Procyrion starts enrolling patients in DRAIN-HF Pivotal IDE Trial for Aortix™ Circulatory Support
Friday, December 01, 2023
Procyrion, has embarked on the enrollment of initial participants in its pivotal trial, DRAIN-HF, conducted under the Investigational Device Exemption (IDE). This trial aims to appraise the efficacy and safety of the Aortix™ percutaneous mechanical circulatory support (pMCS) technology tailored for patients grappling with acute decompensated heart failure (ADHF) and unresponsive to conventional medical interventions.
The primary focus is on evaluating the Aortix pump's performance compared to standard medical therapy, particularly high-dose intravenous (IV) diuretics, in ADHF patients enduring persistent congestion and diuretic resistance despite optimal medical management. With a targeted enrollment of up to 268 patients across 45 centers in the United States, the study encompasses a randomized arm and a registry arm, catering to advanced heart failure patients who are deemed unfit for heart transplant or left ventricular assist device (LVAD) surgery due to excessive fluid retention and compromised kidney function.
Aortix, a catheter-deployed pump positioned in the descending thoracic aorta, endeavors to directly alleviate cardiac strain and enhance performance while simultaneously improving kidney perfusion. Procyrion, Inc.'s initiation of the DRAIN-HF pivotal trial underscores its commitment to addressing the unmet needs of ADHF patients resistant to standard care through innovative medical technologies.