EOSolutions has announced the US Food and Drug Administration (FDA) 510(k) submission, through a design consulting firm, of the Thinline 8Fr sheath—a vascular access solution designed to complement the “remarkable features” of the company’s Dr Banner balloon guide catheter (BGC).
Together, the Thinline sheath and the Dr Banner BGC provide a full system with a 0.091-inch inner diameter (ID) to ensure maximal compatibility through an 8Fr sheath profile, providing physicians with a comprehensive toolkit and greater freedom for device delivery, an EOSolutions press release states.
According to the company, the Thinline sheath offers a slim, low-profile design that facilitates smooth percutaneous introduction of compatible devices, while its optimised profile enables physicians to safely introduce next-generation large-bore devices, such as the Dr Banner BGC, through its 0.125-inch ID.
“We are delighted to, once again, be responsive to the valuable feedback and needs of our esteemed physicians,” said Anthony Parise, general manager, and head of sales and marketing, at EOSolutions. “Acknowledging the concerns related to the next-generation 9Fr systems, we are thrilled to introduce the Thinline sheath as a solution. This innovative sheath is thoughtfully designed to be compatible with 8Fr vascular closure systems. By combining the remarkable Dr Banner BGC with the Thinline sheath, we have created an exceptional 8Fr system, making the best-in-class 0.091-inch ID Dr Banner BGC even more versatile and accessible for our valued medical professionals.”