Medical technology company Medtronic has secured CE mark approval for its radial artery access products such as the Rist 079 radial access guide catheter and the Rist radial access selective catheter.
The Rist 079 radial access guide catheter is claimed to be the first catheter specifically designed to meet the unique requirements of accessing the neuro vasculature via the radial artery versus access through the transfemoral artery.
Medtronic already secured 510(k) clearance from the US Food and Drug Administration (FDA) for the Rist 079 catheter. It is in use at limited sites in the US.
The company has designed the Rist 079 catheter to introduce interventional devices into the peripheral, coronary, and neuro vasculature.
The Rist Radial access selective catheter is also designed for the similar purpose.
The device also enables the introduction of diagnostic agents in the neuro vasculature, but not indicated to facilitate introduction of diagnostic agents in coronary or peripheral arteries.
Since a suggestion made by the American Heart Association in 2018 for the use of a radial-first approach for acute coronary syndrome, transradial techniques have now become the standard of care in the cardiac interventional community.
The approach was suggested due to lower bleeding and vascular complications than transfemoral artery access.
Medtronic neuroscience portfolio’s neurovascular therapies business president Dan Volz said: “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.
“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.”
In May this year, Medtronic secured CE mark approval for its InPen smart insulin pen for multiple daily injections (MDI).
