Avinger announced on 12 March that it has completed enrolment of its VISION clinical study, which is designed to evaluate the safety and efficacy of the company’s Pantheris system. According to Avinger, the Pantheris catheter is the only device to combine directional atherectomy with real-time intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries.
In July 2014, the FDA granted Avinger an investigational device exemption for Pantheris and the company commenced enrolment of a 133-patient trial in the USA and Europe. The company expects to present interim 30-day data in the second quarter and six-month data in the fourth quarter of 2015. Primary safety and efficacy endpoint analysis results will be used to support a 510(k) application with the FDA, anticipated to be filed in the second half of 2015.
“Completing enrolment for the VISION trial is a significant clinical milestone for Avinger and more importantly a key development for patients suffering from peripheral arterial disease. We are extremely grateful for the collaboration of our clinical investigators who supported timely enrolment in this groundbreaking study,” said John B Simpson, founder and executive chairman of Avinger. “Pantheris is designed to provide physicians with a better understanding of arterial narrowings in real time, which we believe will significantly improve peripheral arterial disease patient outcomes. We believe we are on track to meet or exceed the required primary safety and efficacy endpoint requirements of the study, and plan on filing our 510(k) application for Pantheris later this year after six month follow-up data is available.”
“Participation in the VISION trial has been not only a privilege but an eye-opening experience. Never before have we had this much information available, in real-time, about the disease and structures on the inside of the artery,” said lead enroller, Barry Tedder, interventional cardiologist of St Bernards Hospital, Jonesboro, USA. “I believe that the Pantheris catheter for atherectomy and the lumivascular approach more broadly have the potential to revolutionise the treatment of vascular disease.”
VISION is a non-randomized, prospective, global, single-arm clinical trial that is evaluating the safety and effectiveness of the Pantheris catheter to perform directional atherectomy while using intravascular imaging to aid in the removal of plaque from diseased lower extremity arteries. As part of the trial, an independent group of physicians will review the angiography results for each patient treated to determine Pantheris’ efficacy. An independent Clinical Events Committee is reviewing and adjudicating all primary safety endpoint data.