CardioGenesis to begin study of ITMR laser system as adjunct to CABG.
This article was originally published in The Gray Sheet
Executive Summary
CARDIOGENESIS MYOCARDIAL REVASCULARIZATION STUDY PATIENT ENROLLMENT commences under an investigational device exemption recently approved by FDA. The prospective, randomized and blinded study, which will include approximately 500 patients in 25 U.S. centers, will contrast patients treated with CardioGenesis' Intraoperative Transmyocardial Revascularization (ITMR) and coronary artery bypass grafts (CABG) with patients treated with CABG alone. Endpoints for the study will be reduction in chest pain and changes in exercise tolerance via a treadmill test. Regional perfusion and quality of life measures also will be evaluated.
You may also be interested in...
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.
Lilly Can Rest Easy As Tirzepatide Scores Phase III Sleep Apnea Win
Topline results from two studies in obstructive sleep apnea among obese adults showed efficacy crossing the 50% threshold that physicians have called clinically meaningful.