Pryor Medical wins FDA 510(k) for aortic balloon catheter
San Antonio, TX ., Pryor Medical Devices (The REBOA CompanyTM), today announced it has received FDA 510(k) clearance for the sale and distribution of its ER-REBOATMcatheter. 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.
“We are proud to be the first to market with a balloon occlusion catheter designed specifically for this community,” said David A. Spencer, CEO of Pryor Medical Devices. “They asked for the unique combination of features found on the ER-REBOA catheter, and we look forward to getting it to them.”
Key ER-REBOA features of interest include its small 7 Fr size, which precludes the need for additional surgical repair at the access site. In addition, the ER-REBOA catheter doesn’t require multiple wire exchanges. Importantly, it also has a soft, atraumatic tip and provides for simultaneous arterial pressure monitoring.
Pryor Medical has scheduled first delivery of its catheters for January 1, 2016.
About
REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta)
Based on lessons
learned during war, there is growing clinical use of a minimally invasive
vascular technique called REBOA which uses balloon catheters to temporary
occlude large vessels. However, existing balloon occlusion catheters were not
designed primarily for use by trauma, critical care and emergency medicine
doctors. The team at
Pryor Medical has an unlimited, exclusive, worldwide license to underlying IP (intellectual
property) created by two of the world’s leading REBOA practitioners. The
company has improved and expanded upon its IP to create the ER-REBOATM
Catheter, a 7 Fr compatible balloon catheter for temporary occlusion of large
vessels and arterial pressure monitoring.
Source: Pryor Medical Devices - The REBOA Company
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