Medtronic Enrolls First Patient in Study of IN.PACT(TM) AV Access Drug-Coated Balloon in Patients with End-Stage Renal Disease
25 May 2017 - 2:13AM
DUBLIN - May 24, 2017 -
Medtronic plc (NYSE: MDT) today announced that the first patient
has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon
(DCB) study for use in patients with end-stage renal disease
(ESRD). The U.S. Food and Drug Administration (FDA) approved the
investigational device exemption (IDE) study to evaluate the safety
and efficacy of IN.PACT(TM) AV Access DCB as a treatment for
failing arteriovenous (AV) fistulas in ESRD patients.
"We are delighted to enroll and treat the first
patient in this significant study of IN.PACT AV Access DCB in
patients with obstructed AV access," said Jeffrey Hull, M.D.,
principal investigator at Richmond Vascular Center in Richmond, Va.
"Maintaining access patency is critical to delivering dialysis
treatment, and for salvaging failing AV fistulas. Durable treatment
options in these patients are limited."
Globally, more than 2.5 million patients with
end-stage renal disease are undergoing dialysis,1 a
procedure that filters waste and removes extra fluid from the blood
when the kidneys are no longer healthy. AV access sites are used to
provide hemodialysis to patients. Over time, thickening of the
vessel walls limits the ability to use a dialysis access site,
requiring repeat interventions to open up the vessels, which
increase health care utilization and reduce quality of care.
Repeated procedures are also associated with high technical failure
rates and reduced quality of life for patients.2,3
"This important clinical study is designed to
address the clinical need for new, innovative options for patients
with limited AV access," said Robert A. Lookstein, M.D., national
principal investigator in the U.S. and professor of radiology and
surgery, vice-chair of interventional services, and medical
director of clinical supply chain at Mt. Sinai Healthcare System.
"DCBs are supported by clinical evidence in patients with
peripheral artery disease (PAD) in the upper leg. We hope that this
study may provide data to support this DCB's use to improve patency
and reduce the need for repeat interventions in AV access sites for
patients on dialysis."
The IDE study will evaluate the safety and
efficacy of the IN.PACT AV Access DCB for up to two years at
approximately 30 sites in the United States, Japan, and New
Zealand. In addition to Dr. Robert Lookstein, global principal
investigators include: Andrew Holden, M.D., director of
interventional radiology at Auckland Hospital and associate
professor of radiology at Auckland University, and Hiroaki
Haruguchi, M.D., clinic director at Haruguchi Vascular Clinic. The
study will aim to enroll 330 patients with a 1:1 randomization to
either treatment with IN.PACT(TM) AV Access DCB or standard PTA.
The primary efficacy endpoint is patency of dialysis fistulas
through six months and the primary safety endpoint is serious
adverse events through 30 days.
"Through our ongoing dialogue with the clinical
community, we recognize that maintaining patency at AV access sites
for dialysis patients is a critical challenge," said Mark Pacyna,
general manager of the Peripheral business, which is part of the
Aortic & Peripheral Vascular division at Medtronic.
"Advancement of this study demonstrates our strong commitment to
addressing challenging lesions and improving patient care in
patients with ESRD."
The IN.PACT AV Access DCB is based on the IN.PACT
Admiral DCB technology. The IN.PACT Admiral DCB is FDA approved to
treat patients with PAD in the upper leg.
IN.PACT AV Access is an Investigational Device and
is not FDA approved for sale in the United States.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
1 European
Renal Care Provider Association. Facts and Figures.
http://ercpa.eu/facts-figures/
2 Maya, I.
D. and M. Allon (2008). "Vascular access: core curriculum 2008." Am
J Kidney Dis 51(4): 702-708.
3 Maya, I. D.,
et al. (2009). "Outcomes of brachiocephalic fistulas, transposed
brachiobasilic fistulas, and upper arm grafts." Clin J Am Soc
Nephrol 4(1): 86-92
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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