Merit Medical Announces Positive Results in First-in-Human Study of WRAPSODY Cell-Impermeable Endoprosthesis

Prospective, observational study published in CardioVascular and Interventional Radiology¹ reports 100% target lesion primary patency (“TLPP”) rate without reintervention through 30 days, with a 12-month TLPP rate of 84.6% and a 12-month access circuit primary patency (“ACPP”) rate of 65.9%.

Authors conclude the results suggest WRAPSODY Endoprosthesis is a safe and effective treatment for arteriovenous access circuit stenosis.

SOUTH JORDAN, Utah, Sept. 20, 2021 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading manufacturer and marketer of proprietary medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today positive results from a prospective, observational, first-in-human study to evaluate the safety and effectiveness of the Merit WRAPSODY Endoprosthesis. The WRAPSODY Endoprosthesis is a self-expanding, cell-impermeable endoprosthesis designed for the treatment of arteriovenous (“AV”) fistula access circuit stenosis and AV graft access circuit stenosis.

The WRAPSODY FIRST Study enrolled 46 subjects with clinically relevant stenosis, who were treated at three centers. The eligible population consisted of patients undergoing hemodialysis through an AV circuit with clinical and radiological evidence of stenosis at the graft-vein anastomosis, in the peripheral outflow veins or in the central veins up to the superior vena cava. The subjects did not have clinically relevant secondary stenosis or thrombus in the access circuit.

The study reported anatomical, clinical and procedural success in all cases. The primary safety outcome measure was the proportion of subjects without localized or systemic safety events affecting the access circuit that resulted in surgery, hospitalization or death during the first 30 days following device placement. All but one subject was free from such a safety event in the first 30 days following device placement (97.8%). The safety event was adjudicated as not related to the device or study procedure. Over the remainder of the study, there was one adverse event adjudicated as possibly device-related.