W.L. Gore & Assoc. said today that its molding & occlusion balloon won a trifecta of regulatory nods in the U.S., Japan and Europe.
The Flagstaff, Ariz.-based company said the device is designed to deliver stent grafts or temporarily occlude large-diameter vessels during endovascular aortic repair procedures. In addition to 510(k) clearance from the FDA, the balloon won CE Mark approval in the European Union and a nod from Japan’s Ministry of Health, Labor & Welfare.
It’s designed to be compatible both with Gore’s Excluder stent graft and any future such devices Gore puts on the market, the company said.
“We have worked closely with clinicians to engineer a single balloon that truly changes both the physician and the patient experience,” vascular business leader Eric Zacharias said in prepared remarks. “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.
“We know our physicians are concerned with both technical performance and with economic value to their practices,” Zacharias said. “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.”