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Jan Erik Nordrehaug, who chairs the Department of Heart Disease at University Hospital of Bergen, Norway and is a member of the advisory committee of the Norwegian Ministry of Health, presented favorable preliminary data from the first randomized, double-blinded study of PTMR at the American College of Cardiology (ACC) in Orlando.
Currently PTMR is not cleared by the FDA, and there can be no assurances given that the FDA will clear it.
The BELIEF study is the first double-blinded study of Eclipse's PTMR procedure.
A total of 34 percent of those patients who had the PTMR procedure also experienced a significant lessening in angina, compared to only 13 percent of the other group.
One of the major benefits of the PTMR procedure developed by Eclipse is that it can be performed under a local anesthesia and is less invasive than other laser heart procedures already approved by the FDA, which require a general anesthesia and are performed through a surgical incision.
TMR and TMR plus bypass are performed by a cardiac surgeon and PTMR is performed by a cardiologist in a catheter-based procedure using local anesthesia.
PTMR products are investigational devices and the procedure is currently the subject of clinical trials.
PTMR is an investigational procedure performed by a cardiologist in a catheter-based procedure done under local anesthesia.