Dr William A Gray, Columbia University Medical Center, USA, presented the conclusions of the peripheral arterial disease (PAD) intervention with the Pathway Medical Atherectomy System. Gray said that the Pathway adds to the tool set for PAD intervention with the capability to address calcification, thrombus-containing lesions, and in-stent restenosis. “The device presents good stand alone results (PTA only) as demonstrated by low rates of stent usage,” he noted.
According to Gray, Pathway system’s differential cutting tip removes a variety of plaque types, including calcium, and the aspiration ports collect plaque and thrombus. The peripheral vascular disease clinical trial (n=172, with 208 lesions treated) was completed in 2007 in several sites in Germany and formed the data set for FDA approval in 2008. The results showed 99% device success, mean device activation of 3:37 minutes, 33% of procedures stand-alone, 57% used adjunctive balloon and only 7% required adjunctive stent. Five (2.9%) of the 172 patients had major adverse events at 30 days (one target vessel revascularisation, two target limb revascularization and three emboli).