The American Heart Association estimates that over 10 million people in the United States suffer from the chest pain & pressure of angina with 400,000 new cases of chronic stable angina each year as a result of coronary and ischemic heart disease. Furthermore, the Heart Failure Association of America now considers coronary artery disease to be the leading cause of chronic heart failure in the US.49
While a majority of patients can be treated by traditional interventional or surgical therapies, such as drug eluting stents or coronary artery bypass, some patients will require less traditional forms of treatment. In fact, a recent study from the Minneapolis Heart Institute shows that over 6% of patients with medically refractory chronic stable angina are not amenable to traditional revascularization options but may be candidates for other forms of revascularization.50 It is these patients that Cardiogenesis seeks to help through a broad range of devices for the treatment of angina pain.
Specific guidelines for patient selection include the following criteria:
- Refractory but stable severe angina despite maximum medical management
- Ejection fraction >25%
- Objectively demonstrated diffuse CAD
- Region of myocardium with reversible ischemia not amenable to CABG or PCTA
Since its approval by the FDA, over 45,000 patients suffering with the profound physical limitations and chest pain related ischemic heart disease have been treated with laser transmyocardial revascularization TMR.