Pryor Medical Devices Receives FDA 510(k) Clearance for Distribution of Its ER-REBOA Catheter
New catheter provides a minimally invasive solution for temporary occlusion of large vessels and arterial pressure monitoring
SAN ANTONIO, Oct. 26, 2015 /PRNewswire/ -- Pryor Medical Devices (The REBOA CompanyTM), today announced it has received FDA 510(k) clearance for the sale and distribution of its ER-REBOATM 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.
"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.
About Pryor Medical Devices – The REBOA Company™
Pryor Medical Devices, Inc. (The REBOA CompanyTM) is an innovative medical device company that designs, develops and commercializes minimally invasive solutions for vascular trauma. The company's flagship product is the ER-REBOATM Catheter, a 7 Fr compatible balloon catheter for temporary occlusion of large vessels and pressure monitoring. In addition, the company is developing multiple next generation REBOA catheters and other minimally invasive solutions of interest. More information can be found at www.pryormedical.com or by calling (210) 340-0116
SOURCE Pryor Medical Devices
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