FDA granted breakthrough device designation to Procyrion's Aortix, a circulatory support device for use in chronic heart failure patients, the company announced this week.
Procyrion's Aortix aims to offer physicians a minimally invasive, lower-risk alternative to left ventricular assist devices (LVADs) when treating patients with acute decompensated heart failure (ADHF) and worsening renal function.
The designation positions Procyrion to engage more frequently with FDA as it seeks to build on a small clinical study of Aortix and get the device to market.
Around two-thirds of people admitted to hospital with ADHF have moderate or worse renal dysfunction. That creates an additional challenge for physicians, who need to both decrease the burden on the patient's heart and increase renal perfusion. LVADs, such as Abbott's HeartMate 3 and Medtronic's HeartWare, decrease the load on the heart but are costly and deliver therapy via invasive procedures.
Aortix is delivered in a minimally invasive procedure via a femoral catheter to the descending aorta. Once in place, the device is designed to decongest the patient through a pump action that reduces the pressure the heart has to pump against while increasing pressure and flow in the kidneys.
Procyrion is yet to generate comprehensive clinical data but the results it does have were sufficient to secure a breakthrough designation. In a six-patient first-in-human study, delivery of the device took four to nine minutes. The device supported the patients for 70 minutes, on average, during which time patients experienced a ten-fold increase in urine output.
No patients experienced adverse events or hemodynamic compromise nor were there any cases of clinically significant hemolysis. The small study was also free of vascular access complications, leading the authors to conclude the device was successfully deployed and retrieved.
More rigorous tests await Aortix but Procyrion will now have extra support from FDA. The FDA breakthrough designation makes Procyrion eligible for more frequent interactions with the agency during Aortix's development. Procyrion may also benefit from prioritized review once it gets to the filing stage, and potentially easier access to Medicare beneficiaries if a proposed new rule from CMS providing coverage and increased payments for breakthrough devices is implemented and the device gets a nod from FDA. Medicare's current payment system provides limited access to new technologies.
Procyrion raised $30 million earlier this month to support further development of Aortix. The money will enable Procyrion to fund work needed to support an application with FDA to run a pivotal trial.