W.L. Gore & Associates has won approvals and clearances from a wide variety of regulatory bodies for its Molding and Occlusion Balloon. The technology has received FDA clearance; a CE mark; and approval from the Japanese Ministry of Health, Labour, and Welfare.
The Flagstaff, AZ-based company’s device is a compliant polyurethane balloon catheter. The Molding and Occlusion Balloon was designed in close collaboration with clinicians to assist in the expansion of self-expanding stent grafts or to temporarily occlude large-diameter vessels.
Gore said the new device meets all endovascular aortic repair (EVAR) procedural requirements and is a single balloon that replaces the need for multiple molding and occlusion balloons.
Plans now call for the company to focus on launching the device in multiple markets.
“I think pretty rapidly we’ll be looking at a global launch that will tier out, with the first in-human use likely being in Japan,” Eric Zacharias, Gore Vascular Business Leader, told MD+DI. “Then from there we will work to fill our supply chain and transition our current offering to this design.”
Approvals and clearances of the Molding and Occlusion Balloon are a few months removed from Gore receiving an FDA nod to expand the indication of the Cardioform Septal Occluder to reduce the risk of recurrent ischemic stroke in patients.
FDA's nod allowed Gore’s Cardioform to effectively compete against Abbott Laboratories’’ Amplatzer technology.
The expanded indication was supported by the REDUCE study. Results from REDUCE were published in the New England Journal of Medicine in September 2017 and presented at the European Stroke Organization Conference (ESOC) last May.