Guerbet expands portfolio with microcatheters and guidewires for interventional imaging and embolization

VILLEPINTE, France, March 7, 2022 /PRNewswire/ -- Guerbet (FR0000032526 GBT), a global leader in medical imaging, announces it will more than double its line of microcatheters and launch a new line of guidewires, resulting in a broad range of interventional imaging and embolization solutions available.

The company obtained its original offering of 18 references of SeQure® and DraKon™ microcatheters as part of their acquisition of Accurate Medical Therapeutics in 2018. It received the CE mark in April 2019, and was FDA cleared in 2018. Guerbet now expands the portfolio, adding 20 versions for a total of 38, and launching a new line of Axessio™ guidewires with two diameters. A limited market evaluation began in the United States during the fourth quarter of 2021, paving the way for a commercial launch rollout in Q2 2022 in select markets.

"The positive feedback we've received during the limited market release of our line extension has reinforced Guerbet's decision to expand available tools to the healthcare professionals for various embolization procedures," affirms David Hale, Chief Executive Officer. "This year marks our 40th anniversary in interventional radiology. We're proud of that, but we consider it just the beginning. We've never been more dedicated to continuous growth and innovation to help interventional radiology physicians to meet an even greater number of patient needs."

Both the SeQure® and DraKon™ technologies offer interventional radiologists optimized navigation capabilities which is expected to enable access to difficult anatomies and reach farther. Additionally, SeQure® is the only reflux control microcatheter enabling a fluid barrier technology for flow directed embolization. The new models are designed to deliver more targeted treatment and use a wider range of beads, from extra-small to large^[1],[2].

"Innovation means everything to us, because it means everything to our physician partners and to their patients," explains Jean-François Blanc, Senior VP, Interventional Imaging. "The more we see the results, the more we see opportunity to improve lives, and we just want to keep pushing forward. With strategic acquisitions that helped create a unique toolkit of microcatheters and this latest portfolio extension, we're advancing options for the interventional radiology community."

Guerbet is offering a Digital Launch Event to introduce the line extension on March 12th, 2022. Find information and register for the event, including replays, peer learning, and on-demand content: https://launchevent.guerbet.com 

About Guerbet

At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in five centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €732 million in revenue in 2021. For more information, please visit www.guerbet.com.

About SeQure^®, DraKon™ and Axessio™

DraKon™ and SeQure® microcatheters are class II medical devices in the USA. Outside USA, DraKon™ and SeQure® microcatheters are class IIb medical devices. DraKon™ and SeQure® microcatheters are 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. Notified Body: MedCert 0482. Manufacturer: Accurate Medical Therapeutics Ltd. EC Rep: Guerbet. DraKon™ is trademark and SeQure® is a registered trademark of Guerbet Group or its affiliates.

Axessio™ Guidewire are class II medical devices in the USA. Outside USA, Axessio™ Guidewire are class III medical device intended for use by physicians to introduce percutaneous intravascular catheters. They should not be used in cerebral vasculature, or in patients judged not acceptable for percutaneous intervention (PCI). Notified Body: NSAI 0050. Manufacturer: Brivant Ltd. Distributed in the EU and USA by Guerbet. Axessio™ is a registered trademark of Accurate Medical Therapeutics Ltd. Any performance specifications are believed to be reliable and are the sole responsibility of the legal manufacturer Brivant Ltd.

For complete information about precautions and optimal usage conditions for these medical devices, we recommend consulting the instructions for use supplied with each device or with your local Guerbet representative(s). Information for use only in countries with applicable health authority registrations. Registration and availability may vary according to countries.

CAUTION: US Federal Law restricts these devices to sale by or on the order of a physician. Illustrations for information purposes - not indicative of actual size or clinical outcome.

Forward-looking statements

This press release may contain statements of a forward-looking nature, based on assumptions and predictions 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, financial situation, development and performances of the company, and the estimates made here. These factors include 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-looking statements, or how they correspond to future events or developments.

[1] Test Report TR-056 & TR-072 internal data on file. Beads Compatibility Test Report. Bench Tests results may not necessarily be indicative of clinical performance. 
[2] Test Report TR-057 internal data on file. Beads Reflux Test Report. Bench Tests results may not necessarily be indicative of clinical performance.

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Mars 2022 - I22001139 - GU02220024