CMREF has awarded CircuLite approximately $950,000 to support ongoing work to modify the design of its existing Synergy system so that it can be used to provide circulatory support for a failing right heart, and to conduct two in vivo research studies required to support the systems eventual clinical use. CircuLite is also exploring whether Synergy can be used under Humanitarian Use Designation in the US to provide right-heart support in high-risk PAH patients.
"Synergy was originally designed to supplement the native pumping capacity of the left side of the heart, but the uniquely small pump and 4.25L/min of flow may make the system ideally suited for right-side support," said Paul Southworth, President and Chief Executive Officer of CircuLite. "The ongoing CE Mark study has shown that providing supplemental flow with Synergy unloads the left ventricle and improves hemodynamics, which can translate into important improvements in functional status and quality of life. We believe that modifying Synergy for right-heart support could be similarly beneficial and we look forward to further progressing our development of a right-heart system to address the needs of patients with PAH."
"The issue with trying to use traditional left ventricular assist devices for right-heart support is that these significantly larger pumps generate flow rates that may be too high for patients with PAH," said Daniel Burkhoff, M.D., Ph.D., Chief Medical Officer of CircuLite. "Furthermore, the invasive implantation procedure for traditional LVADs is less than ideal for these very sick patients. Our belief is that only minimal modifications would need to be made to the current Synergy system to optimize it for use as a right-heart support system, and the already less-invasive implantation techniques can be adapted in order to provide a new treatment option for patients who currently have nowhere else to turn."
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension is abnormally high blood pressure in the arteries of the lungs and it is a rare, progressive and fatal disease for which there remains a significant unmet medical need. In cases where the cause is unknown (idiopathic), the condition is rare with an estimated incidence of 1-2 cases per million or approximately 600 new cases per-year in the United States. PAH causes the right side of the heart to work harder than normal and enlarge over time, making it less efficient at pumping blood to the lungs to pick up oxygen. While there are seven approved medical therapies for PAH in the US, none have been clinically shown to significantly affect long-term mortality, halt progression or cause regression of the disease. Patients with advanced-stage disease are typically treated with intravenous prostacyclin or with a percutaneous interventional cardiovascular procedure called atrial septostomy. The only other possible treatment for patients who do not respond to standard medical care is bilateral lung transplantation.
The Synergy® Micro-pump represents a new approach to mechanical circulatory support that is designed to transform chronic heart failure management by providing a less-invasive, elective treatment option for patients before their disease state becomes emergent. Synergy is the first implantable system designed to provide partial circulatory support for long-term use in millions of unserved patients that have NYHA Class IIIb/early Class IV heart failure.
CircuLites patented micro-pump provides up to 4.25L/min of flow, which increases total cardiac output, offloads the heart, allowing it to rest, and potentially enables beneficial recovery of heart function. The size of a AA battery, the device is small enough to be implanted subcutaneously in a "pacemaker-like" pocket through a minimally invasive procedure.
CircuLite is transforming heart failure treatment with the development of minimally-invasive devices for long-term partial circulatory support. By enabling a proactive and lower-risk treatment approach by supplementing a patients native pumping capacity, CircuLite has the potential to improve the quality of life for millions of chronic heart failure patients and their families. CircuLites pipeline is lead by the Synergy® Micro-pump, the worlds smallest implantable blood pump, currently in a CE Mark clinical trial. Next-generation Synergy micro-pumps include an endovascular system, a fully-implantable system and a pediatric system. For more information on CircuLite and the Synergy Micro-pump devices, visit our website at www.CircuLite.net.
CAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only.
Posted by Sean Fenske, Editor-in-Chief, MDT