REALITY Study to Evaluate Use of Directional Atherectomy and Drug Coated Balloon in Patients with Peripheral Arterial Disease
November 02 2015 - 1:30PM
VIVA Physician
Sponsored Study to Determine the Benefits of Debulking Plaque and
Maximizing Luminal Gain Prior to Drug Coated Balloon
Therapy
DUBLIN and LAS VEGAS - Nov. 2,
2015 - Medtronic plc (NYSE: MDT) announced today the initiation
of the REALITY Study (DiRectional AthErectomy + Drug-coAted BaLloon
to Treat Long, Calcified FemoropopliTeal ArterY Stenoses) to
evaluate patient outcomes following adjunctive use of directional
atherectomy and drug-coated balloon (DCB) treatment of patients
with symptomatic peripheral arterial disease (PAD) in long,
calcified lesions in the superficial femoral artery (SFA) and/or
popliteal artery. The study is sponsored and will be managed by
VIVA Physicians, and will have multidisciplinary representation in
leadership.
The REALITY Study is a multi-center, prospective,
single-arm observational angiographic and duplex ultrasound core
lab adjudicated study that will enroll 250 subjects at up to 20
sites across the U.S. with primary patency assessed by duplex
ultrasound at 12-months. Patients will be followed to 24 months to
determine CD-TLR. Medtronic's directional atherectomy systems and
IN.PACT®
Admiral® drug-coated
balloon will be studied in REALITY. The study also includes several
important core lab adjudicated sub-analyses including the
intravascular ultrasound assessment of the efficiency of
directional atherectomy to debulk various plaque morphologies
including severe calcium in long lesions prior to DCB deployment
and the validation of the Peripheral Arterial Calcium Scoring Scale
(PACSS) to assess the impact of severe vessel calcification on
Major Adverse Clinical Events (MACE) from the procedure through 12
months. Importantly, a health economics and Quality of Life
assessment will also be included as part of REALITY.
"As standalone treatments for peripheral arterial
disease, directional atherectomy and DCBs have demonstrated strong
clinical results. However, challenges in treating long and severely
calcified femoropopliteal lesions remain including the associated
provisional stent rate with DCB and reintervention rates with
directional atherectomy over the long-term," said Dr. Krishna
Rocha-Singh, chief scientific officer, Prairie Heart Institute at
St. John's Hospital; Springfield, Ill. "The REALITY study was
driven by the need to look at a viable treatment paradigm that
combines the use of directional atherectomy and DCB therapy to
address these challenges."
At VIVA 2014, Covidien (now Medtronic) presented
the one-year results from the DEFINITIVE AR pilot study, which
showed early promise in calcified and long lesions for PAD patients
treated with directional atherectomy prior to DCB use.
"DEFINITIVE AR was the first, and only
randomized pilot study to determine
the outcome differences between patients who were treated
with directional atherectomy and DCB and DCB alone. While
the data demonstrated positive, early trends towards
combination therapy in some lesion subsets, further
investigation is needed to determine the effectiveness
of debulking a lesion with directional atherectomy prior
to DCB," said Dr. Mark Turco, medical director of the Aortic &
Peripheral Vascular Business within Medtronic's Cardiac and
Vascular Group. "It is an honor for Medtronic to partner with
VIVA and a multi-disciplinary team of clinicians in the study. We
are pleased to support research in advancing therapy
options for patients with PAD."
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 Directional Atherectomy
Devices
Medtronic's directional atherectomy
portfolio includes the HawkOne(TM), TurboHawk(TM) and
SilverHawk(TM) systems. The systems are designed to remove a
variety of plaque morphologies from the peripheral vessels in
patients with PAD, and permit the restoration of blood flow known
as revascularization.
Medtronic's directional atherectomy portfolio is
backed by more than 15 peer-reviewed studies. Recent published data
from the DEFINITIVE LE study in the Journal of
American College of Cardiology, Cardiovascular Interventions
demonstrated 95 percent limb salvage in patients with critical limb
ischemia (CLI) and 78 percent overall patency (the ability for the
treated artery to remain open) in claudicant patients at 12 months
following standalone treatment with directional atherectomy
(SilverHawk and TurboHawk).i
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 VIVA
PHYSICIANS
VIVA Physicians is a not-for-profit organization dedicated to
advancing the field of vascular medicine and intervention through
education and research.
Since 2003, VIVA Physicians has held an annual
multidisciplinary vascular education conference for physicians and
healthcare professionals dedicated to treating patients with
vascular diseases. Attendees learn the most current diagnostic
techniques and leading edge treatment strategies utilizing
innovative technologies and creative learning platforms. The world
renowned faculty emphasizes unbiased and critically evaluated
educational content that highlights multidisciplinary perspectives
and collaboration.
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.
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-
i McKinsey
J, Zeller T, Rocha-Singh K, Jaff M, Garcia L, DEFINITIVE LE
Investigators. Lower Extremity Revascularization Using Directional
Atherectomy: 12-Month Prospective Results of the DEFINITIVE LE
Study. JACC: Cardiovascular Interventions 2014;
7(8):923-33.
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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