Procyrion Australia Pty Ltd
Procyrion is developing the Aortix™ percutaneous mechanical circulatory support device aimed at treating heart failure patients who are too sick for medication alone. The device is designed to reduce cardiac workload, increase renal perfusion, and can be deployed percutaneously in less than 10 minutes. It aims to address the large and growing unmet clinical need of cardiorenal syndrome, which affects over 6 million adults in the U.S. and results in significant hospitalizations, deaths, and economic costs. Procyrion's technology has received recognition and awards, and is currently under clinical evaluation for indications including acute decompensated heart failure and renal support.
Industries
Nr. of Employees
small (1-50)
Procyrion Australia Pty Ltd
Products
Investigational percutaneous intra-aortic circulatory support pump
An investigational catheter-delivered axial-flow pump designed to be implanted in the descending aorta to reduce cardiac afterload and increase downstream aortic flow with the goal of improving cardiac efficiency and renal perfusion. Intended clinical uses under evaluation include acute decompensated heart failure with diuretic resistance and perioperative renal protection.
Investigational percutaneous intra-aortic circulatory support pump
An investigational catheter-delivered axial-flow pump designed to be implanted in the descending aorta to reduce cardiac afterload and increase downstream aortic flow with the goal of improving cardiac efficiency and renal perfusion. Intended clinical uses under evaluation include acute decompensated heart failure with diuretic resistance and perioperative renal protection.
Services
Clinical development and trial execution for investigational circulatory assist devices
Design and conduct of pilot studies and pivotal IDE trials for investigational transcatheter circulatory support devices, including multi-site enrollment and investigation of renal and hemodynamic endpoints.
Device product development and engineering
Engineering, preclinical testing, and iterative optimization of a catheter-delivered circulatory pump using CFD, bench testing, and large-animal studies to support human evaluation.
Regulatory and quality systems implementation
Establishment and maintenance of QMS aligned with ISO 13485 and relevant US regulations, and management of regulatory interactions and coding/reimbursement activities.
Clinical development and trial execution for investigational circulatory assist devices
Design and conduct of pilot studies and pivotal IDE trials for investigational transcatheter circulatory support devices, including multi-site enrollment and investigation of renal and hemodynamic endpoints.
Device product development and engineering
Engineering, preclinical testing, and iterative optimization of a catheter-delivered circulatory pump using CFD, bench testing, and large-animal studies to support human evaluation.
Regulatory and quality systems implementation
Establishment and maintenance of QMS aligned with ISO 13485 and relevant US regulations, and management of regulatory interactions and coding/reimbursement activities.
Expertise Areas
- Clinical trial management for investigational medical devices
- Percutaneous mechanical circulatory support (pMCS) device development
- Transcatheter implantation and procedural workflows
- Cardiorenal syndrome and acute decompensated heart failure therapeutics
Key Technologies
- Percutaneous catheter-delivered axial-flow pumps
- Intra-aortic continuous-flow pump mechanics
- Catheter-based trans-femoral delivery systems
- Micro-motor driven continuous-flow mechanisms