Aortic dissection flap division by novel electrosurgical catheter facilitates aortic endograft landing zones

PROJECT SUMMARY Acute Aortic dissection (AAD) is a catastrophic, life-threatening disorder with 2,000 new cases per year and an in-hospital mortality rate of 27.4% in the US alone. AAD results from the separation of the layers of the aortic wall, with blood traveling in the true lumen but also into a false lumen created by the dissection flap or septum. It presents as abrupt tearing chest and/or back pain. Patients who survive into the subacute and chronic phases of their dissection may present with aneurysmal changes in the aorta, resulting in additional risks of aneurysm rupture. The current standard of care is open surgery (OS), which carries a series of risks, including spinal cord ischemia, renal failure, bowel ischemia, respiratory complications, major bleeding, and inability of patients to return to a functional state. Endovascular stent grafting with Thoracic Endovascular Aortic Repair (TEVAR) or Endovascular Aneurysm Repair (EVAR) are more favorable alternative treatments than OS but also carry unique associated risks, such as endoleaks, graft compression or persistent filling of the false lumen. In this STTR Phase I project, CutCath LLC aims to examine the safety and efficacy of a novel and minimally invasive device called the CutCath Dissection Septum Cutting Catheter (DSCC), to facilitate effective landing zones for TEVAR or EVAR, increasing the percentage of patients suitable for TEVAR/EVAR and improving the technical success of the procedure. The CutCath DSCC has been designated a breakthrough device by the FDA. It has completed verification and validation bench testing and is preparing for a first in human Early Feasibility Study (EFS). Through the use of radiofrequency and a novel catheter design, the CutCath DSCC allows complete fenestration of the dissection septum in targeted region of the aorta. This will enable full apposition of the endovascular graft to the aortic wall, more effectively excluding the aneurysmal portion and decreasing risk of false lumen pressurization, aneurysm enlargement and rupture that can occur following TEVAR/EVAR if the septum is left intact. In Phase I Aim 1, Cut Cath aims to determine the safety and efficacy of the CutCath DSCC in dividing subacute and chronic aortic dissection flaps. In Aim 2, CutCath plans to assess the short-term safety and efficiency of aortic dissection septotomy by clinical and imaging evaluations within 30 days post-procedure. If successful with Phase I, CutCath will determine the mid-and long-term safety and efficacy of the CutCath DSCC in Phase II. The success of this project will aid in achieving FDA approval. More importantly, the CutCath DSCC will provide a safer, more effective, and more efficient treatment of aortic dissection with aneurysm than current treatment methods, such as OS and TEVAR or EVAR alone.