Procyrion Announces First Patient Enrollments in the DRAIN-HF Pivotal IDE Trial for Aortix Percutaneous Mechanical Circulatory Support Technology

Technology to be evaluated in acute decompensated heart failure patients, where current treatment options remain ineffective and lacking

HOUSTON - Procyrion, Inc., a medical device company dedicated to improving outcomes for patients with cardiac and renal impairment, announced the enrollment of the first patients in the company's IDE pivotal trial. The DRAIN-HF (Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure) study will evaluate the Aortix™ percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heart failure (ADHF) who are unresponsive to standard medical therapy. The first patient in the randomized portion of the trial was enrolled by Bassem Chehab, MD, FACC, at the Ascension Via Christi Hospital.

The DRAIN-HF study will evaluate the Aortix™ percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heart failure (ADHF) who are unresponsive to standard medical therapy.

"I am thrilled to enroll the first patient in this important trial. Today, there are no effective treatment options for patients with ADHF who remain congested despite being treated with high dose intravenous diuretic therapy. These patients have very poor outcomes in terms of death and rehospitalization and therefore new therapy options are critically needed," stated Dr. Chehab.

The study also includes a registry for advanced heart failure patients who are end stage and not considered to be surgical candidates for a heart transplant or left ventricular assist device (LVAD) implant due to excessive fluid retention and poor kidney function. The first patient in the registry was enrolled at Henry Ford Hospital in Detroit, Michigan by Gillian Grafton, DO.

"The Aortix pump demonstrated promising results to help off-load fluid and improve kidney function. I am excited to be able to include the advanced heart failure patients in the trial," commented Dr. Grafton.

The DRAIN-HF pivotal trial (NCT05677100) is evaluating the safety and effectiveness of the Aortix pump compared to standard of care medical therapy including high dose IV diuretics in patients hospitalized with ADHF who have persistent congestion and demonstrated diuretic resistance despite optimal medical management. The study will enroll up to 268 patients across 45 centers in the US and will include a randomized arm as well as a registry arm that will enroll patients who are targeted for a heart transplant or LVAD but are too sick to be considered for surgery. The company recently announced it has received CMS approval for Medicare coverage during the DRAIN-HF pivotal trial.

Approximately 25-30% of ADHF patients admitted to the hospital have cardiorenal syndrome (CRS) characterized by resistance to standard of care intravenous diuretic therapy¹, where underlying heart failure leads to reduced blood flow to the kidneys, causing the kidneys to become less effective at removing excess fluid from the body. Effective treatment options for CRS are lacking, as evidenced by up to a 25% rate for heart failure rehospitalization or mortality at 30 days^2,3 for those patients who remained clinically congested after 96 hours of standard of care medical therapy and were discharged from the hospital.¹

"The initiation of the DRAIN-HF pivotal study represents a major milestone in the company's commitment to make Aortix available for these acutely decompensated heart failure patients who have failed aggressive standard of care medical therapies," said Eric S. Fain, MD, President and Chief Executive Officer, Procyrion. "We look forward to working with our investigators and research teams to advance the scientific evidence around this groundbreaking technology."

Aortix is a catheter-deployed pump that is placed in the descending thoracic aorta and designed to directly unload the heart and improve cardiac performance while increasing perfusion to the kidneys. In the CRS Pilot Study, which was published in the Journal of the American College of Cardiology: Heart Failure, patients demonstrated rapid decongestion with substantial removal of excess fluid and improved hemodynamics, as well as significant improvements in kidney function, cardiac function, and patient-reported assessment of shortness of breath sustained out to 30 days after treatment with the Aortix pump.

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. 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. Cooper et al. Clin Cardiol. 2023 Jul 18. DOI: 10.1002/clc.24080
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

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