W. L. Gore & Associates, a US-based multinational manufacturing firm specializing in products derived from fluoropolymers, has secured approval in the US, Japan, and Europe for its polyurethane balloon catheter for endovascular aortic repair.
The Gore Molding & Occlusion Balloon catheter has received approval from the US Food and Drug Administration, Japanese Ministry of Health, Labour, and Welfare, and secured CE mark in Europe.
The catheter designed in partnership with clinicians will assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels.
The new device has been developed to avoid the use of multiple molding and occlusion balloons, enabling to meet all endovascular aortic repair (EVAR) procedural requirements.
The device’s advanced expansion force across the range of EVAR device sizes allows physicians to consistently seat and seal grafts, helping to decrease procedural time and the risk of Type 1 endoleaks.
Designed to reduce access-related complications, the device’s pushability and trackability provides enhanced control with determined inflation and deflation time.
Gore vascular business leader Eric Zacharias said: “We have worked closely with clinicians to engineer a single balloon that truly changes both the physician and the patient experience.
“This milestone is one of several in our ongoing dedication to treating the entire aorta, and to helping physicians offer the best patient experience possible.”
The new device is provided with a single catheter length of 90cm, which will allow to use with current Gore Excluder devices and future devices while still being compatible with 180cm length guidewire.
Zacharias further added: “Use of a single molding and occlusion balloon during an EVAR case reduces intraoperative waste, minimizing overall instrument cost per procedure. The potential to reduce operating room and catheter lab time may contribute to faster room turnover and more on-time procedural starts.”
Gore’s aortic product portfolio includes Gore Excluder AAA endoprosthesis, conformable Gore TAG thoracic endoprosthesis to treat thoracic aneurysms, transections, and Type B dissections.
Gore Excluder Iliac Branch Endoprosthesis is claimed to be the only FDA approved off-the-shelf device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms.
Established in 1958, Gore is a global materials science that serves customers in the aerospace, pharmaceutical and mobile electronics markets, in addition to medical devices segment.