Merit Medical Announces Positive Results in First-in-Human Study of WRAPSODY™ Cell-Impermeable ...
Prospective, observational study published in CardioVascular and Interventional Radiology1reports 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.
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%.)
“Early first-in-human study results show that the Merit WRAPSODY Endoprosthesis can be safely used to treat stenoses at key sites within a dialysis access circuit,” said the study’s primary investigator, James A Gilbert BMBS, MA (Ed), FRCS (Gen), FRCS Ed; Consultant and Transplant & Vascular Access Surgeon, Vascular Access Lead, Oxford University Hospitals. “Even more encouraging are the very promising primary one-year target lesion patency rates of 84.6% and access circuit patency rate of 65.9%. To my knowledge, these are higher than any other published data and suggest that the novel features of the WRAPSODY Endoprosthesis may have a key role in preserving the longevity of precious dialysis access for our patients.”
Merit is also conducting a large multinational, multicenter study, identified as the WAVE Study, which it plans to use to support a premarket approval application to the United States Food & Drug Administration. Enrollment in the randomized WAVE Study comparing the Merit WRAPSODY Endoprosthesis to percutaneous transluminal angioplasty for treatment of venous outflow circuit stenosis or occlusion in hemodialysis patients began in March 2021. Merit anticipates that the WAVE Study will include 477 subjects.
“Merit has built its commercial legacy on innovative products that benefit patients and advance standards of care,” said Fred P. Lampropoulos, Merit’s Chairman and CEO. “We are encouraged by the WRAPSODY FIRST Study’s positive results and excited to help shape the future of arteriovenous access circuit stenosis treatment. We look forward to assessing future study results regarding the Merit WRAPSODY Endoprosthesis, and to making a positive impact in the lives of patients suffering from kidney disease.”
Founded in 1987, Merit Medical Systems, Inc. is 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. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals. Merit employs approximately 6,300 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit’s plans and expectations with respect to the WRAPSODY FIRST Study and the potential impact, scope, duration and outcome of that study, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties such as those described in Merit’s Annual Report on Form 10-K for the year ended December 31, 2020 (the “2020 Annual Report”) and other filings with the U.S. Securities and Exchange Commission (the “SEC”). Such risks and uncertainties include inherent risks and uncertainties relating to Merit’s internal models or projections, including those related to the WRAPSODY FIRST Study; risks and uncertainties associated with the COVID-19 pandemic and Merit’s response thereto; disruptions in Merit’s supply chain, manufacturing or sterilization processes; risks relating to Merit’s potential inability to successfully manage growth through acquisitions generally, including the inability to effectively integrate acquired operations or products or commercialize technology developed internally or acquired through completed, proposed or future transactions; negative changes in economic and industry conditions in the United States or other countries; risks and uncertainties associated with Merit’s information technology systems, including the potential for breaches of security and evolving regulations regarding privacy and data protection; expenditures relating to research, development, testing and regulatory approval or clearance of Merit’s products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; litigation and other judicial proceedings affecting Merit; restrictions on Merit’s liquidity or business operations resulting from its debt agreements; infringement of Merit’s technology or the assertion that Merit’s technology infringes the rights of other parties; actions of activist shareholders; product recalls and product liability claims; changes in customer purchasing patterns or the mix of products Merit sells; increases in the prices of commodity components; the potential of fines, penalties or other adverse consequences if Merit’s employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations, including reforms to the procedures for approval or clearance of Merit’s products by the U.S. Food & Drug Administration or comparable regulatory authorities in other jurisdictions; changes in tax laws and regulations in the United States or other countries; termination or interruption of relationships with Merit’s suppliers, or failure of such suppliers to perform; fluctuations in exchange rates; concentration of a substantial portion of Merit’s revenues among a few products and procedures; development of new products and technology that could render Merit’s existing or future products obsolete; market acceptance of new products; volatility in the market price of Merit’s common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; failure to introduce products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referenced in the 2020 Annual Report and other materials filed with the SEC. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results. Those estimates and all other forward-looking statements included in this document are made only as of the date of this document, and except as otherwise required by applicable law, Merit assumes no obligation to update or disclose revisions to estimates and all other forward-looking statements.
Unless noted otherwise, trademarks and registered trademarks used in this release are the property of Merit Medical Systems, Inc. and its subsidiaries in the United States and other jurisdictions.
1 References: Gilbert, J., Rai, J., Kingsmore, D. et al. First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients. Cardiovasc Intervent Radiol (2021). https://doi.org/10.1007/s00270-021-02953-8
To learn more about the WRAPSODY Endoprosthesis, please visit: https://www.merit.com/peripheral-intervention/access/renal-therapies-accessories/merit-wrapsody/
Disclaimer: The WRAPSODY Endoprosthesis is intended for sale and/or use in the European Union, for use in haemodialysis patients for the treatment of stenosis or occlusion within the dialysis outflow circuit of an arteriovenous (AV) fistula or AV graft. The WRAPSODY Endoprosthesis is not approved, cleared or available for sale or use in the United States and may not be approved, cleared or available for sale or use in other countries. Before using any product, refer to the Instructions for Use (“IFU”) for indications, contraindications, warnings, precautions, and directions for use.
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