer:Accurate Medical Therapeutics Ltd. EC Rep: Guerbet. SeQure® and DraKon™ are registered trademark of Guerbet Group or its affiliates.
Forward-looking statements
This press release may contain statements of a forward-looking nature, based on assumptions andpredictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financialsituation, development and performances of the company, and the estimates made here. These factorsinclude those mentioned in the public reports of Guerbet, available on its website www.guerbet.com. The company assumes no responsibility whatsoever in relation to the updating of these forward-lookingstatements, or how they correspond to future events or developments.