FDA approves Cardiovascular Systems' catheter trial
This article was originally published in Clinica
Executive Summary
Cardiovascular Systems has received a conditional Investigational Device Exemption (IDE) approval from the US FDA to begin a trial of its Diamondback 360° catheter. The catheter, cleared by the FDA in 2007 for the treatment of peripheral arterial disease, will now be tested in the treatment of calcified coronary lesions. A pivotal trial, ORBIT II, will initially enrol up to 100 patients. St Paul, Minnesota-based Cardiovascular Systems estimates the US market for coronary interventions at more than $4bn.