 |
| ER-REBOA balloon--Courtesy of Pryor Medical Devices |
Pryor Medical Devices won an FDA nod for its balloon catheter last month to temporarily occlude large vessels and monitor blood pressure in a trauma emergency. But the regulatory clearance is specifically for its use in conjunction with fluoroscopy, which is often impractical in an emergency care setting.
Now, the U.S. military has stepped in with a $14.3 million contract to conduct a clinical trial to support an FDA clearance of its ER-REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) balloon without the use of fluoroscopy. That would enable its use on the battlefield to more effectively treat noncompressible torso hemorrhages, which are the top cause of potentially survivable death in combat.
"We are honored to be selected for this important research effort," said Pryor Medical Devices CEO David Spencer in a statement. "The military is working hard to make sure in future conflicts, no wounded warrior ever bleeds to death from potentially survivable wounds."
The use of a balloon catheter to occlude large veins isn't new, but the ER-REBOA is the first specifically cleared by FDA for that purpose. It's slated to launch at the start of 2016. Otherwise, a surgeon would typically work to control this type of trauma bleeding via aortic clamping.
The contract is specifically with the Naval Health Research Center and the U.S. Army.
 |
| ER-REBOA balloon--Courtesy of Pryor Medical Devices |
The ER-REBOA is was developed by trauma surgeons to offer an easy-to-use, over-the-wire balloon catheter to encourage its use even in emergency situations without personnel specifically trained in endovascular techniques.
The device is tiny, only a bit larger than 2 mm, and it doesn't require multiple wire exchanges for placement. It has a soft, atraumatic tip and also offers simultaneous arterial pressure monitoring. It enables emergency personnel to quickly and effectively staunch this kind of hemorrhage to enable surgeons to address the cause of the bleeding.
Just before the FDA nod, in September the San Antonio, TX area based startup received a $5 million Series B infusion from investors including BriarPatch Partners, an affiliate of the oil and gas businesses that fall under the Hunt Family of Companies.
"The REBOA technique shows great promise in preventing potentially survivable death in both military and civilian settings," added Pryor's Spencer. "This contract will support research efforts to advance the science of the REBOA technique in general, while also funding a clinical trial of great promise for possible fluoroscopy free use."
- here is the announcement