When you fail to drill in the heart, you go offshore. Apparently, that’s what Kirkland, Washington-based Pathway Medical Technologies has done. After the company failed to implement its atherectomy system for coronaries back in 2004, the company pressed ahead, and now it is apparently in possession of a brand new FDA approval for Pathway PV™ Atherectomy System, a peripheral blood vessel clearing device that scrapes and aspirates the gunk at the same time.
Xconomy Seattle is reporting:
Pathway’s FDA application was based on a study of 172 patients in Europe, which found that its device sliced through rock-hard calcium and squishier blockages without tearing or poking any holes in vessel walls. Three patients developed clots or debris that required treatment, which contributed to a serious adverse event rate of 2.9 percent. The effectiveness was eye-opening. Arteries of patients went from 89 percent blocked on average at the beginning of the study to 39 percent clogged after the Pathway device was used, according to data presented in October at the Transcatheter Cardiovascular Therapeutics conference in Washington D.C.
The arteries apparently stay open, too. After six months of follow-up, only about 14 percent of patients required a second procedure, Clement says, compared with about half of patients after traditional balloon angioplasty.