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Laser Myocardial Therapies Under The Beam In Light Of J&J DIRECT Results

This article was originally published in The Gray Sheet

Executive Summary

Results of a Johnson & Johnson-sponsored trial showing that direct myocardial revascularization (DMR) technology has a placebo-comparable effect should prompt FDA to take a closer look at laser therapies for advanced heart disease patients, trial investigators suggest.

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PMR Adverse Events, Elusive Efficacy Endpoints Cited In Panel Rejection

The reliance on hospitalization for angina as a safety endpoint in the clinical trials of CardioGenesis' Eclipse PMR (percutaneous myocardial revascularization) device masked the rate of significant adverse events related to the procedure, according to FDA's Circulatory System Devices Panel.

PMR Adverse Events, Elusive Efficacy Endpoints Cited In Panel Rejection

The reliance on hospitalization for angina as a safety endpoint in the clinical trials of CardioGenesis' Eclipse PMR (percutaneous myocardial revascularization) device masked the rate of significant adverse events related to the procedure, according to FDA's Circulatory System Devices Panel.

BELIEF Data May Dispel "Placebo Effect" Shadow Over Eclipse PTMR

Results from the "Blinded Evaluation of Laser 'PTMR' Intervention Electively For angina pectoris" (BELIEF) trial may represent a key step in restoring faith in the clinical efficacy of percutaneous transmyocardial revascularization and dispelling doubts raised that the therapy has no benefits beyond a placebo effect.

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