Pryor Medical Devices has received U.S. Food and Drug Administration (FDA) approval for the sale and distribution of its ER-REBOA catheter.
REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) is a minimally invasive technique used by the trauma, critical care and emergency medicine community to temporarily occlude large vessels using a balloon.
‘Features of ER-REBOA include its small 7 french scale size, which precludes the need for extra surgical repair at the access site. The catheter doesn''t require multiple wire exchanges. It also has a soft, atraumatic tip and offers simultaneous arterial pressure monitoring.’
"We are proud to be the first to market with a balloon occlusion catheter designed specifically for this community. They asked for the unique combination of features found on the ER-REBOA catheter, and we look forward to getting it to them," said David A. Spencer, CEO of Pryor Medical Devices.
Features of ER-REBOA include its small 7 French scale size, which precludes the need for extra surgical repair at the access site. The catheter doesn't require multiple wire exchanges. Most importantly, it also has a soft, atraumatic tip and offers simultaneous arterial pressure monitoring.
The medical device company has scheduled first delivery of its catheters for January 1, 2016.