Eclipse planning mid-summer PMA submission for transmyocardial revascularization laser.
This article was originally published in The Gray Sheet
Executive Summary
ECLIPSE SURGICAL TECHNOLOGIES PMA FOR HOLMIUM TMR LASER SYSTEM is slated to be submitted by mid-summer, the company says. The premarket approval application will seek approval for use of the Eclipse 2000 laser system to perform transmyocardial revascularization to treat patients with severe (Class IV) coronary angina who are not candidates for angioplasty or coronary artery bypass graft surgery (CABG).