Submitted by kBLASTER Team on
by Fink Densford for Massdevice.com
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.
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