Medtronic Receives IDE Approval to Initiate Study of IN.PACT® Admiral® Drug-Coated Balloon for a New Indication in Patients...
January 26 2017 - 7:00AM
DUBLIN - Jan. 26, 2017 -
Medtronic plc (NYSE: MDT) today announced receipt of an
investigational device exemption (IDE) from the U.S. Food and Drug
Administration (FDA) to initiate a study of the IN.PACT® Admiral®
drug-coated balloon (DCB) for a potential new indication in
patients with end-stage renal disease. The randomized study will
evaluate the IN.PACT Admiral DCB as a treatment for failing
arteriovenous (AV) fistulas in these patients as compared to plain
balloon angioplasty. The IDE approval enables Medtronic to initiate
the study and gain safety and effectiveness data for the device in
this investigational indication.
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, 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
"In the past, when the AV access site became
narrowed, the only option was use of a standard percutaneous
transluminal angioplasty (PTA) balloon to re-open and regain access
for dialysis. This would often result in restenosis and high rates
of reintervention," said Andrew Holden, M.D., director of
interventional radiology at Auckland Hospital and associate
professor of radiology at Auckland University. "Patients on
dialysis need alternatives to help reduce and manage stenoses of
their AV access sites. It is important to effectively evaluate
options such as this DCB, which already has clinical evidence in
patients with peripheral artery disease (PAD) in the upper leg.
"
The IDE study will evaluate the safety and
efficacy of the IN.PACT DCB for up to two years at approximately 30
sites in United States, Japan, and New Zealand. Principal
Investigators include: Dr. Holden, Robert Lookstein, M.D.,
professor of radiology and surgery, vice-chair of interventional
services, and medical director of clinical supply chain at Mt.
Sinai Healthcare System, and Hiroaki Haruguchi, M.D., clinic
director at Haruguchi Vascular Clinic. The study will aim to enroll
330 patients with a 2:1 randomization to either treatment with
IN.PACT Admiral DCB or standard balloon angioplasty. The primary
efficacy endpoint is patency of dialysis fistulas through six
months and the primary safety endpoint is major adverse events
through 30 days. Additional endpoints include reducing access
circuit related events including repeat procedures.
"IN.PACT Admiral DCB has demonstrated superior
clinical outcomes in patients with PAD in the upper leg. Through
our IN.PACT clinical program, we are looking at ways this DCB
technology can address challenging lesions, and we have
specifically designed the DCB with extended sizes for use in AV
access," said Mark Pacyna, general manager of the Peripheral
business, which is part of the Aortic & Peripheral Vascular
division at Medtronic. "Following receipt of the CE Mark for this
indication last year, the IDE approval and study initiation
reflects our commitment to innovation and, most importantly, to our
patients. This is an exciting new opportunity for our unique DCB
with the potential to reduce rates of repeat procedures, while
improving patient quality of life and quality of care in the
healthcare system."
About IN.PACT Admiral Drug-Coated
Balloon
IN.PACT Admiral DCB received the CE (Conformité
Européene) Mark in 2016 for AV access and in 2009 to treat PAD.
It was approved by the U.S. FDA in December 2014 for percutaneous
transluminal angioplasty, after appropriate vessel preparation, of
restenotic lesions with lengths up to 180 mm in superficial femoral
or popliteal arteries with diameters of 4-7 mm. It is also the only
DCB technology with FDA approval to treat in-stent restenosis
(ISR). IN.PACT Admiral has been studied in more than 20 individual
clinical trials demonstrating durable safety and clinical benefits
in the superficial femoral artery (SFA). It is the only DCB to have
published two year data from a pivotal randomized trial
and also the first to have presented three year data. To
date, more than 200,000 patients have been treated with IN.PACT
Admiral DCB.
The use of IN.PACT Admiral DCB as a treatment for
patients with end-stage renal disease is investigational use only
in the U.S.
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:
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Public Relations
+1-508-261-6512
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Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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