The Arterial Restrictive Clamp was created as part of a capstone project in 2018 and will likely be FDA approved in early 2024.
The Arterial Restrictive Clamp was designed in 2018 by Cedarville University students Austin Ballentine and Caleb Williams following getting the idea from fellow student Lauren Edmonson, an EMT who noted there was a serious gap in the treatment of arterial wounds. Following creating a company to manufacture and test the device, it is now pending FDA approval in 2024.
According to an article on Cedarville University’s website, Dr. Tim Norman, professor of biomedical and mechanical engineering, is the one who Edmonson came to about her desire to find a way to save people with arterial injuries. Dr. Norman helped Edmonson connect with engineering students, including Ballentine and Williams, who worked together and helped bring Edmonson’s idea to fruition as part of their capstone project.
Dr. Norman described their invention: “This device that the students worked on is relatively new, but it addresses life-threatening injuries where there aren’t many solutions on the market today. This device has the potential to meet a life-and-death situation where options are limited and the timeline is critical.” He went on to explain carotid artery injuries, which are most common in combat situations, though do come up elsewhere from time to time, such as sports injuries: “The only treatment for this wound is to hold and apply pressure. In the case of this kind of wound suffered in the military, where we see these injuries occur, a medic is taken out of action by needing to stay with the injured and putting pressure on the wound. With our proposed device, the clamp can put pressure on the carotid artery and stop the bleeding. When this happens, the medic can care for other people who are injured or transport the patient.”
Dr. Norman, Ballentine, and Williams teamed up with surgeon Dr. Jeff Williams. The team formed the company Arc Trauma, LLC, and set to work to create the device and then test it. Testing for this device was done on a cadaveric perfusion model to simulate realistic occasions for which the device would be necessary.
Explaining what the device does, Dr. Norman said, “The device was designed to be a kind of neck tourniquet. The difference is that in all other tourniquets apply pressure circumferentially; however, we needed to ensure that the patient could still breath easily, medical providers could still access the airway, and the brain still received blood flow from the uninjured carotid artery. We came up with this device to fit around the neck and quickly apply pressure to the specific point of injury while allowing blood flow through the rest of the neck and keeping the air pathways open.”
Since beginning the testing phase, the team has made modifications to the device and have received feedback as well as interest from the local medical community, proving that the device would be a welcome addition to the suite of life saving devices at the disposal of medical staff.
After the next round of testing, the next step will be to submit to the FDA for final approval.
For more information about Cedarville University, visit the school’s website.