Medtronic IN.PACT Admiral Drug-Coated Balloon Demonstrates Consistent Results in Asia and Belgium According to New Data Presented at LINC 2017
(Thomson Reuters ONE) -
First Presentation of Results from Regional Cohorts of IN.PACT Global Study
Reinforce Strong, Consistent and Safe Outcomes for PAD Patients
DUBLIN and LEIPZIG, Germany - Jan. 25, 2017 - Medtronic today presented new data
at the Leipzig Interventional Course (LINC) 2017 conference supporting the
IN.PACT® Admiral® drug-coated balloon (DCB) in patients with peripheral arterial
disease (PAD). The real-world outcomes from regional cohorts of the IN.PACT
Global Study in Asia and Belgium reinforce the strong efficacy and consistent
outcomes of the IN.PACT Admiral DCB across multiple patient populations.
IN.PACT Global Study: Asian Subset
Donghoon Choi, M.D., from the division of cardiology at Severance Cardiovascular
Hospital in South Korea presented one-year results from the Asian subset of the
IN.PACT Global Study, including data from 114 patients at six sites in South
Korea and Singapore. The results continue to underscore the positive performance
in both safety and efficacy for the IN.PACT Admiral DCB in a broader set of
complex patients with PAD.
In this subset analysis, the low clinically-driven target lesion
revascularization (CD-TLR) at one year (3.8 percent) was consistent with the
results in the complete cohort of 1,406 patients in the IN.PACT Global Study
(7.5 percent). Results of the primary safety endpoint in the Asian cohort were
also consistent with results from the full Global Study cohort, with 96.2
percent of patients achieving positive outcomes.
IN.PACT Global Study: Belgium
In a separate presentation of results from the IN.PACT Global Study, Koen
Deloose, M.D., from the vascular surgery unit at AZ Sint Blasius, presented data
on 305 patients from seven sites in Belgium. Belgium was the first country to
enroll patients in the study and represents the largest enrolling country. At
one year, patients experienced positive outcomes based on both efficacy and
safety measures, consistent with overall findings from the IN.PACT Global Study.
In this patient subset, the low CD-TLR at one year (7.6 percent) was also
consistent with the results in the complete cohort of patients in the IN.PACT
Global Study (7.5 percent). Results of the primary safety endpoint in the
Belgium cohort were also consistent with results from the full study, with 90.6
percent of patients achieving positive outcomes.
"The results from these two patient cohorts in Asia and Belgium support the
unparalleled clinical evidence demonstrating the consistency, durability, and
safety of the IN.PACT Admiral DCB," said Mark Pacyna, general manager of the
Peripheral business, which is part of the Aortic & Peripheral Vascular division
at Medtronic. "We continue to invest in the IN.PACT clinical program to provide
clinicians the broadest possible set of outcomes and measures of clinical rigor
among multiple patient populations. We are pleased to present these data and
further the body of clinical evidence supporting IN.PACT Admiral as a frontline
treatment option globally."
About IN.PACT Global Study
The IN.PACT Global Study is the largest and most rigorous post-market evaluation
of any peripheral artery intervention ever undertaken. It has enrolled over
1,500 patients across 27 countries, including the 1,406 patients in the full
clinical cohort, to characterize the performance of the IN.PACT Admiral DCB in
treating real-world patients with challenging and complex lesions. The study
included external monitoring and adjudication of events by an independent
clinical events committee. Additionally, it included independent core lab
evaluations for pre-specified imaging subsets for subjects with long lesions
(>=15 cm) (n=157), chronic total occlusions (CTO) (>= 5 cm) (n=126) and in-stent
restenosis (ISR) lesions (n=131), as recently presented at international
conferences.
About IN.PACT Admiral Drug-Coated Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven endovascular
therapy indicated for percutaneous transluminal angioplasty, after appropriate
vessel preparation, of restenotic lesions with lengths up to 180 mm in
superficial femoral or popliteal arteries with diameters of 4-7 mm.
To date, more than 200,000 patients have been treated with IN.PACT Admiral DCB.
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-
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions 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
Unternehmensinformation / Kurzprofil:
Datum: 25.01.2017 - 13:00 Uhr
Sprache: Deutsch
News-ID 519883
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