Medtronic Receives FDA Approval of First Drug-Coated Balloon for Treatment of In-Stent Restenosis (ISR)
September 13 2016 - 11:00AM
IN.PACT Admiral
DCB Indication Expansion to Treat Patients with ISR
DUBLIN - Sept. 13, 2016 -
Medtronic plc (NYSE: MDT) today announced that the U.S. Food and
Drug Administration (FDA) approved the IN.PACT(TM) Admiral(TM)
drug-coated balloon (DCB) as a treatment for in-stent restenosis
(ISR) in patients with peripheral artery disease (PAD). This is the
first DCB that has gained approval to treat ISR in the U.S. FDA
approval was based on ISR data from the IN.PACT Global Study
compared to a standard percutaneous balloon angioplasty (PTA)
control.
"We are experiencing a paradigm shift in treating
patients with complex PAD," said John Laird, M.D., interventional
cardiologist at U.C. Davis Medical Center and co-principal
investigator for the IN.PACT SFA Trial. "Until now physicians have
had limited treatment options to address patients with ISR. The
FDA's approval of IN.PACT Admiral DCB allows us to treat patients
with a durable, proven, and safe technology."
ISR occurs when a stent is placed in the artery to
restore blood flow but over time plaque can form in and around the
stent. This condition is estimated to occur in up to 40 percent of
all stents placed in the superficial femoral artery
(SFA).1,2
"Prior to the FDA approval of IN.PACT
Admiral DCB for ISR, physicians were challenged to find a durable
treatment for PAD patients, considering the complexity of the
disease," said Mark Pacyna, vice president and general manager of
the Peripheral business, which is part of the Aortic &
Peripheral Vascular division at Medtronic. "Together, in
collaboration with physicians in the vascular clinical community,
we designed the IN.PACT Global Study to look at challenging lesions
in real-world patients. Today, the IN.PACT Admiral DCB has
demonstrated consistent outcomes across all patient morphologies,
and it is the only DCB approved to treat patients with ISR in
the U.S."
Real-world data from the IN.PACT Global Study
demonstrating safe and effective treatment of complex ISR lesions
was first presented on the scientific podium at VIVA 2015. The
one-year primary patency rate for this difficult to treat patient
subgroup in the IN.PACT Global ISR Imaging Cohort was 88.7 percent,
and the clinically-driven target revascularization (CD-TLR) rate
was 7.3 percent. The mean length of lesions was 17.2 ± 10.5 cm,
with 34.0 percent occluded ISR lesions. Additional ISR data from
the IN.PACT Global Study and a PTA control were used to gain FDA
approval of the ISR indication.
About IN.PACT Admiral Drug-Coated
Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven,
cost-effective primary endovascular therapy that enables physicians
to treat claudication and restenosis for patients with superficial
femoral artery (SFA) disease. The DCB's primary mode of action is
physical dilatation of the vessel lumen by PTA, and the proven
paclitaxel drug is intended to prevent artery narrowing by
minimizing scar tissue formation.
IN.PACT Admiral DCB received the CE (Conformité
Européene) Mark in 2009 to treat PAD and was approved by the U.S.
Food & Drug Administration in December 2014 to treat
superficial femoral and popliteal arteries. It has been studied in
more than 20 individual clinical trials demonstrating durable
safety and clinical benefits. To date, more than 150,000 patients
have been treated with IN.PACT Admiral DCB.
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 disease and
cardiac arrhythmias. The company strives to offer products and
services of the highest quality that deliver clinical and economic
value to healthcare consumers and providers around the world.
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 Laird,
J.R., et al., Nitinol stent implantation versus
balloon angioplasty for lesions in the superficial femoral artery
and proximal popliteal artery: twelve-month results from the
RESILIENT randomized trial. Circ Cardiovasc Interv, 2010.
3(3): p. 267-76.
2 Armstrong,
E.J., et al., Nitinol self-expanding stents vs.
balloon angioplasty for very long femoropopliteal lesions. J Endovasc Ther, 2014.
21(1): p. 34-43.
Contacts:
Krystin Hayward
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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