Treating Chronic Heart Failure
In a majority of cases, there is no cure for heart failure. Heart transplantation is available to only 2,500 patients per year in the U.S. Therefore, heart failure is most often managed with a combination of therapies, including life style changes such as improved diet and exercise, medications, devices and/or surgeries. As patients’ disease progresses, fewer treatment options are available and there remains a significant unmet need for patients diagnosed with NYHA Class IIIb/early Class IV (INTERMACS 4-6) heart failure who no longer benefit from cardiac resynchronization with pacemakers and defibrillators, but are not yet candidates or eligible for heart transplant.
CircuLite is filling this treatment gap with a disruptive technology approach that has the potential to turn heart failure into a manageable disease, addressing two million patients that are not currently being optimally addressed. CircuLite’s miniature circulatory support systems have potentially significant benefits over currently available full-support VADs. These miniature devices are designed to be implanted via less invasive mini-thoracotomy or endovascular procedures, without the need for sternotomy or cardio-pulmonary bypass. CircuLite’s devices feature an adjustable speed and associated flow rate, so they may be used to meet the circulatory support needs of less-sick patients as well as end-stage patients who are waiting for a heart transplant. They can be designed to supplement the heart’s native pumping capacity in less-sick patients, rather than completely replacing heart function as a VAD does, or can be adjusted to take over function of the heart in patients that need full support. A supplementary approach in less-sick patients preserves the heart’s ability to respond to the patient’s cardiac output demands and improves blood flow, while also reducing the heart’s workload, potentially allowing the heart to rest and remodel. An important feature of the Synergy system is its ability to work in conjunction with the patient’s native remaining heart function. In the event of accidental power disconnection, most patients should be supported by their remaining cardiac output until power can be restored to the system.
Recent reports have indicated that while circulatory support in less-sick patients is medically justified, there is significant concern among clinicians about the invasiveness of current device implant procedures. CircuLite’s circulatory support systems may represent less-invasive treatment options to address a range of patient needs.