Procyrion has announced the treatment of the first patients in a 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 trial in Australia and recently expanded to the USA after receiving Investigational Device Exemption (IDE) approval in April from the US Food and Drug Administration (FDA).
“We are thrilled to be the first centre in the US to treat CRS patients with the Aortix device. The procedure was performed safely and easily due to the pump’s position in the aorta versus the heart, which allowed for rapid deployment of the catheter-based pump and significantly reduced the risk of stroke and damage to the heart,” stated Jennifer Cowger, medical director of the Mechanical Circulatory Support Program and Co-Director of the Cardiac Intensive Care Unit at Henry Ford Hospital in Detroit, USA. “After completing therapy, the patient showed significant improvement in the key haemodynamic parameters, shed over 10L of excess fluid, and greatly improved creatinine levels, a measure of kidney function.”
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 seven 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.
“I am extremely pleased to be the first user of the Aortix system,” commented David Kaye, director of cardiology at The Alfred in Melbourne, Australia. “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.”
The CRS pilot study is a prospective and multicentre trial that will enrol up to 45 patients in Australia and the USA. The study received a Category B designation and subsequent approval from Centers for Medicare & Medicaid Services (CMS), which will allow coverage of the Aortix device and routine care services during the trial.