FDA panel review date set for PMR (percutaneous myocardial revascularisation) therapy:
This article was originally published in Clinica
A US FDA advisory panel is to review a PMA application for a minimally invasive heart laser technique for relieving angina. The percutaneous myocardial revascularisation (PMR) method, developed by Sunnyvale, California-based Eclipse Surgical Technologies, will be assessed by the agency's circulatory system devices panel on July 9. PMR has been shown in recent clinical trials to significantly reduce angina, says Eclipse, which already has US approval for a surgical version of the treatment. Minimally invasive heart laser therapy came under scrutiny last year, after Biosense Webster, another firm involved in the heart laser field, released poor results from its direct myocardial revascularisation study (see Clinica No 941, p 31).