Seigla Medical’s guide catheter extension obtains CE Mark
29 April 2021
Seigla Medical has received CE Mark for its LiquID Guide Catheter Extension, which can be used during coronary and peripheral vasculature interventions.
Cardiologists across the globe use these catheter extension tools to aid in the delivery of stents and other interventional devices.
Seigla co-founder, president and CEO Chad Kugler said: “The LiquID device is built on a proprietary and unique technical platform that miniaturises device components, strengthens performance and provides significantly larger internal diameters.
“These attributes help interventionalists perform a wider array of challenging procedures in today’s world of complex intervention.”
Furthermore, the company has completed the first percutaneous coronary intervention (PCI) cases using the LiquID device.
In another development, Contego Medical has received CE Mark for its Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System).
The system comprises a new, next-generation nitinol stent, a pre-positioned post-dilation balloon and an integrated microembolic filter with 40μm pores.
With an asymmetric hourglass design, that is widened at both ends to aid in wall apposition in tortuous anatomy, the closed-cell stent can potentially attain great performance in radial strength, vessel coverage and flexibility. Throughout procedures, the integrated filter of the system can capture both macro- and micro-emboli.
Indicated for adults with clinically significant carotid artery stenosis needing stenting, the system was first analysed in the PERFORMANCE I clinical trial.
In the study, which was carried out on 67 patients at nine European sites with one-year follow up, the Neuroguard IEP System demonstrated a 100% success rate with no stroke and death rate reported in 30 days.
Contego Medical CEO and founder Ravish Sachar said: “CE Marking of the Neuroguard IEP System is an important milestone for Contego Medical and allows us to bring the remarkable safety and performance benefits of the Neuroguard stent to patients in Europe.
“We anticipate launching the product in select countries, as well as initiating a post-marketing clinical study in the coming months.”
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Published on Medicaldevice-network.com