Press Releases
CircuLite® Awarded Grant from Cardiovascular Medical Research and Education Fund to Develop Right-Heart Circulatory Support System for Patients with Pulmonary Arterial Hypertension (PAH)
-New Right-heart Support System is based on the Synergy® Micro-Pump to Address the Needs of High-risk PAH Patients who are Ineligible or at Risk of Dying While Waiting for a Lung Transplant-
SADDLE BROOK, N.J. (January 4, 2012) – CircuLite®, Inc. today announced that it has received a grant from the Cardiovascular Medical Research and Education Fund, Inc. (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 AA 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 centers in Europe, aimed at achieving CE Mark.
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 system's 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.
About Synergy®
Synergy is a miniature ventricular support system that offers the potential of a new minimally invasive treatment option for patients with chronic heart failure who are not responding to standard medical care. The system’s less invasive implant procedure is intended to reduce the surgical risks associated with implant procedures that require cardiopulmonary bypass support. In addition, Synergy is intended to reduce symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance and quality of life.
Synergy's Micro-Pump is the size of a AA battery, circulates up to 4.25 liters of blood per minute, and is intended to reduce the heart's workload while improving blood flow to vital organs. Synergy supplements the heart's native pumping capacity and preserves its ability to respond to the patient's cardiac output demands. The system is surgically implanted using a mini-thoracotomy and the Micro-Pump is placed in a pacemaker-like pocket.
About CircuLite®
CircuLite is developing disruptive solutions to improve the treatment of chronic heart failure. The Company’s minimally invasive circulatory support systems are intended to work in conjunction with the heart to enhance clinical outcomes and improve quality of life for patients and their families. Synergy®, currently in a CE Mark clinical trial, features the world’s smallest surgically implanted blood pump for long-term use in patients diagnosed with heart failure. Next-generation circulatory support systems in development that incorporate CircuLite's micro-pump technology include an endovascular system, a right-heart system, a pediatric system, and an all-support system. For more information, visit our website at www.CircuLite.net.
Contact
Media:
Kari Watson
MacDougall Biomedical Communications
(781) 235-3060 or kwatson@macbiocom.com
CircuLite, Inc.:
Gail Farnan, Vice President, Marketing
(201) 478-7651
CAUTION: Investigational Device. Limited by Federal Law to Investigational Use Only.
CircuLite® and Synergy® are registered trademarks of CircuLite, Inc. in the United States.