Medtronic Receives IDE Approval to Initiate Study of IN.PACT® Admiral® Drug-Coated Balloon for a New Indication in Patients with End-Stage Renal Disease
(Thomson Reuters ONE) -
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:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 26.01.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 520172
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