We give cardiologists a tool that lets the heart rest and heal without surgery
A tool for the Cardiologist
The Procyrion device consists of a small, continuous flow pump mounted within a self-expanding anchoring system. The device is advanced through a catheter in the femoral artery to the descending thoracic aorta. The self-expanding anchors deploy to fix the pump to the aortic wall. Following deployment, the catheter is fully removed, leaving only the anchored pump and a small diameter, flexible electrical power wire which may be tunneled to a desired transdermal exit site or to a Transcutaneous Energy Transfer (TET) system for subcutaneous implantation without an indwelling power lead. Compared to traditional LVADs, Procyrion replaces a major surgery and a lengthy hospital stay with a minimally invasive outpatient procedure.
An opportunity to rest and heal the heart
The focus of circulatory support for nearly 50 years has been to replace the function of the ailing heart. This has resulted in large, cumbersome surgical devices that provide full circulatory support. Recent clinical evidence from partial circulatory support devices (B.P. Meyns et al. / European Journal of Cardio-thoracic Surgery 39 2011 693—698) and cardiac resynchronization therapy devices (Sutton et al. Circulation. 2003;107:1985-1990) suggests that the class III heart failure patient can benefit from partial circulatory support. The Procyrion device seeks to reduce afterload, reduce workload of the heart, and increase end-organ perfusion. Together, these factors provide the potential to rest and heal the heart thereby improving patient quality of life and reducing the cost of heart failure.
Focus on reducing risks
The Procyrion device reduces risk in three main areas:
Minimal Procedural Risk
Procyrion is developing a cardiologist friendly tool for the catheter lab. Our minimally invasive cath-lab tool and our outpatient procedure dramatically reduce procedural risks when compared to full support circulatory assist devices that require invasive surgery and 40 days in the hospital, on average. Unlike other circulatory assist devices, the Procyrion device is deployed downstream of the heart, eliminating the risk of damage to the heart or valves and simplifying the deployment.
Minimal Thrombosis Risk
The single biggest risk for patients with circulatory support devices is a thrombotic stroke. Up to 40% of patients with surgical ventricular assist devices end up with a stroke. Many of these patients are awaiting a heart transplant and, because of the stroke, are no longer eligible. The Procyrion device is deployed downstream of the carotid arteries that supply the brain and therefore has minimal thrombotic stroke risk.
Downstream thrombotic events are also unlikely since the Procyrion device functions in series with the heart, without distrupting native pulsatile flow. This minimizes stasis, since our device is continuously flushed with high volumes of native blood flow.
Minimal Failure Risk
Traditional support devices replace the function of the heart, as opposed to supporting native heart function. In those cases, a pump failure is nearly always fatal. In the unlikely event of Procyrion pump failure, our device's small diameter does not obstruct native blood flow and therefore, will not result in a life threatening event. Additionally, if the pump fails, the system can be easily retrieved and replaced using standard catheter based procedures.
A novel pumping paradigm
Traditional circulatory assist devices are deployed across a valve or bypass entire segments of the native circulation by plumbing one inch holes in the heart and aorta. In contrast, Procyrion's intra-aortic pump utilizes a small diameter axial flow pump and fluid entrainment (aka “jet pumping”) to entrain and efficiently transfer energy to the native aortic flow. Our device supports the natural function of the heart instead of fully replacing it. Fluid entrainment has been used extensively in mining, refrigeration, in-line mixing, and other industrial applications to promote efficient mixing and flow.
Procyrion's intra-aortic pump utilizes fluid entrainment to augment native blood flow resulting an acceleration of fluid, a net increase in cardiac output, and reduced work of the heart through afterload reduction. This partial support system is well suited for patients in NYHA Stage III - early Stage IV heart failure who do not need full cardiac replacement. In addition, the novel fluid entrainment approach enables an extremely low profile design, which is suitable for minimally invasive, trans-catheter deployment and retrieval.