EOSolutions has announced the submission of a 510(k) application to the US Food and Drug Administration (FDA) for its vascular access solution, Thinline 8F Sheath.
The submission is made through a Design Consulting Firm of the solution.
The new solution has been designed to complement the features of the Dr Banner Balloon Guide Catheter (BGC).
The Thinline Sheath and the Dr Banner BGC work together as a complete system with a 0.091 inner diameter (ID), ensuring compatibility through an 8F sheath profile and serving as a comprehensive toolkit for physicians for easy device delivery.
Using the Thinline Sheath’s optimised design, physicians can provide next-generation large-bore devices such as the Dr Banner BGC, through its 0.125in inner diameter.
Physicians can carry out complex endovascular procedures when the Thinline Sheath is employed along with Dr Banner BGC.
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The Thinline Sheath leverages advanced materials and technology for maintaining lumen integrity. Its reinforced shaft offers better support during catheter manipulations and ensures steady access for accurate procedural control of a range of medical devices.
EOSolutions sales and marketing head and general manager Anthony Parise said: “Acknowledging the concerns related to the next generation 9 Fr systems, we are thrilled to introduce the ThinLine Sheath as a solution.
“This innovative sheath is thoughtfully designed to be compatible with 8 Fr vascular closure systems.
“By combining the remarkable Dr Banner BGC with the ThinLine Sheath, we have created an exceptional 8 Fr system, making the best-in-class .091 in ID Dr Banner BGC even more versatile and accessible for our valued medical professionals.”