Merit Medical Announces Positive Results in First-in-Human Study of WRAPSODY™ Cell-Impermeable Endoprosthesis
September 20, 2021 at 09:25 am EDT
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Merit Medical Systems, Inc. announced 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. The primary effectiveness outcome measure for the study was the TLPP rate at 30 days following device placement, which was 100%. At 6 months following device placement, the TLPP rate was 97.7% and at 12 months following device placement, it was 84.6%. The 6- and 12-month ACPP rates were 84.4% and 65.9%, respectively. TLPP rates were similar regardless of access type and lesion location or whether subjects were treated with a single device or overlapping devices. In all cases, reintervention at the target lesion was successful in maintaining patency (12-month assisted TLPP rate of 100%.).
Merit Medical Systems, Inc. designs, develops, manufactures, markets and sells medical products for interventional and diagnostic procedures. The Company is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Its cardiovascular segment consists of four product categories: peripheral intervention, cardiac intervention, custom procedural solutions and original equipment manufacturer. Within these product categories, it sells a variety of products, including cardiology and radiology devices, as well as embolotherapeutic, cardiac rhythm management, electrophysiology, critical care and others. Its endoscopy segment consists of gastroenterology and pulmonology devices which assist in the palliative treatment of expanding esophageal, tracheobronchial and biliary strictures caused by malignant tumors.
MERIT MEDICAL SYSTEMS, INC. 
