Minimally-invasive vascular trauma focused Pryor Medical Devices said today it won FDA 510(k) clearance for its ER-Reboa balloon catheter designed to occlude the aorta.
The ER-Reboa is San Antonio, Texas-based Pryor’s flagship product, designed to occlude large vessels using a balloon for treating traumatic injuries, specifically by the critical care and emergency medicine community.
“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,” CEO David Spencer said in a press release.
The ER-Reboa is 7 Fr in size, which the company said “precludes the need for additional repair at the access site.” The device comes equipped with a soft, atraumatic arterial pressure monitoring tip and doesn’t require multiple wire exchanges, Pryor Medical said.
Pryor Medical said it scheduled the 1st delivery of the device for January 1, 2016.
The company said it is developing multiple next-generation Reboa catheters and other minimally invasive solutions for the vascular market.