Merit WRAPSODY™ Endoprosthesis - Clinical Data

Maintain Long-Term Vessel Patency - Merit WRAPSODY

— FIRST IN HUMAN STUDY —

12-MONTH PUBLISHED SAFETY & PERFORMANCE RESULTS

RESULTS

SAFETY n/N (%) SUMMARY OF EVENTS
30-Day Freedom from Safety Events 45/46 (97.8%) Thrombosis of access circuit – DMC/CEC adjudicated as not device related
Device-related AEs 1 Thrombosed fistula – Adjudicated as possibly device-related, access not salvageable so no imaging to assess relatedness

 

Target Lesion Primary Patency

TLPP AVF PERIPHERAL AVG PERIPHERAL AVF ANASTOMOSIS AVF/AVG CENTRAL TOTAL
6 Month 16/16 (100%) 9/10 (90%) 8/8 (100%) 9/9 (100%) 42/43 (97.7%)
12 Month 11/14 (78.6%) 6/7 (85.7%) 7/9 (77.8%) 9/9 (100%) 33/39 (84.6%)

 

Access Circuit Primary Patency

ACPP AVF PERIPHERAL AVG PERIPHERAL AVG ANASTOMOSIS AVF/AVG CENTRAL TOTAL
6 Month 13/16 (81.3%) 9/10 (90%) 8/8 (100%) 8/11 (72.7%) 38/45 (84.4%)
12 Month 10/15 (66.7%) 7/10 (70%) 5/8 (62.5%) 7/11 (63.6%) 29/44 (65.9%)

STUDY DETAILS

Mr James Gilbert - First in Human Study with the Merit WRAPSODY EndoprosthesisMR. JAMES GILBERT

Principal Investigator

Consultant Transplant & Access Surgeon

Oxford University Hospitals (United Kingdom)

DESIGN PURPOSE SUBJECT POPULATION PRIMARY STUDY OBJECTIVES FOLLOW-UP
• Prospective
• 3 Centre
• Single arm
Safety & effectiveness of WRAPSODY in treatment of stenosis or occlusion within dialysis access circuit 46 Haemodiaylsis patients
• AV fistula (AVF)
• AV graft (AVG)

Clinical relevant stenosis or obstruction (≥ 50%) without additional thrombus or 2° lesions

Safety: Proportion without any localised or systemic safety events through 30 days affecting the access or venous outflow circuit and resulted in surgery, hospitalisation, or death

Effectiveness: Proportion with TLPP at 30 days

30 Days, 3 Months, 6 Months & 12 Months

Independent DMC/CEC adjudicated
• Reinterventions
• device/procedure-relatedness for adverse events

Download the study summary here >>

CONCLUSIONS1

  • “Study device can safely and effectively treat stenoses in the peripheral outflow and central veins of AV access circuits.”
  • “6- and 12-month TLPP and ACPP rates were unexpectedly high.”
  • “While needing further confirmation, the study device’s design may be a contributing factor in limiting restenosis.”
  • “This degree of patency preservation should reduce revision frequency and access abandonment rates, leading to less hospitalisation and lower healthcare costs.”
  • “Additional follow-up in larger RCTs is needed to verify these results.”

Read the full study here >>

 

Request Information

NEXT STEPS

  • Wrapsody WAVE Study (NCT04540302)
    • Multi-Cohort, Multi-Centre trial
    • AVF peripheral: RCT, N = 244, 1:1 vs PTA
    • AVF/AVG central: RCT, N = 120, 1:1 vs PTA
    • AVG venous anastomosis: PG, N = 113
  • Global WRAP Registry
    • Real world clinical data
    • Up to 50 centres to participate
    • Up to 500 patients to be enrolled

VIDEO HIGHLIGHT

Prospective First in Man Study of the Merit WRAPSODY Endoprosthesis
for the Treatment of Haemodialysis Access Circuit Stenosis

First In Man Study Analysis - Merit WRAPSODY

This product is intended for sale and/or use in various regions outside of the United States of America, 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. This product 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.

Publication References

  1. Gilbert J, et al.; CardioVascular and Interventional Radiology (2021). https://doi.org/10.1007/s00270-021-02953-8
  2. Falk A, Maya ID, Yevzlin AS; RESCUE investigators. A prospective, randomized study of an expanded polytetrafluoroethylene stent graft versus balloon angioplasty for in-stent restenosis in arteriovenous grafts and fistulae: two-year results of the RESCUE study. J Vasc Interv Radiol. 2016;27:1465-1476
  3. Vesely T, DaVanzo W, Behrend T, et al. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64:1400-1410.e1.
  4. W. L. Gore & Associates Inc. Viabahn Endoprosthesis Instructions For Use. January 2021 Reference 20023402
  5. Bard Peripheral Vascular. Covera vascular covered stent instructions for use. Rev.4 / 08-18. http://www.bardpv.com/eifu/uploads/BAWB05872R4-Covera-Vascular-Covered-Stent-IFU.pdf. Accessed October 10, 2021.
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