Aortix Pump Therapy Leads to Rapid Decongestion and Improved Kidney Function in Hospitalized Patients with Heart Failure and Worsening Renal Function

• Late-breaking data presented at THT shows substantial fluid loss and improvements in kidney and cardiac function at 30 days after Aortix therapy;
   
• Cardiorenal syndrome (CRS) is a complex condition that impacts up to 40% of patients with acute decompensated heart failure and is growing at a double-digit rate

HOUSTON -- Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced that use of its Aortix™ percutaneous mechanical circulatory support (pMCS) device led to rapid decongestion in a pilot study of patients admitted to the hospital with acute decompensated heart failure (ADHF) and worsening renal function, which is known as cardiorenal syndrome (CRS). These patients, who were unresponsive to available medical therapy, demonstrated significant improvements in kidney function, cardiac function, and patient-reported assessment of shortness of breath at 30 days after treatment with the Aortix pump. The results from the CRS pilot study were presented today during the late-breaking clinical science session at the Technology and Heart Failure Therapeutics (THT) conference in Boston.

Late-breaking data presented at THT shows substantial fluid loss and improvements in kidney and cardiac function at 30 days after Aortix pump therapy in patients admitted to the hospital with acute decompensated heart failure (ADHF) and worsening renal function, which is known as cardiorenal syndrome (CRS).

"Patients admitted to the hospital with CRS are the most difficult to treat. They often have persistent congestion even after aggressive intravenous diuretic therapy, leading to very poor outcomes with high rates of mortality and rehospitalization," stated Jennifer A. Cowger, MD, MS, FACC, Section Head of Heart Transplantation and Mechanical Circulatory Support, Henry Ford Hospital in Detroit, MI. "After being unresponsive to available medical therapy for more than a week, patients who were treated with the Aortix pump showed a significant increase in urine output resulting in a large loss of excess fluid and improvements in kidney function present at 30 days, indicating the potential of the Aortix therapy to disrupt the harmful cycle of CRS."

CRS is a complex disease with cardiac, renal, and neurohormonal components, impacting up to 40% of all patients admitted with ADHF in the US and growing at a double-digit rate.1 In CRS, underlying heart failure leads to reduced blood flow to the kidneys, which causes the kidneys to become less effective at removing excess fluid from the body. This can lead to symptoms such as swelling in the lower limbs and abdomen, congestion, shortness of breath, and fatigue, making it difficult for patients to engage in everyday activities. Effective treatment options for CRS with persistent congestion are lacking, as evidenced by up to a 25% heart failure rehospitalization or mortality rate at 30 days2,3 for those patients who remained clinically congested after 96 hours of optimal medical therapy and were discharged from the hospital.4

The CRS pilot study treated 18 patients across 10 centers in the US and in Australia. Statistically significant observations include:

• Rapid decongestion as patients shed on average 10.7 liters of excess fluid
• Filling pressures (central venous pressure and pulmonary capillary wedge pressure) decreased by over 33%
• Kidney function improved by a median of 29% at 30 days, as measured by eGFR
• Cardiac function improved by a median of 34% at 30 days, as measured by an important biomarker of heart failure (NT-proBNP)
• Shortness of breath symptoms were reduced by 46% at 30 days

The Aortix pump was placed in the descending thoracic aorta via a percutaneous catheter procedure and treated patients for a mean of 4.6 days to simultaneously unload and rest the heart and increase perfusion of the kidneys. The innovative design uses intra-aortic placement and harnesses fluid entrainment to pump blood without the need of a valve and provides physiologically natural delivery of therapy. Use of the system easily integrates into practices as the Aortix system can be implanted in approximately 45 minutes and retrieved in about 15 minutes at the completion of therapy. No fluid purges or expensive consoles are required to operate the device.

"The consistent results from the pilot study indicate that Aortix therapy has the potential to be a major therapeutic advancement for CRS patients who have exhausted other treatment options," stated Eric. S. Fain, MD, President and Chief Executive Officer, Procyrion. "After years of development, it is very exciting to see how well the Aortix platform performs clinically and we look forward to further demonstrating the effectiveness of the system in our upcoming DRAIN-HF pivotal trial, which the company plans to initiate later this year."

About Procyrion

Procyrion, Inc. is a privately held medical device company dedicated to providing effective treatment options for patients with cardiac and renal impairment. The company is developing the Aortix™ percutaneous mechanical circulatory support device, a catheter-deployed pump technology that uniquely harnesses fluid entrainment to pump blood to address multiple conditions with significant unmet needs. The platform technology is currently being evaluated for in-hospital therapy of cardiorenal syndrome (CRS) patients and prevention of acute kidney injury (AKI) associated with cardiac surgery. Aortix is limited by Federal law to investigational use only and is not approved for sale in any geography. Please visit www.procyrion.com for more information.

References:

1. Based on ICD-10 codes for acute heart failure in National Inpatient Survey of data through 2017
2. Bart et al., N Engl J Med 2012; DOI: 10.1056/NEJMoa1210357
3. Wattad et al., Am Journal of Cardiol 2015; DOI: 10.1016/j.amjcard.2015.01.019
4. Procyrion CRS Registry Data. Presented at HFSA 2020