First Patient Enrolled in Merit Medical’s WRAPSODY™ Registry (WRAP) Study
July 05 2022 - 12:02PM
Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global
manufacturer and marketer of healthcare technology, announced today
the successful enrollment of the first patient in its WRAP Registry
Study. This study will evaluate the clinical benefits associated
with the use of the WRAPSODY Cell-Impermeable Endoprosthesis in
patients receiving hemodialysis that experience a narrowing
(stenosis) or blockage (occlusion) of blood vessels required for
dialysis (vascular access).
Globally, over two million patients with
advanced kidney disease receive dialysis.1 Hemodialysis, the
primary approach used for dialysis, requires long-term vascular
access that is typically achieved through the surgical creation of
an arteriovenous fistula (AVF) or placement of an arteriovenous
graft (AVG). However, complications, such as stenosis and/or
occlusion within the dialysis outflow circuit of an AVF or AVG, can
impair vascular access which compromises the ability to provide
adequate dialysis treatment. The WRAPSODY Cell-Impermeable
Endoprosthesis was created to help overcome this challenge by
maintaining the integrity of the dialysis outflow circuit.
Dr. Dean Huang, consultant diagnostic and
interventional radiologist at King’s College Hospital in London,
England, enrolled the first patient in the WRAP Registry. “The
patients being treated with the WRAPSODY Cell-Impermeable
Endoprosthesis have historically had few clinical options,” Dr.
Huang said. “These patients have typically faced frequent
reinterventions to maintain vessel patency resulting in multiple
procedures and hospitalizations. The WRAP study will add to the
growing body of evidence on WRAPSODY’s ability to achieve durable
outcomes for this vulnerable patient population. We are excited to
enroll the first patient in this important study.”
The WRAP Registry Study will enroll up to 500
patients with outflow circuit stenosis or occlusion who are
receiving hemodialysis at medical facilities throughout Europe,
South America, Australia, and New Zealand. Clinical outcomes of
patients after the initial placement of the WRAPSODY
Cell-Impermeable Endoprosthesis will be evaluated over a two-year
period in accordance with the instructions for use associated with
its CE Mark.
“Enrollment of the first patient in the WRAP
Registry Study will expand our clinical portfolio of evidence
establishing the therapeutic benefits of the WRAPSODY
Cell-Impermeable Endoprosthesis and provide real-world insight that
can help improve the care for patients receiving hemodialysis
worldwide,” said Fred P. Lampropoulos, Merit Medical’s Chairman and
CEO.
The WRAPSODY Cell-Impermeable Endoprosthesis is
an expandable nitinol stent frame fully enveloped by an external
layer of expanded polytetrafluoroethylene (PTFE) and an internal
layer of spun PTFE with an interposed cell-impermeable layer. The
WRAPSODY Cell-Impermeable Endoprosthesis system is being studied
under an Investigational Device Exemption in the United States. It
previously received the CE Mark and complements other vascular
access products distributed by Merit Medical Systems, Inc.,
including the HeROâ Graft, Super HeRO® Adapter and Support Seal
system, and CentrosFLOâ Hemodialysis Catheter.
WRAPSODY is not approved, cleared, or available
for commercial distribution in the United States and may not be
approved, cleared, or available for sale or use in other countries.
For additional information on the WRAP Registry Study, including
ongoing updates, please visit
https://www.clinicaltrials.gov/ct2/show/NCT05062291
ABOUT MERIT MEDICAL
Founded in 1987, Merit Medical Systems, Inc. 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. Merit serves
client hospitals worldwide with a domestic and international sales
force and clinical support team totaling more than 600 individuals.
Merit employs approximately 6,500 people worldwide.
TRADEMARKS 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.
CONTACTS PR/Media Inquiries Sarah Comstock Merit
Medical +1-801-432-2864 | sarah.comstock@merit.com
Investor Inquiries Mike Piccinino, CFA, IRC
Westwicke - ICR +1-443-213-0509 |
mike.piccinino@westwicke.com
Reference
- Liyanage T, Ninomiya T, Jha V, Neal
B, Patrice HM, Okpechi I, et al. Lancet.
2015;385(9981):1975-82.
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