Medtronic Drug-Coated Balloon for Treatment of Peripheral Arterial Disease Shows Strong Results in Long Lesions
May 20 2015 - 9:30AM
First Report of
Findings from IN.PACT Global Study's Imaging Cohort Presented at
EuroPCR
PARIS -- May 20, 2015 --
Presented for the first time today at EuroPCR during the "Hot line"
session on "Peripheral interventions," new clinical data from two
different studies show that the IN.PACT Admiral drug-coated balloon
from Medtronic plc (NYSE: MDT) successfully treated long lesions in
the superficial femoral and popliteal arteries.
Prof. Dierk Scheinert, chairman of the division
for interventional angiology at University-Hospital Leipzig in
Germany, presented 12-month results for 157 patients enrolled in
the IN.PACT Global Study's long lesion imaging cohort. The average
lesion length in this subset was 26.4 ± 8.61 cm -- nearly three
times longer than the average lesion length of 8.9 ± 5.07 cm in the
randomized controlled IN.PACT SFA Trial.
The IN.PACT Admiral drug-coated balloon (DCB)
received approval from the U.S. Food and Drug Administration (FDA)
in December 2014 for percutaneous transluminal angioplasty (PTA),
after pre-dilitation, of de novo or restenotic lesions up to 18 cm
in length in native superficial femoral or popliteal arteries with
reference vessel diameters of 4-7 mm. It received the CE (Conformité Européene) mark in 2009 for PTA in patients
with obstructive disease of peripheral arteries -- a broader
indication that does not specify lesion length or reference vessel
diameter.
The 157 patients from the IN.PACT Global Study's
long lesion imaging cohort had a total of 164 lesions of at least
15 cm in length. In addition to long lesion length, they also
featured other challenging characteristics: 71.8 percent had
calcified lesions, 60.4 percent had total occlusions and 41.0
percent had diabetes.
Despite these challenges, treatment with the
IN.PACT Admiral DCB delivered excellent outcomes at 12 months,
including a 6.0 percent rate of clinically-driven target lesion
revascularization (CD-TLR) and primary patency of 91.1 percent
according to Kaplan Meier analysis at 360 days post-procedure.
Prof. Scheinert also highlighted key safety data
in his presentation -- specifically, 94.0 percent freedom from
major adverse safety events and no major target limb amputations
through 12-month follow-up.
"For patients with peripheral arterial disease in
the lower extremities, long lesions pose a notoriously difficult
treatment challenge," explained Prof. Scheinert, who is an
investigator in the IN.PACT Global Study. "That's why the 12-month
results in this long-lesion subset are so impressive. The results
are also remarkably consistent with those from similar studies of
the IN.PACT Admiral drug-coated balloon, irrespective of lesion
length."
The IN.PACT Global Study is the largest and most
rigorous post-market evaluation of any peripheral artery
intervention ever undertaken. It has enrolled more than 1,500
patients at 64 sites worldwide to characterize the performance of
the IN.PACT Admiral DCB in the context of routine clinical
practice.
The IN.PACT Global Study's imaging cohort consists
of three sub-groups, each with at least 150 patients: de novo
in-stent restenosis; long lesions (at least 15 cm); and chronic
total occlusions (at least 5 cm). All patients in the imaging
cohort were required to undergo duplex ultrasound at 12-months
post-procedure and at the time of a reintervention (if one
occurred) to assess for patency.
Outcomes for patients in the in-stent restenosis
and chronic total occlusion subgroups are expected to be presented
at medical meetings over the next 12 months, as are two-year
results from the IN.PACT SFA Trial, including the economic outcomes
analysis.
The other study of the IN.PACT Admiral DCB's
performance in long lesions presented today at EuroPCR, the DEB
SFA-LONG Study, was conducted at six sites in Italy and enrolled
105 patients with an average lesion length of 25.2 cm. The 12-month
results were presented by Dr. Antonio Micari, director of GVM Care
& Research at Maria Cecilia Hospital in Palermo, and were
consistent with those from the long-lesion subset of the IN.PACT
Global Study's imaging cohort.
Using the same definitions, the CD-TLR rate in
this independent, multicenter Italian study was 4.0 percent, and
primary patency was 89.3 percent according to Kaplan Meier analysis
at 360 days post-procedure.
"The latest data on the IN.PACT Admiral
drug-coated balloon adds to the growing body of evidence that
supports the device's use as a treatment for atherosclerotic
lesions in the superficial femoral and popliteal arteries," said
Dr. Mark Turco, medical director of the Aortic and Peripheral
Vascular business at Medtronic. "It's especially encouraging to see
such concordant results across company-sponsored and
physician-initiated studies. We look forward to sharing additional
data from the IN.PACT SFA Trial and IN.PACT Global Study as
follow-up in our robust clinical program continues."
In collaboration with leading clinicians,
researchers and scientists, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular diseases and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
worldwide.
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Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology -- alleviating
pain, restoring health and extending life for millions of people
around the world.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
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anticipated results.
- end -
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