Procyrion, a medical device company developing catheter-deployed pump technology, has successfully treated the first patients in the company’s pilot trial to evaluate the performance of its novel Aortix™ percutaneous mechanical circulatory support (pMCS) device in patients with cardiorenal syndrome (CRS). The company began its pilot trial in Australia and recently expanded to the U.S. after receiving Investigational Device Exemption (IDE) approval in April from the U.S. FDA.
The Aortix system
The Aortix system is a platform technology that will initially target the treatment of CRS, a multifactorial disease with cardiac, renal, and neurohormonal components contributing to its cause. The device is placed in the descending thoracic aorta via a percutaneous catheter procedure for up to 7 days to simultaneously unload and rest the heart and increase perfusion of kidneys. The innovative design uses intra-aortic placement and harnesses fluid entrainment to pump blood without the need of a valve and allows for physiologically natural delivery of therapy. Use of the system easily integrates into practices as the pump can be deployed in less than 10 minutes and device operation does not require expensive equipment.
The first to use the Aortix system, Prof. David Kaye, Director of Cardiology at The Alfred in Melbourne, Australia, commented: “With CRS, low blood flow to the kidneys, as a result of underlying heart failure, causes activation of the neurohormonal system and signals the body to retain fluid, further straining the heart and exacerbating heart failure. This negative cycle causes a downward spiral in patients, leading to increased mortality and high re-admission rates. We are excited about Aortix’s potential to disrupt the harmful CRS cycle through its simultaneous cardiac unloading and enhancement of renal perfusion.”
CRS is a large subset of acute decompensated heart failure (ADHF) that affects up to 40% of all U.S. ADHF patients and is growing at a double-digit rate. CRS is a complex disease that currently lacks effective treatment options, as evidenced by a 20% and 33% re-hospitalization or mortality rate at 30 days and 90 days post CRS hospitalization, respectively, for those patients who remained clinically congested after 96 hours of optimal medical therapy and discharged from the hospital.
“Despite the improvement in outpatient treatment of chronic heart failure, there have been few advances in effective medical or device therapies for hospitalized ADHF patients and in particular CRS patients. These patients are especially difficult to manage and decongest and have very poor outcomes. We believe Aortix has the potential to fill this large unmet need,” said Eric. S. Fain, MD, president and CEO of Procyrion.
The CRS pilot study is a prospective and multi-centre trial that will enrol up to 45 patients in Australia and the U.S. The study received a Category B designation and subsequent approval from Centers for Medicare & Medicaid Services (CMS), which will allow coverage of the Aortix