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Contego Medical erhält CE-Zulassung für Karotisstent der nächsten Generation
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News provided by

Contego Medical, Inc.

Apr 17, 2021, 12:23 ET

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RALEIGH, North Carolina, 17. April 2021 /PRNewswire/ -- Contego Medical, Inc., ein führender Entwickler innovativer kardiovaskulärer Geräte, gab heute den Erhalt der CE-Zulassung für das Neuroguard IEP® 3-in-1 Karotisstent- und Postdilatationsballon-System mit integriertem Embolieschutz (Neuroguard IEP System) bekannt.

Das patentierte Neuroguard IEP-System enthält einen neuartigen Nitinol-Stent der nächsten Generation, einen vorpositionierten Postdilatationsballon und einen integrierten mikroembolischen Filter mit 40 μm Poren. Der geschlossenzellige Stent wurde entwickelt, um eine optimale Leistung in Bezug auf radiale Festigkeit, Gefäßabdeckung und Flexibilität zu erzielen. Er verfügt außerdem über ein einzigartiges asymmetrisches Sanduhr-Design, das an beiden Enden aufgeweitet ist, um die Wandapposition in gewundenen Anatomien zu erleichtern. Der integrierte Filter ist so konzipiert, dass er sowohl Makro- als auch Mikroembolien während des gesamten Eingriffs erfasst. Das Neuroguard IEP-System ist für erwachsene Patienten mit klinisch signifikanter Karotisstenose, die einen Stent erfordert, indiziert.

Das Neuroguard IEP-System wurde erstmals in der klinischen Studie PERFORMANCE I evaluiert. Die Studie wurde an neun europäischen Studienzentren durchgeführt und umfasste 67 Patienten mit einer Nachbeobachtungszeit von einem Jahr. Die Gesamterfolgsrate betrug 100 % mit einer Schlaganfall- und Todesrate von 0 % nach 30 Tagen1.

„Die CE-Kennzeichnung des Neuroguard IEP-Systems ist ein wichtiges Ziel für Contego Medical und ermöglicht es uns, die bemerkenswerten Sicherheits- und Leistungsvorteile des Neuroguard-Stents Patienten in Europa zugänglich zu machen", sagte Dr. Ravish Sachar, CEO und Founder von Contego Medical. „Wir gehen davon aus, dass wir das Produkt in ausgewählten Ländern einführen und in den kommenden Monaten eine klinische Post-Marketing-Studie starten werden."

Stacy Enxing Seng, Venture Partner, Lightstone Ventures, und Contego Medical Vorstandsvorsitzende, kommentierte: „Der Erhalt der CE-Zulassung für das Neuroguard IEP System ist ein bedeutender Erfolg für das Team von Contego Medical und steht für eine mehrjährige Investition in innovative Produktentwicklung und hochwertige klinische Forschung. Ich bin davon überzeugt, dass das Neuroguard IEP System die Leistungsfähigkeit und Benutzerfreundlichkeit besitzt, um zum Standard bei der Behandlung von Erkrankungen der Halsschlagader zu werden."

Informationen zu Contego Medical
Contego Medical, Inc. ist ein medizintechnisches Unternehmen, das sich der Entwicklung neuartiger medizinischer Geräte für kardiovaskuläre und periphere Gefäßverfahren widmet. Die Integrated Embolic Protection (IEP)-Plattform des Unternehmens, die Embolieschutz und -behandlung in einem Gerät vereint, wurde entwickelt, um katheterbasierte Verfahren zu vereinfachen und die Patientenergebnisse zu verbessern.

In den USA ist das Neuroguard IEP System ein Prüfapparat, der nach US-amerikanischem Recht nur zu Prüfzwecken verwendet werden darf.

Neuroguard IEP und das Contego Medical Logo sind eingetragene Handelsmarken von Contego Medical, Inc. Das Neuroguard System ist durch die US-Patente 9,968,472 und 10,932,929 und das europäische Patent EP 3,367,967 geschützt. Weitere US- und ausländische Patente sind angemeldet.

1 LINC 2020

SOURCE Contego Medical, Inc.

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