Gore has announced FDA 510(k) clearance, approval from the Japanese Ministry of Health, Labour, and Welfare, and receipt of CE mark for the innovative Gore moulding and occlusion balloon, a compliant polyurethane balloon catheter designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels. The new device meets all endovascular aortic repair (EVAR) procedural requirements—a single balloon that replaces the need for multiple moulding and occlusion balloons.
The device’s proven radial expansion force across the range of EVAR device sizes enables physicians to consistently seat and seal grafts with confidence. This more efficient graft seal may reduce procedural time and the risk of type I endoleaks. The device is also engineered with the lowest profile to reduce the potential of access-related complications, and its excellent pushability and trackability offers enhanced control with uncompromised inflation and deflation time.
“We have worked closely with clinicians to engineer a single balloon that truly changes both the physician and the patient experience,” said Eric Zacharias, Gore vascular business leader. “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 supplied in a single catheter length of 90cm to enable use with current Gore Excluder devices as well as future Gore devices while still being compatible with a 180cm length guidewire.
Besides adding value through consistently reliable technical success and patient experience, the use of a single balloon allows for efficiency and inventory optimisation. “We know our physicians are concerned with both technical performance and with economic value to their practices,” Zacharias said. “Use of a single moulding and occlusion balloon during an EVAR case reduces intraoperative waste, minimising 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.”