REALITY Trial Enrolls First Patient in Study Evaluating Medtronic Directional Atherectomy and Drug-Coated Balloon in PAD Trea...
July 27 2016 - 03:15PM
VIVA Sponsored
REALITY Study Assessing Vessel Preparation and
Treatment in Severe Calcified Lesions Expands to Germany; Principal
Investigators Named; First Patient Enrolled
DUBLIN and SAN JOSE, Calif. -July
27, 2016 - Medtronic plc (NYSE: MDT) and
VIVA Physicians today report the first patient enrolled in the
REALITY Study. The VIVA sponsored study is assessing outcomes for
patients with significantly calcified and symptomatic
femoropopliteal peripheral artery disease (PAD), following
adjunctive use of directional atherectomy and drug-coated balloon
(DCB). Krishna Rocha-Singh, M.D., chief scientific officer, Prairie
Heart Institute of Illinois, and Brian DeRubertis, M.D., FACS,
associate professor of surgery, UCLA Division of Vascular Surgery,
are co-principal investigators. The study will include
investigative sites both within the U.S. and in Germany.
"PAD is a complex and progressive disease. The
severity of the disease can often have an impact on treatment
options for patients. Long lesion length and severe calcification
are obstacles that challenge both our ability to gain acute luminal
gain and to maintain long-term patency," said Dr. Rocha-Singh.
"REALITY is driven by the need to look at a viable treatment
paradigm that combines the use of directional atherectomy and DCB
therapy to address the challenges of treating complex PAD."
Roger Gammon, M.D., interventional cardiologist at
Austin Heart Central-Heart Hospital, treated the first patient
enrolled in the study. "We know that directional atherectomy and
DCB perform well as standalone treatments; and early data suggests
that combined therapy may improve patient outcomes in more complex
lesions. Through REALITY we hope to answer this critical question
with rigorous clinical data in this well designed study," said Dr.
Gammon.
The REALITY Study evaluates patient outcomes with
adjunctive use of Medtronic HawkOne (TM) or Medtronic TurboHawk(TM)
and Medtronic IN.PACT(TM) Admiral(TM) drug-coated balloon. The
multi-center, international, prospective, single-arm study will
enroll up to 250 subjects at up to 15 sites. The study includes
angiographic and duplex ultrasound core lab adjudication. Primary
patency is assessed by duplex ultrasound at 12-months. Patients are
followed up to 24 months to determine clinically driven target
lesion revascularization (CD-TLR). The study is sponsored and
managed by VIVA Physicians with support from Medtronic through an
external research project grant.
"Medtronic is committed to improving
patient lives through unique clinical partnerships, exemplified by
the REALITY Study," said Mark Pacyna, vice president and
general manager of the Peripheral business, which is part of
the Aortic & Peripheral Vascular division at
Medtronic. "This study is designed to further refine the PAD
treatment algorithm by providing greater evidence for vessel
preparation with directional atherectomy prior
to treatment with DCB."
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.
VIVA Physicians continues to advance the design,
execution and publication of high quality, independently
adjudicated clinical trials that promote the safe and effective use
of novel medical devices in the treatment of patients with advanced
peripheral artery disease.
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-
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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