CircuLite announced that it has received a grant from the Cardiovascular Medical Research and Education Fund (CMREF) to fund the development of a right-heart circulatory support system based upon CircuLite’s Synergy Micro-pump for the treatment of right heart failure due to pulmonary arterial hypertension (PAH) and other causes.
The Synergy system includes a micro-blood pump the size of a double A battery that can be implanted superficially in a “pacemaker-like” pocket. Synergy is the first and smallest surgically implanted device designed for partial circulatory support (up to 4.25L/min) in patients with heart failure. CircuLite is currently conducting a clinical trial with Synergy in patients with Class IIIB/early Class IV heart failure at multiple centres in Europe, aimed at achieving CE mark.
CMREF has awarded CircuLite approximately US$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 system’s eventual clinical use. CircuLite is also exploring whether Synergy can be used under humanitarian use designation in the USA to provide right-heart support in high-risk pulmonary arterial hypertension 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 CEO of CircuLite. “The ongoing CE mark study has shown that providing supplemental flow with Synergy unloads the left ventricle and improves haemodynamics, 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 pulmonary arterial hypertension.”
“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 pulmonary arterial hypertension,” said Daniel Burkhoff, 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 optimise 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.”