WAYNE, Pa. –(BUSINESS WIRE)– Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in Human PRELUDE Study. The purpose of this prospective, single-arm, multicenter feasibility study is to show the safety and efficacy of the Serranator® Alto device used in the Superficial Femoral Artery (SFA) and/or Popliteal Artery.
The PRELUDE study is led by Principal Investigator Dr. Andrew Holden (Auckland, New Zealand). Other investigators participating in this study are Drs. Marianne Brodmann (Graz, Austria), Marek Krzanowski (Kraków, Poland) and Przemyslaw Nowakowski (Chrzanów, Poland). The centers enrolled 25 subjects and will participate in a 30-day and 6-month follow-up.
“The PRELUDE Trial evaluating the first in human experience of the Serranator® device has rapidly completed enrollment. Excellent acute results were achieved with 100% device success and a very low bail out stent rate despite a significant number of lesions containing chronic total occlusions and severe calcification. Interestingly, IVUS and OCT confirmed serrations were visible in all imaged patients. We look forward to following these patients as the trial progresses,” said Dr. Holden.
The Serranator® Alto device has four external metal serrated strips embedded on a semi-compliant balloon and is designed to create multiple longitudinal lines of interrupted micro-serrations to aid arterial expansion. The device received FDA 510(k) clearance earlier this year. The Serranator® Alto PTA Serration Balloon Catheter is intended for dilatation of lesions in the iliac, femoral, ilio-femoral, and popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. (Not for use in the coronary or neuro-vasculature).
“We are pioneering a new standard of care using Serration Technology with its unique design and mechanism of action. Our next addition to our family of products will be for below-the-knee treatment with the Serranator® Bass, currently in development,” stated Carol A. Burns, President and CEO.
Co-founder, Dr. Peter Schneider commented, “We are impressed with these acute results which showed a reliable increase in lumen gain and arterial expansion. I believe the simple and familiar technique of angioplasty plus the incorporation of Serration Technology in the Serranator® device will continue to prove an effective and valuable tool in treating arterial disease.”
About the PRELUDE Study
For more information regarding the PRELUDE Study visit www.clinicaltrials.gov.