Health-Economic
Analysis Demonstrates Medtronic IN.PACT Admiral Drug-Coated Balloon
Is Cost-Effective Compared to Standard PTA; Global Study Data
Demonstrates Strong Clinical Outcomes in Patients with In-Stent
Restenosis
DUBLIN and LAS VEGAS - Nov. 2,
2015 - Medtronic plc (NYSE: MDT) adds to the robust data for
its IN.PACT® Admiral® drug-coated balloon (DCB) with the
presentation of both its formal cost-effectiveness analysis from
the U.S. cohort of the IN.PACT SFA Trial and clinical results from
the in-stent restenosis cohort data from Medtronic's IN.PACT Global
Study. The data were announced during a special late-breaking
clinical trials session at VIVA 2015.
David Cohen, M.D., M Sc, of Saint Luke's Mid
America Heart Institute in Kansas City, Mo., presented the
health-economic analysis, demonstrating that IN.PACT Admiral DCB is
cost effective in comparison to standard percutaneous transluminal
angioplasty (PTA) for the treatment of femoropopliteal artery
lesions. Marianne Brodmann, M.D. of Medical University, Graz,
Austria, presented real world data from Medtronic's global study
for IN.PACT Admiral DCB, where one-year in-stent restenosis (ISR)
data showed safety and effectiveness in treating complex ISR
lesions.
Health-Economic Analysis
Establishes Superiority of Medtronic DCB Over PTA
The prospective, two-year cost-effectiveness study
of the IN.PACT Admiral DCB, carried out in conjunction with the
IN.PACT SFA Trial in the U.S., demonstrated that IN.PACT Admiral
DCB is more than cost-effective, but actually is an "economically
dominant"1 strategy in
treating SFA disease compared to PTA. Cost-effective strategies
generally justify higher costs for improved clinical efficacy,
whereas economically dominant therapies provide higher
clinical efficacy and lower costs. The pivotal IN.PACT SFA Trial
was designed to test the safety and efficacy of IN.PACT Admiral DCB
versus standard PTA in patients with superficial femoral artery
(SFA) disease (NCT01566461); two-year clinical data were recently
published in the Journal of the American College
of Cardiology (JACC). The IN.PACT SFA Trial included a
prospectively designed economic analysis in order to provide
healthcare decision makers with further insight into the economic
effectiveness of IN.PACT Admiral DCB.
"While the index hospitalization costs were
approximately $1,100 per patient higher in patients treated with
DCB compared to standard PTA, over the two year follow up period,
treatment costs were approximately $1,200 per patient less with DCB
than standard PTA," said Dr. Cohen. "This net economic advantage
for IN.PACT Admiral DCB was driven primarily by the significant
reduction in target limb revascularization procedures with DCB over
two years of follow up."
Overall, the DCB index hospitalization costs were
higher compared to PTA ($8,293 vs $7,164, respectively (p=0.03))
but this initial higher cost was offset by a substantial reduction
in follow-up costs through two years ($2,984 vs $4,196,
respectively (p=0.52)). This led to lower total costs in the DCB
arm by the end of two years on top of the significantly lower
number of revascularizations in the DCB arm. The follow-up
costs included items such as medications, physician fees,
outpatient vascular care and repeat hospitalizations.
The economic sub-study analysis was carried out
from the perspective of the U.S. healthcare system and included 181
U.S. patients in the IN.PACT SFA Trial. The analysis prospectively
measured patients' quality of life using the EQ-5D(TM), and
assessed the total PAD-related healthcare costs (target limb only)
to assess the incremental cost-effectiveness of DCB versus standard
PTA in terms of the two year cost per quality-adjusted life-year
gained. The study, which was sponsored by Medtronic, was conducted
independently by the Mid America Heart Institute's (MAHI) Health
Economics and Technology Assessment (HETA) Group.
In addition to the base case analysis which found
DCB to be economically dominant, a probabilistic sensitivity
analysis (PSA) to assess uncertainty of the results demonstrated
that IN.PACT Admiral DCB has a high probability of being
economically attractive (ICER<$50,000 QALY) compared to standard
PTA, thereby increasing confidence in the robustness of the
analysis.
The results from this economic analysis support
the positive reimbursement decisions that many healthcare payers
around the world have made who are covering this therapy for their
populations. In the U.S., for example, the superior effectiveness
of IN.PACT Admiral DCB was recognized by the U.S. Centers for
Medicare and Medicaid Services (CMS) with the approval, earlier
this year, of both hospital outpatient and inpatient new
technology add-on payments to support access to DCB therapy.
One-Year Outcomes from the
IN.PACT Global Study Demonstrate Effectiveness in Complex ISR
Lesions in the SFA
The one-year data from the real world IN.PACT
Global Study demonstrating the effectiveness of IN.PACT Admiral DCB
in the treatment of challenging ISR lesions were presented today.*
This cohort from the prospective, multicenter, single-arm study
with independent core laboratory and clinical events committee
adjudication included 131 patients with pure de
novo ISR lesions.
Complex lesion types, including long lesions,
chronic total occlusions and ISR, remain challenging to treat with
no identified current treatment standards. ISR is estimated to
occur in 30 to 40 percent of all stents placed in the SFA.
Treatment with standard PTA techniques is associated with poor
patency outcomes.
The one-year primary patency rate for this
difficult to treat patient subgroup was 88.7 percent, and the
CD-TLR rate was a low 7.3 percent, especially considering the mean
lesion length of 17.2 + 10.5 cm.
"Results demonstrate effectiveness and safety of
the IN.PACT Admiral DCB in the treatment of patients with complex
SFA lesions, including challenging ISR lesions," said Dr. Brodmann.
"The primary patency is unmatched in this difficult to treat
patient subgroup."
"IN.PACT Admiral DCB is a proven primary therapy
for SFA disease. The latest clinical results demonstrating
consistency, safety, efficacy and cost-effectiveness will continue
to drive a paradigm shift in SFA interventions," said Brian
Verrier, vice president and general manager of the Peripheral
franchise, within the Aortic and Peripheral Vascular business at
Medtronic. "Another key pillar of Medtronic's mission is the
ongoing pursuit of providing solutions which increase economic
value within the healthcare system. We are proud to showcase our
commitment to improving outcomes and increasing economic value
through IN.PACT Admiral DCB."
Medtronic will host symposia to provide further
analysis and discussion on DCB treatment in the SFA and the impact
on patient outcomes at VIVA 2015 this week.
- IN.PACT SFA Trial 2-Year
Outcomes: How Will this Evidence Shift the PAD Treatment
Paradigm. Speakers: John Laird, M.D., David Cohen, M.D., M Sc,
and Renu Virmani, M.D. Monday 12-1:15PM
- Advancing Treatment in Complex
Lesions: Gain the Edge with Clinical Evidence. Speakers:
Prakash Krishnan, M.D., Marianne Brodmann, M.D., Antonio Micari,
M.D., Eric Scott, M.D. Tuesday 12-1:15PM
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 IN.PACT Admiral Drug-Coated
Balloon
IN.PACT Admiral drug-coated balloon (DCB) is designed to reopen
superficial femoral and popliteal arteries that have been narrowed
or blocked by plaque. Once deployed in the artery, the balloon
delivers a proven, safe and effective dose of the anti-restenotic
drug paclitaxel to the artery walls. The drug aims to prevent the
artery from narrowing again by minimizing scar tissue
formation.
IN.PACT Admiral DCB received the CE (Conformité
Européene) mark in 2009 and approval by the U.S. Food & Drug
Administration in December 2014. It is the most studied drug-coated
balloon to-date. Medtronic is conducting four Medtronic-sponsored
studies, which include IN.PACT SFA, IN.PACT Global, IN.PACT Japan
and IN.PACT China, to assess the safety and effectiveness of the
IN.PACT Admiral DCB. In addition, Medtronic is supporting
approximately 20 physician-initiated DCB studies. In total, data on
more than 4,000 patients treated with the IN.PACT Admiral DCB will
be available.
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 85,000 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.
*
IN.PACT® Admiral® drug-coated balloon (DCB) is not
indicated for ISR use in the U.S.
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 From
Interpreting the Results of Cost-Effectiveness
Analysis, J Am Coll Cardiol. 2008;52(25):2119-2126.
doi:10.1016/j.jacc.2008.09.018
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#1963342
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024