Onset Medical has received FDA 510(k) marketing clearance for new access applications of the SoloPath TransFemoral Endovascular Access Catheter. With the FDA marketing clearance, Onset believes that SoloPath offers a complete line of products for access to the larger vascular anatomy with designs that provide a superior method of accessing the larger vessels.
Onset’s SoloPath Endovascular Access Catheters are designed to provide access to diseased arteries at a relatively small catheter size and then be expanded to provide a conduit for the delivery of larger diameter devices.
Onset Medical said that the SoloPath may help a number of patients who can be effectively treated percutaneously with femoral/iliac artery stent grafts, aortic stent grafts and new technology such as the percutaneous aortic heart valves that are marketed in Europe and under clinical study in the US.
Joseph Bishop, chief executive officer of Onset Medical, said: “SoloPath is an enabling platform in that it can establish a repeatable and predictable method of access where other devices cannot, thus providing the potential for a larger patient population to be successfully treated.
“While many companies provide access products for the delivery of smaller therapeutic devices, we believe that Onset is in a unique position to provide access for the delivery of larger therapeutic devices such as AAA stent grafts, percutaneous delivered aortic heart valves, percutaneous mitral valve repair devices and cardiac assist products.”
Onset Medical said that a major clinical market for the SoloPath Catheter is in the delivery of stent grafts for the treatment of aortic aneurysms (AAA stent grafts). The stent grafts require large catheter delivery systems. They are implanted minimally invasively as a substitute for conventional open surgical procedures to treat ruptured aneurysms.