CardioGenesis to begin study of ITMR laser system as adjunct to CABG.
This article was originally published in The Gray Sheet
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...
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.