Cagent Vascular Presents Positive Results from the PRELUDE Study at LINC 2018

WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular interventions announces positive results from the First-in-Human PRELUDE Study. Dr. Andrew Holden (Auckland, New Zealand), Principal Investigator, presented 30-day and preliminary 6-month results using the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter at the Leipzig Interventional Course last week.

The PRELUDE Study is a prospective, single-arm, multicenter feasibility study designed to show safety and efficacy of the Serranator® device used in critical lesions in the superficial femoral artery (SFA) and/or popliteal arteries. The study enrolled 25 subjects at centers in New Zealand and Europe.

“The fascinating part of the trial is that although we had patients, by definition, who were excluded with severe calcification, there was a significant core lab adjudicated group of persons who had lesions with moderate to severe calcification. We could achieve luminal gain to nominal using very low pressures in that subgroup which tells us that this is something quite different from plain balloon angioplasty. Not only being able to dilate these vessels to nominal, which is an achievement on its own, but to do it without a significant incidence of dissection is an achievement. Although the numbers are small this is a really encouraging sign that the serration mechanism of action is a very different way of treating the artery,” said Dr. Holden.

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