Updated on 2 November 2012
The device has been trialed in 20 patients with moderate to severe heart failure which demonstrated that the device had both a strong safety profile and was able to provide symptomatic relief for Class III/ambulatory class IV heart failure patients.
How is C-Pulse different from the other solutions that are available to treat clinical symptoms associated with class III and class IV heart failure?
Heart failure is a progressive disease. Patients with class III heart failure have been given drug therapy such as beta blockers, diuretics and ACE inhibitors and resynchronization therapy (if indicated), yet they are still symptomatic and their heart failure has continued to progress. Class III heart failure patients are symptomatic even with mild exertion and suffer symptoms such as dizziness and shortness of breath.
Walking to the letterbox would be difficult for these patients and so their quality of life is severely compromised. Following drug therapy and cardiac resynchronization therapy, the only other treatment option for heart failure patients are life supporting devices such as left ventricular assist devices (LVAD's), artificial hearts and heart transplants.
These treatments are considered heroic measures, are highly invasive and carry risk of serious adverse events (clots, bleeding, stroke, death) and only implemented when the patient is in class IV heart failure and at risk of imminent death. For class III heart failure patients, who are refractory to drug therapy, there is no current treatment option, they are simply left to get worse and progress to class IV.
Please tell our readers about how cost-effective is C-Pulse?
While a precise cost benefit analysis cannot yet be determined as we are still in clinical trial stage in the US and have not yet had reimbursement approval in Europe, there are a number of metrics that we believe demonstrate the economic benefit trend of the C-pulse device: