Clinical Evidence
Shared at TCT and CIRSE Reaffirm IN.PACT(TM) Admiral(TM)
Drug-Coated Balloon as a Primary Therapy to Treat Complex,
Real-World Patient Populations
SAN DIEGO and LISBON, Portugal - September 22,
2018 - Medtronic plc (NYSE:MDT) data
announced today continue to reinforce the safety, durability, and
consistency of the IN.PACT(TM) Admiral(TM) drug-coated balloon
(DCB) in real-world patients with peripheral arterial disease
(PAD). Three-year real-world results from the full clinical cohort
of the IN.PACT Global Study and one-year data from the Total
IN.PACT(TM) pooled imaging and propensity analyses were presented
at the Cardiovascular and Interventional Radiological Society of
Europe (CIRSE) annual meeting and the 30th
Transcatheter Cardiovascular Therapeutics (TCT) conference, the
annual scientific symposium of the Cardiovascular Research
Foundation, respectively.
"The two datasets presented today at TCT and CIRSE
are testaments to the breadth and depth of our IN.PACT Admiral
clinical program. We are committed to providing the clinical
community with timely and transparent access to data to better
inform their treatment decisions," said Mark Pacyna, vice president
and general manager of the Peripheral business, which is part of
the Aortic, Peripheral, and Venous division at Medtronic.
"Consistently across trials, IN.PACT Admiral has demonstrated its
ability to treat varying PAD patient populations, while effectively
preserving future treatment options."
IN.PACT Global Study: Three-Year
Results Show Durability of Treatment Effect in Real-World
Population
Professor Gunnar Tepe, M.D., director of Diagnostic and
Interventional Radiology at the Academic Hospital RoMed Clinic in
Rosenheim, Germany, presented the new, three-year results from the
full clinical cohort of the IN.PACT Global Study. The results are
the first three-year, real-world, fully adjudicated DCB data to be
presented in a scientific congress and showed durability of
treatment effect in a real-world population.
The freedom from clinically-driven target lesion
revascularization (CD-TLR) rate calculated using Kaplan Meier
survival estimates was 76.9 percent in a real-world patient cohort
with a mean lesion length of 12.09 ± 9.54 cm, 18.0 percent in-stent
restenosis, 35.5 percent occluded lesions, and 39.9 percent
diabetic subjects. Additionally, the proportion of patients
undergoing repeat procedures were low through three years:
major target limb amputations, 0.8 percent, and CD-TLR, 23.5
percent (n=1,406).
"Superficial femoral artery (SFA) disease is
becoming more prevalent globally and is often difficult to treat
due to its complex nature. Now more than ever, it is important to
carefully assess how therapies to treat this condition perform over
the long-term among real-world patients," said Prof. Tepe. "IN.PACT
Global was designed with this goal in mind and has now demonstrated
the durability, efficacy, and safety of IN.PACT Admiral in complex
lesions out to three years - something few SFA studies have been
able to achieve thus far."
The IN.PACT Global Study is the largest and most
rigorous real-world evaluation of any peripheral artery
intervention ever undertaken and intends to characterize the
performance of the IN.PACT Admiral DCB in treating real-world
patients with challenging and complex lesions. The study included
adjudication of events by an independent clinical events
committee.
Total IN.PACT(TM) Pooled Imaging
and Propensity Analyses: Delta in Patency Rates Demonstrates DCB's
Persistent Superiority to Standard Percutaneous Transluminal
Angioplasty (PTA)
Dr. Mehdi Shishehbor, D.O., M.P.H., Ph.D., director of the Heart
and Vascular Institute, University Hospitals Cleveland Medical
Center, presented one-year overall imaging and propensity-matched
imaging data from the Total IN.PACT Pooled Analysis at TCT. The
Total IN.PACT Pooled Analysis is an undertaking by Medtronic to
enhance the understanding of PAD patient treatment algorithms by
characterizing the clinical performance of IN.PACT Admiral in the
largest and most diverse study population treated with DCBs to
date.
Total IN.PACT combined independently adjudicated
data from a total of 1,837 patients treated with IN.PACT Admiral
DCB from all IN.PACT Admiral randomized clinical trials and
real-world studies from 147 sites across 28 countries. The analyses
presented today at TCT specifically looked at two different groups
- a core laboratory-adjudicated imaging cohort and a propensity
matched imaging cohort. The data showed that IN.PACT Admiral DCB
demonstrated consistently superior patency and freedom from
clinically-driven target lesion revascularization (CD-TLR) compared
to standard PTA alone.
The imaging cohort, which evaluated 926 DCB and
143 PTA subjects, demonstrated a patency rate of 88.8 percent for
IN.PACT Admiral compared to 53.9 percent for PTA (p<0.001) and a
freedom from clinically-driven target lesion revascularization
(CD-TLR) rate of 94.3 percent compared to 80.2 percent for PTA
(p<0.001). Additional safety and effectiveness outcomes from the
DCB arm also included low rates of thrombosis (2.4 percent), and
CD-TLR (5.8 percent), and no occurrences of major target limb
amputation at one year.
The propensity analysis (a subset of the imaging
cohort) matched one PTA subject with up to four IN.PACT Admiral DCB
subjects based on baseline variables (136 PTA subjects and 466 DCB
subjects). The propensity-matched analysis showed a patency rate of
90.5 percent for the IN.PACT Admiral DCB as compared to 53.8
percent for PTA (p<0.001) and a freedom from CD-TLR rate of 96.9
percent compared to 80.7 percent for PTA (p<0.001). Additional
safety and effectiveness outcomes from the DCB arm also included
low rates of thrombosis (1.6 percent) and CD-TLR (3.3 percent), and
no occurrences of major target limb amputation at one year.
"By pooling data from multiple IN.PACT study
cohorts, we are able to glean valuable insights into clinical
outcomes across a broad spectrum of patient and lesion types beyond
the reach of typical cohort DCB analyses," said Dr. Shishehbor.
"Despite having more advanced lesions, the Total IN.PACT data
presented today at TCT further confirm the consistent performance
we've seen across IN.PACT studies by showing approximately 35
percent superior patency with DCB compared to PTA in the imaging
cohort and approximately 37 percent superior patency with DCB
compared to PTA in the propensity-matched cohort at one year. This
calls into question the use of primary PTA therapy in an era of
drug eluting technologies like IN.PACT Admiral."
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 86,000 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-
Contacts:
Julia Baron
Public Relations
+1-858-692-2001
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by West Corporation on behalf of West
Corporation 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
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