DUBLIN, Sept. 28, 2021 /PRNewswire/
-- Medtronic plc (NYSE:MDT), the global leader in
medical technology, today announced it has received CE Mark
approval for its radial artery access portfolio, which
includes the Rist™ 079 Radial Access Guide Catheter and Rist™
Radial Access Selective Catheter.
The Rist 079 Radial Access Guide Catheter is the first
catheter specifically designed for the unique demands of accessing
the neuro vasculature through the radial artery versus access
through the transfemoral artery. 510(K) cleared by United
States Food and Drug Administration1, the product has
been in use at limited sites in the U.S. and received strong
customer feedback in over 100 cases on its outperformance in
navigability and support for the radial pathway.
"With excellent navigability, this first-of-its-kind device will
allow clinicians to reach distal locations while still achieving
excellent stability to the system," said Dr. Alejandro Tomasello, head of Interventional
Neuroradiology Unit at Vall d'Hebron Hospital, Barcelona, Spain. "The radial artery-access
portfolio works well in tandem with Phenom™ PLUS, Phenom™ 021
microcatheter for stent deployment or Phenom™ 027 microcatheter for
flow diverter deployment, which is a fantastic set up for Pipeline™
VANTAGE Embolization Device with Shield Technology™
treatments."
Transradial techniques are now the standard of care in the
cardiac interventional community since the American Heart
Association recommended a radial-first approach for acute
coronary syndrome in 2018 citing lower bleeding and vascular
complications than transfemoral artery access2,3. Other
advantages demonstrated in cardiovascular procedures to radial
access include strong patient preference4, immediate
ambulation and reduced costs5,6, which have led the
neuro-interventionalist community to examine adoption of the
transradial approach to their practice.
"We are committed to exploring ways to improve outcomes through
complication reduction, reducing the cost of care and improving the
overall patient experience. We believe radial access is a
meaningful addition to the clinical armamentarium," said
Dan Volz, president of the
Neurovascular Therapies business, which is part of the Neuroscience
Portfolio at Medtronic. "The CE Mark approval of the Rist radial
access portfolio emphasizes our focus on driving innovation that
gives clinicians who perform neurovascular procedures the broadest
product portfolio so they can customize their care based on a
patient's condition and anatomy."
About the Rist™ Radial Access Catheters
The Rist 079
Radial Access Guide Catheter is indicated for the introduction of
interventional devices into the peripheral, coronary, and neuro
vasculature.
The Rist Radial Access Selective Catheter is indicated for the
introduction of interventional devices into the peripheral,
coronary and neuro vasculature. It can be used to facilitate
introduction of diagnostic agents in the neuro vasculature. It is
not intended to facilitate introduction of diagnostic agents in
coronary or peripheral arteries.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
- Rist Neurovascular Inc. 510(k) K191551 and K201682
- Mason, Peter, et al. JACC Cardiovasc Interv. 2018, 11.
- Ferrante G, et al. JACC Cardiovasc Interv.
2017;9(14):1419-1434.
- Amin AP, et al. JACC Cardiovasc Interv. 2013;6(8):827-834.
- Cooper CJ, et al. Am Heart J. 1999;138(3):430-436.
- Amaroso G, et al. Eur J Cardiovasc Nurs. 2006;5(1):3-4.
See the device manual for detailed information regarding the
instructions for use, indications, contraindications, warnings,
precautions, and potential adverse events. For further information,
contact your local Medtronic representative and/or consult the
Medtronic website at medtronic.com.
Contacts:
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David T.
Young
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Ryan
Weispfenning
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Public
Relations
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Investor
Relations
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+1-774-284-2746
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+1-763-505-4626
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SOURCE Medtronic plc