DRAIN-HF Pivotal IDE Trial of Procyrion’s Aortix pMCS Device Begins Enrollment

November 30, 2023—Procyrion, Inc. announced the enrollment of the first patients in the company’s DRAIN-HF pivotal trial of the Aortix percutaneous mechanical circulatory support (pMCS) technology in patients with acute decompensated heart failure (ADHF) who are unresponsive to standard medical therapy.

Procyrion’s Aortix is a catheter-deployed pump placed in the descending thoracic aorta and designed to directly unload the heart and improve cardiac performance while increasing perfusion to the kidneys. The pump technology is designed to harness fluid entrainment to pump blood, addressing multiple conditions with significant unmet needs.

Conducted under an FDA investigational device exemption, DRAIN-HF is evaluating the safety and effectiveness of the Aortix pump compared to standard of care medical therapy including high-dose intravenous 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 at 45 centers in the United States. It designed to include a randomized arm as well as a registry arm. The registry arm is 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 implantation because of excessive fluid retention and poor kidney function. In September 2023, the company announced approval from the Centers for Medicare and Medicaid for Medicare coverage during the DRAIN-HF pivotal trial.

The first patient in the randomized portion of the trial was enrolled by Bassem Chehab, MD, at the Ascension Via Christi Hospital in Manhattan, Kansas.

“I am thrilled to enroll the first patient in this important trial,” commented Dr. Chehab in Procyrion’s press release. “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.”

The first patient in the registry was enrolled by Gillian Grafton, DO, at Henry Ford Hospital in Detroit, Michigan.

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

Finally, the company reported that the CRS Pilot Study of the safety and performance of the Aortix device in ADHF and cardiorenal syndrome 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.

The CRS Pilot Study was published by Jennifer A. Cowger, MD, et al in JACC: Heart Failure (2023;11:1565-1575).

Aortix is limited by Federal law to investigational use only is and is not approved for sale in any geography, advised the Procyrion.