When was the first patient implanted with the C-Pulse and so far how many patients have been treated with C-Pulse?
The first patient implanted was in 2005. However, since this time the device has undergone several modifications and improvements to improve the safety, robustness and convenience for the patient and the surgeon. For example, now the device consists of a single unit that comprises the battery and pump which is lighter and quieter, making it more convenient for the patient and the aortic cuff is pre-sutured to save time for the surgeon and reduce the time taken to complete the surgery (currently about 1 hour for minimally invasive procedures).

Our pilot study of 20 patients was completed in 2011 and demonstrated the C-pulse device had a strong safety profile (no serious adverse events - device related deaths, strokes, bleeding), In addition the device showed promising efficacy trends.

Overall patients showed a statistically significant improvement in heart failure status (1.2 Class improvement at 12 months) and quality of life measures . Two patients were permanently disconnected from the device after reporting no further heart failure symptoms and were discharged from a heart failure program. Close to 15 percent of patients were rehospitalised for worsening heart failure at 12 months post implant, compared to 85 percent re-hospitalisation rate for the same patients in the 12 months prior to receiving implant.

Drug Therapy improvements. All patients were either discontinued, reduced or unchanged from their diuretic drug therapy. All four patients who were receiving inotropes were successfully weaned within 48 hours of receiving the device. Improvements in Ejection Fraction and Left Ventricular End Diastolic Diameter (LVEDD or heart size). Currently, the device has only been approved for sale in Europe following awarding of CE Mark in July this year.

Will C-Pulse be available to the patients directly or through prescription only?
The C-pulse device will not be available to patients directly. The patients need to consult with their cardiologist about whether C-pulse device might be an effective therapeutic option for them.

Which is the biggest market for C-Pulse?
Class III and ambulatory class IV heart failure. These patients represent about 25 percent of the heart failure patients. Medtech analysts who cover the cardiovascular market and have written research on Sunshine Heart (Craig Hallum, Canacord, Cowen, RBS Morgans) have estimated the conservative market for the C-pulse device is in excess of $2.5 Bn (this is based on current device costs and conservative penetration).