Procyrion’s Aortix Percutaneous Mechanical Circulatory Support Device Evaluated in Pilot CRS Study

May 25, 2021—Procyrion, Inc. announced the successful treatment of the first patients in the company’s pilot trial to evaluate the performance of its Aortix percutaneous mechanical circulatory support device in patients with cardiorenal syndrome (CRS). CRS is a large subset of acute decompensated heart failure (ADHF) that affects up to 40% of all United States ADHF patients and is growing at a double-digit rate. The company began its pilot trial in Australia and recently expanded to the United States after receiving investigational device exemption approval in April from the FDA.

According to Procyrion, the CRS pilot study is a prospective multicenter trial that will enroll up to 45 patients in Australia and the United States. The study received a Category B designation and subsequent approval from the Centers for Medicare & Medicaid Services, which will allow coverage of the Aortix device and routine care services during the trial. Aortix is an investigational device and is not approved for sale in any market.

Procyrion’s 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 company noted that the Aortix device 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 integrates into practices as the pump can be deployed in less than 10 minutes, and device operation does not require large or expensive capital equipment.

“We are thrilled to be the first center in the United States to treat CRS patients with the Aortix device,” commented Jennifer Cowger, MD, in the company’s press release. “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.”

Dr. Cowger continued, “After completing therapy, the patient showed significant improvement in the key hemodynamic parameters, shed over 10 liters of excess fluid, and greatly improved creatinine levels, a measure of kidney function.” Dr. Cowger is Medical Director of the Mechanical Circulatory Support Program and Co-Director of the Cardiac Intensive Care Unit at Henry Ford Hospital in Detroit, Michigan.

Professor David Kaye, MBBS, PhD, Director of Cardiology at The Alfred in Melbourne, Australia, commented, “I am extremely pleased to be the first user of the Aortix system. 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 readmission rates. We are excited about Aortix’s potential to disrupt the harmful CRS cycle through its simultaneous cardiac unloading and enhancement of renal perfusion.”