EOSolutions Corporation has announced that the US Food and Drug Administration (FDA) has cleared its Thinline introducer sheath—an approval that swiftly follows the successful launch of the company’s “revolutionary” Dr Banner balloon guide catheter (BGC) in the USA.
The Thinline sheath has been “meticulously engineered” to complement the Dr Banner BGC device, offering an innovative solution to the challenges associated with large-bore BGCs, as per an EOSolutions press release.
“I really enjoy using the Dr Banner balloon guide catheter,” said Italo Linfante (Florida International University, Miami, USA). “It is very supportive and its large ID [inner diameter] provides significant aspiration. Most important is the very soft, compliant balloon. It immediately conforms to the vessel wall, confirming vessel occlusion. With the clearance of the Thinline introducer sheath, I now have the option to choose an 8Fr closure system, if needed.”
According to EOSolutions, the Dr Banner BGC sets “a new standard” in the industry, with its 0.091-inch ID providing the largest BGC lumen available, translating to superior flow when aspirating and enhanced visualisation during contrast runs.
Dr Banner’s unique balloon material composition ensures “exceptional conformability” to the vessel wall, reducing stress pressure during inflation and the potential for vessel distention, the company further claims. Its reinforced stainless steel, co-axial design with alternating transition zones optimises trackability while delivering “unparalleled proximal support”, and rapid inflation and deflation times.
“We are delighted to receive FDA clearance for the EOSolutions Thinline introducer sheath,” said Anthony Parise, general manager of EOSolutions. “This sophisticated solution reduces the required closure size to just 8Fr, enabling seamless integration with the Dr Banner balloon guide catheter and expanding the possibilities for physicians with our innovative offerings.”