CardioGenesis Heart Laser Device Faces Key Review
Medical products maker CardioGenesis Corp. will appear before a US Food and Drug Administration advisory panel on Monday to tout its newest laser device for percutaneous myocardial revascularization.
CardioGenesis’ new device, already sold in Europe and Asia, is designed to be less invasive by enabling surgeons to thread a catheter through a femoral artery. An older laser device made by the Foothill Ranch, California company requires an open procedure.
On Monday, CardioGenesis is set to present results from clinical trials of the new device, called Axcis, to an advisory panel. The committee is expected to scrutinize data on safety and efficacy and then vote on whether to recommend approval for Axcis.
The company will present clinical trial data showing that the device eased pain and improved exercise tolerance. About 1,000 percutaneous myocardial revascularization procedures per year are performed with the CardioGenesis device in Europe, and about 5,000 procedures take place each year with the older device, CardioGenesis Chairman, President and Chief Executive Michael Quinn told Reuters.
