Over 1.2 million Percutaneous Cardiac Intervention (PCI) procedures are performed each year in the US., During PCI, myocardial perfusion is a critical indicator of heart health and an indication of successful PCI. It has been estimated up to 20% of PCI fails to attain myocardial perfusion. Chest pain symptoms and non-invasive techniques, such as exercise electrocardiography (ECG) testing, have limited clinical significance for evaluating the efficacy of PCI and detecting restenosis which reduces myocardial perfusion. Chest pain following PCI is a poor indicator of restenosis since asymptomatic restenosis occurs in 18% to 59% of patients following PCI and in 30% to 58% of patients after stent placement, while up to 45% of patients developing chest pain after PCI do not have angiographic restenosis., Current techniques exist to measure myocardial perfusion require expensive imaging technologies and are not available during the PCI procedure.
Therefore, during PCI there exists a need for a continuous non-invasive myocardial perfusion monitor which provides real-time perfusion information to the cardiologist.
The CorSens Perfusion Monitor has received FDA 510(k) Pre-Market Clearance for the continuous non-invasive detection of myocardial perfusion.