Multicentre EECP CHF (congestive heart failure) trial gains FDA go-ahead:
This article was originally published in Clinica
Executive Summary
Vasomedical has received US FDA approval, with conditions, to perform a multicentre, controlled study of its enhanced external counterpulsation (EECP) therapy in congestive heart failure patients. The 18-centre study will assess EECP therapy, which involves wrapping pressurised cuffs around a patient's legs, in 180 subjects. The Westbury, New York company also said that the FDA has classified the EECP system as a Class III PMA device when used in the treatment of CHF.