Facts and Figures
Chronic heart failure is a leading cause of death in the developed world, estimated to impact over 20 million people at any one time. While symptoms can often be treated, the underlying process is largely irreversible.
|In the UK, heart failure affects close to a million patients with over 60,000 new cases diagnosed each year. The prognosis is extremely poor with nearly 40% of people diagnosed dying within one year. Annual mortality is around 25,000 – equivalent to over 5% of all deaths in the UK1 British Heart Foundation statistics – heart failure supplement 2002 (latest available) and BHF website: www.bhf.org.uk.. It is estimated that the management of heart failure consumes 2% of the total annual NHS budget2 Stewart S, Jenkins A, Buchan S, McGuire A, Capewell S, McMurray JJ: The current cost of heart failure to the National Health Service in the UK. Eur. J. Heart Fail. 4 (3) June 2002: 361–71.|
|In the USA there are about 5.7 million people suffering from heart failure, with a five-year mortality rate of over 50%. 550,000 new cases and over 1 million hospitalisations are reported each and year and numbers are rising. Annual mortality is around 100,000 per year. It is estimated that the direct and indirect cost of heart failure in the US was $39.2 billion in 20103 AHA stats = American Heart Association – Heart Stats 2010 update. 100,000 deaths estimate based on 282,754 any mention mortality and 60,337 underlying cause mortality.|
|Advanced heart failure is characterised by advanced structural heart disease and severe symptoms at rest, despite detailed medical or cardiac resynchronisation therapy. Exercise intolerance and fatigue are debilitating and quality of life is extremely poor. There are currently more than 300,000 advanced heart failure patients in the USA, 60,000 in the UK and 2.2 million worldwide. 20% are under 65 years of age4 Westaby S: Destination Therapy: Time for Real Progress. Nature Reviews Cardiology, August 2008 No5 (8) 477-483.|
Advanced heart failure patients are the target population for Calon’s MiniVADTM. Taking into account likely ineligibility due to co-morbidities and other factors, credible estimates for the annual number of Ventricular Assist Devices (VADs) required are:
- 40k – 100k in the USA5 Westaby S: Report from a Society of Thoracic Surgeons (USA) and Food and Drugs Administration (FDA) “Think Tank” into future developments in long term mechanical circulatory support. Washington September 2011,6 Rogers G: Are LVADs Ready to be Mainstream. Thoratec Corp company presentation
- 60k – 150k in Europe7 Foster G: Calon Calon Cardio Technology Ltd Business Plan Oct 2011
- 160k – 400k in the developed world7 Foster G: Calon Calon Cardio Technology Ltd Business Plan Oct 2011
With these figures in mind, the market need is substantial and arises from the inability of traditional therapies to address the enormous clinical need from advanced heart failure. Existing VADs have yet to make significant impact on the market and even in the most developed market, the USA, VADs have currently achieved less than 10% market penetration8 Cannacord Genuitly via Medical Device Daily. This is due to high device costs, significantly invasive surgery and higher than expected complication rates – factors which the Calon’s MiniVADTM aims to comprehensively address.
However, existing devices have proved the efficacy and potential of VADs, and have made excellent progress in educating the clinical community to the benefits of VAD therapy. This will allow Calon to enter a maturing yet still rapidly growing market with what is expected to be a technically superior and more cost effective product offering.
Disclaimer: Calon Cardio's VAD devices are not available for sale in the United States of America