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Home » Merit Products » Clinical Data & Case Reviews » Merit WRAPSODY™ First-in-Human Study

Merit WRAPSODY™ First-in-Human Study

12-Month Published Safety & Performance Results


 

Graph

Results

84.6%
12-Month
Target Lesion
Primary Patency

Download the Study Summary Here >>

Download the Peer-Reviewed CVIR Publication Here >>

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%)
list

Study Details

MR. 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

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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