Feasibility Study of Medtronic Drug-Coated Balloon Technology
for Challenging Below-the-Knee Disease Shows Promise in Patients
with Critical Limb Ischemia
DUBLIN, Oct. 18, 2020 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
announced the first-ever results from the IN.PACT BTK Study, a
feasibility study assessing the safety and effectiveness of the
IN.PACT 0.014 drug-coated balloon (DCB) in critical limb ischemia
(CLI) subjects with chronic total occlusion (CTO) in the
infrapopliteal arteries. The data were presented in the
Late-Breaking Clinical Trial Sessions at TCT Connect, the
32nd annual scientific symposium of the
Cardiovascular Research Foundation.
"The design of this feasibility study is incredibly thorough,
and required rigorous procedural, duplex ultrasound, and
angiographic protocols to more accurately evaluate these complex
lesions," said Antonio Micari, M.D.,
Department of Invasive Cardiology, University of Messina, Messina,
Italy. "Despite enrolling subjects with challenging lesions
commonly seen in BTK disease, including those with CTOs, long
lesions, and severe calcification, the results of the study are
promising."
The IN.PACT BTK study is a prospective, multi-center, 1:1,
randomized feasibility study assessing the safety and effectiveness
of the IN.PACT 0.014 DCB, a 3.5 μg/mm2
dose paclitaxel-coated balloon, versus conventional
percutaneous transluminal angioplasty (PTA) for the treatment of
CTOs in the infrapopliteal arteries. The study enrolled 50 subjects
at nine sites in Europe.
The effectiveness endpoint evaluated nine-month late lumen loss,
an angiographic measurement comparing the post-procedure lumen
diameter with the lumen diameter at nine months, specifically
sub-segmental late lumen loss, or lumen loss assessed along the
entirety of the lesion; and classic late lumen loss, or lumen loss
measured at the single narrowest segment of the artery. The safety
endpoint evaluated a composite of freedom from device- and
procedure-related mortality within 30 days, freedom from major
target limb amputation within nine months, and freedom from
clinically driven target limb revascularization (CD-TLR) within
nine months post-index procedure.
At nine months, subjects in the DCB group experienced a
reduction in sub-segmental late lumen loss compared to those in the
PTA control group (0.59mm +/-0.94mm versus 1.26mm +/- 0.81mm
respectively, p=0.017), a 53% lower late lumen loss than the PTA
control group. Using the classic late lumen loss method, subjects
in the DCB group experienced lower late lumen loss compared to
those in the PTA control group at nine months (0.89mm +/- 0.77mm
versus 1.31mm +/- 0.72mm respectively, p=0.07 ), a 32% lower late
lumen loss than the PTA control group.
There was no statistical difference in the safety composite
endpoint within nine months between the DCB group and PTA control
group (91.3% versus 87.5% respectively; p=1.000). Safety outcomes
by category included a freedom-from:
- Device and procedure-related death through 30 days: 0.0% in the
DCB group compared to 3.7% in the PTA control group (p=1.000)
- Target limb Major amputation within 270 days: 0.0% in the DCB
group compared to 0.0% in the PTA control group (p>0.999)
- CD-TLR within 270 days: 8.7% in the DCB group compared to 8.7%
in the PTA control group (p=1.000)
"As a result of our learnings from the earlier IN.PACT DEEP
study, we now have a better understanding of this challenging
vessel bed, as well as deep expertise in BTK clinical trial and
product design," said Simona
Zannetti, M.D., vice president, Clinical Research, Medical
Affairs, and Education, Medtronic Aortic, Peripheral, and Venous.
"Unlike in the coronaries, patients with BTK disease have very long
lesions. By evaluating late lumen loss at the sub-segmental level,
we are better able to understand paclitaxel drug effect across the
entire lesion."
Historically, there has not been a DCB technology that has
demonstrated effectiveness in this vessel bed. The data presented
today demonstrate that IN.PACT 0.014 may offer a clinical benefit
in patients with CLI. Previously, Medtronic conducted the IN.PACT
DEEP study, which evaluated the safety and effectiveness of the
previous generation IN.PACT™ Amphirion DCB, and has published
data out to five-years. That study did not meet its effectiveness
endpoint, which resulted in the decision to remove IN.PACT
Amphirion DCB from the market in 2013. Notably, the IN.PACT 0.014
DCB, utilized in the current IN.PACT BTK study, uses the same
DCB formulation that has demonstrated effectiveness in the
IN.PACT™ Admiral and IN.PACT™ AV DCB clinical
programs.
"Today's milestone is the result of a close partnership between
Medtronic and the clinical community to design a thoughtful BTK
study to assess how the IN.PACT 0.014 DCB works on some of the most
challenging lesions in critically ill patients with BTK disease,"
said Mark Pacyna, vice president and
general manager of the Peripheral Vascular business, which is part
of the Cardiac and Vascular Group at Medtronic. "We are encouraged
by the results of this feasibility study and are committed to
investing in further BTK studies to serve this critical patient
need."
The IN.PACT 0.014 DCB is an investigational device that is being
evaluated in Europe. This device
is not currently being evaluated in the
United States.
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 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 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
health care 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.
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SOURCE Medtronic plc