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.
Logo -
https://mma.prnewswire.com/media/1759237/Guerbet_Logo.jpg
Media Relations:
Guerbet Global
ACTIFIN
Marie-Ji-In PRADERE
+33 (0)1 56 88 11 21
mpradere@actifin.fr
Mars 2022 - I22001139 - GU02220024