Medtronic Drug-Coated Balloon Receives U.S. FDA Approval to Treat Arteriovenous Fistula Lesions
November 21 2019 - 11:05AM
Medtronic plc (NYSE:MDT) today announced U.S. Food and Drug
Administration (FDA) approval of the IN.PACT™ AV drug-coated
balloon (DCB), a paclitaxel-coated balloon indicated for the
treatment of failing arteriovenous (AV) access in patients with
end-stage renal disease (ESRD) undergoing dialysis.
AV fistulae are created and used to enable
hemodialysis for patients with ESRD. Over time, vessel restenosis
limits the ability to use AV fistulae effectively. In order to
restore function, patients often undergo one to three maintenance
procedures per year,1 which can result in significant
disruptions to critical hemodialysis care and increased costs to
the healthcare system. Pivotal randomized trial results from the
IN.PACT AV Access trial have shown IN.PACT AV DCB can extend the
time between reinterventions by maintaining AV access site patency,
therefore maximizing a patient’s uninterrupted access to
lifesaving dialysis care.
“In many cases, AV fistula are considered
lifelines for patients with ESRD as they are the primary access
point for life-saving dialysis treatment. When these access sites
fail, patients experience delays in their dialysis treatment and
require multiple reinterventions to keep the site functioning,”
said Vincent Gallo, M.D., interventional radiologist at Holy Name
Medical Center in Teaneck, New Jersey and an investigator for the
IN.PACT AV Access trial. “With this approval physicians now have
access to a safe and extremely effective therapy to slow the
progression of restenosis, which results in fewer reinterventions
and disruptions in care for these patients.”
The FDA approval is based on data from a
prospective, global, multicenter, blinded, randomized (1:1),
investigational device exemption (IDE) study, which enrolled 330
subjects, and evaluated the safety and effectiveness of the IN.PACT
AV DCB at 29 sites in the United States, Japan, and New Zealand.
Early data presented at the Cardiovascular Interventional
Radiological Society of Europe (CIRSE) met the primary endpoints in
demonstrating the comparable safety and the superior effectiveness
of IN.PACT AV DCB compared to percutaneous transluminal angioplasty
(PTA). Patients treated with IN.PACT AV DCB maintained patency
longer and required 56% fewer reinterventions compared to those
treated with standard PTA through six months. Through 12 months the
data also showed no difference in mortality rates between the
IN.PACT AV DCB group and the PTA control group. Finally, data
presented at VIVA 2019 demonstrated superior patency was achieved
with IN.PACT AV DCB versus PTA in both de novo and restenotic
lesions, and all studied types of AV access.
“Until now, there were virtually no therapies
available to treat AV fistulae lesions that had demonstrated an
ability to maintain primary patency and reduce reinterventions over
time,” said Robert 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 in New York, New York. “In the
largest AV DCB pivotal study to-date, IN.PACT AV DCB demonstrated
the highest primary patency rate through six months and
significantly lowered the rate of reinterventions required to
maintain patency. With this evidence and approval in hand, we now
have a technology that provides a significant clinical benefit of a
56% reduction in repeat interventions, which I believe is a huge
win for the hemodialysis community and the patients we treat.”
IN.PACT AV DCB, leveraging technology from
Medtronic’s IN.PACT™ Admiral™ platform, increases blood flow and
reduces thickening of the vessel wall by delivering the proven
anti-proliferative drug paclitaxel. This drug penetrates deep into
the vessel wall to prevent restenosis and has the potential to
extend time between reinterventions. In 2016, the CE Mark
indication for IN.PACT Admiral DCB was expanded for the treatment
of failing arteriovenous (AV) access in patients with end-stage
renal disease undergoing dialysis.
“The FDA approval of IN.PACT AV DCB marks a
significant step forward for paclitaxel-coated devices.
Importantly, it allows us to expand our proven IN.PACT DCB platform
beyond the superficial femoral artery,” said Mark Pacyna, vice
president and general manager of the Peripheral Vascular business
in the Medtronic Cardiac & Vascular Group. “We are excited to
bring this technology to physicians in the U.S. and to help improve
the lives of patients living with ESRD.”
In collaboration with leading clinicians,
researchers, and scientists worldwide, Medtronic offers the
broadest range of innovative medical technology for the
interventional and surgical treatment of cardiovascular and
end-stage renal disease. The company strives to offer products and
services that deliver clinical and economic value to healthcare
consumers and providers around the world.
About MedtronicMedtronic
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 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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-
1THE USRDS Special Study Center. Transition of
care in CKD. Prelude to Dialysis: Trends and Timely Transitions.
Kalantar-Zadeh K. Et Al. 2016
Julia FullerPublic Relations+1-707-210-2069
Ryan WeispfenningInvestor Relations+1-763-505-4626
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