Our Product

When a radial balloon burst occurs, the torn balloon can be safely navigated down to the aortic bifurcation but cannot enter the femoral vein. Thus, we have developed a new product and procedure to assist with the safe removal of the torn balloon from the patient’s body. Our product, the Sapien 6 Retrieval Catheter System, is a customized sheath, catheter, and dilator that is designed to assist the torn balloon back into the delivery catheter. The image on the right shows the 4 components of the retrieval system: the guide wire, the sheath, the dilator, and catheter (from the left to right). The guide wire is the train tracks of the system; the sheath is how the physician gains access to the vasculature; the dilator provides a conical tip so the catheter doesn’t damage the vasculature; the Sapien 6 Retrieval Catheter will complete the balloon encapsulation. Our proposed procedure involves the device entering the left axillary artery, traveling down the descending aorta, and completing the balloon retrieval at the aortic bifurcation, allowing for the safe removal from the patient's femoral vein. The device was carefully designed to be flexible enough to travel around the aortic arch but sturdy enough for the surgeon to capture the torn balloon at the retrieval point by applying a pushing force on the catheter. This was achieved using multiple PEBAX durometers (stiffness levels) along the length of the device.