Updated on 2 November 2012
Heart Failure is the leading cause of re-hospitalisation in the developed world with 25 percent of patient re-hospitalised for worsening heart failure after 30 days and 50 percent of Class III/IV heart failure patients are re-hospitalised by six months.
In the US, the heart failure related re-hospitalisation rate is such an economic burden, that in October this year the Affordable Care Acts Hospital Readmission Reduction Program was instituted and includes a penalty system to incentivize hospitals to ensure their heart failure related rehospitalisation rates meet a defined benchmark rate of less than 24.7 percent at 30 days. If hospitals exceed this benchmark then they risk repayment of reimbursements as a penalty. As such, we believe any approach that allows hospitals to reduce heart failure related re-hsopitalisation will be actively supported by hospitals.
In our pilot study trial, at least 17 of the 20 patients had been hospitalized due to worsening heart failure in the year prior to receiving our implant. Post implant, the re-hospitalisation rate at 12 months was 15 percent. Reducing this clinical and economic burden is such a priority that the FDA have approved the primary endpoint for our clinical trial with the C-pulse device to be the demonstration of a reduction in hospitalization rate due to worsening heart failure or heart failure related mortality. Other cost effective benefits we believe the C-pulse device offers compared to Class IV devices is:
In our pilot study, the average number of days in hospital was nine compared to 19 for patients who received a Left Ventricular Assist Device (LVAD). Our average number included those patients who received the C-pulse device both via minimally invasive approach and via a thoracotomy (which is a more invasive and requires additional post-operative care). Those patients who receive the C-pulse device implanted in a minimally invasive manner only require approximately four days in hospital.
Our device is currently sold for US$59,000 while it's being evaluated in premarketing and post marketing clinical trials, which is significantly lower than Class IV devices such as LVAD devices which cost in the order of US$150,000 and is in excess of the medicare/payer reimbursement level for these devices/procedures ($130,000).