Procyrion’s Aortix Pump Evaluated in FIH Study to Prevent AKI in Cardiac Surgery Patients

February 22, 2023—Procyrion, Inc. announced the successful treatment of the first patients in the A PRIORI pilot trial evaluating the performance of the company’s Aortix percutaneous mechanical circulatory support (pMCS) device in preventing acute kidney injury (AKI) during cardiac surgery.

The A PRIORI study will enroll up to 50 patients across four clinical sites in Australia: Royal Adelaide Hospital in Adelaide, South Australia; Monash Health in Melbourne, Victoria; Princess Alexandra Hospital in Brisbane, Queensland; and Macquarie University in Sydney, New South Wales.

Professor Stephen Worthley, MBBS, PhD, with Macquarie University Hospital, commented in the company’s press release, “We are thrilled to be the first center in the world to provide Aortix pump therapy during a cardiac surgery with the goal of reducing the risk of AKI.” Prof. Worthley further explained, “Patient history can help identify those with known risk factors for developing AKI, and the Aortix pump has the potential to address major risk factors both during and after surgery by improving renal artery flow. The catheter-based pump was easy to deploy, operated in a location that did not interfere with the surgery, and greatly improved perfusion to the kidneys.”

According to the company, the Aortix pump is designed to harness fluid entrainment to directly increase renal artery flow and pressure and allows for physiologically natural delivery of therapy.

The Aortix pMCS device is placed in the descending thoracic aorta via a percutaneous catheter procedure at the beginning of the scheduled surgical procedure to directly increase perfusion to the kidneys while reducing cardiac energy requirements. The pump can be deployed in < 15 minutes, and the intra-aortic placement essentially eliminates the risk of device-related thrombotic stroke or damage to the heart or valves.

The Aortix pump is intended to be left up to 48 hours postsurgery to maintain increased renal perfusion to provide additional protection against postoperative risk factors for AKI and decrease the workload of the recovering heart, stated the company.

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

Additionally, the company advised in the press release that the Aortix CRS pilot study of the device for cardiorenal syndrome was recently completed. Jennifer Cowger, MD, with Henry Ford Health Heart & Vascular Institute in Detroit, Michigan will present the study on March 21, 2023, in the late-breaking clinical science session at the Technology and Heart Failure Therapeutics conference in Boston, Massachusetts.