Procyrion Announces Successful First-in-Human Cases in Cardiorenal Syndrome (CRS) Patients with Aortix™ Percutaneous Mechanical Circulatory Support Device
Pilot CRS Study to Evaluate Performance of Novel Aortix device in Australia and the U.S.
HOUSTON -- Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced today successful treatment of 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. Food and Drug Administration (FDA).
"We are thrilled to be the first center in the U.S. 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 Dr. 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, MI. "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."
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 large or expensive capital equipment.
"I am extremely pleased to be the first user of the Aortix system," commented Prof. 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."
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," stated Eric. S. Fain, MD, president and chief executive officer of Procyrion.
The CRS pilot study is a prospective and multi-center trial that will enroll 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 device and routine care services during the trial.
Procyrion Inc. is a privately held medical device company that is dedicated to providing effective treatment options for cardiac and renal impaired patients. The company is developing a catheter-deployed pump technology to address multiple conditions with significant unmet needs. The first application of this platform technology is for in-hospital therapy of CRS patients. Aortix is not approved for sale in any geography. Caution: Investigational device. Limited by Federal law to investigational use. Please visit www.procyrion.com for more information.
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