2013-05-23 12:02:02 -
Milestone Marks a Critical Step Forward in Bringing Renal Denervation to
Patients in the U.S.
MINNEAPOLIS - May 23, 2013 - Medtronic, Inc. (NYSE: MDT), today announced it has
finished randomizing Symplicity HTN-3, the company's pivotal U.S. clinical trial
of the Symplicity(TM) renal denervation system for treatment-resistant
hypertension. Renal denervation is a minimally invasive, catheter-based
procedure to reduce activity of the renal (kidney) nerves, which are part of the
sympathetic nervous system and help regulate blood pressure. The Symplicity
renal denervation system is available in more than 70 countries worldwide; it is
only available for investigational use in the
U.S. and Japan.
The Symplicity renal denervation system is also one of the first medical devices
to participate in the U.S. Food and Drug Administration (FDA) and the Centers
for Medicare & Medicaid Services (CMS) parallel review program, which will allow
the CMS to begin national coverage determination while the FDA completes its
review of safety and efficacy. Data from the Symplicity HTN-3 clinical trial
will be a significant component of the parallel review.
"Paralleling the increased prevalence of obesity, treatment-resistant
hypertension has emerged as a major health problem in the Western world. The
results of this study will provide the medical community with data that will not
only further our understanding of the impact of renal denervation on treatment-
resistant hypertension, but also potentially help bring a new treatment option
to people in the U.S. affected by this condition," said George Bakris, M.D.,
professor of medicine and director of the ASH Comprehensive Hypertension Center
at the University of Chicago Medicine and past-president of the American Society
of Hypertension, and co-principal investigator of Symplicity HTN-3.
Symplicity HTN-3 is Medtronic's first blinded, randomized, controlled trial
designed to evaluate the safety and effectiveness of renal denervation with the
Symplicity renal denervation system in patients with treatment-resistant
hypertension in the U.S. The trial randomized 530 patients across nearly 90
medical centers in the U.S. to receive either renal denervation and treatment
with anti-hypertensive medications or treatment with anti-hypertensive
medications alone. The primary endpoints of the study are the change in blood
pressure from baseline to six months following randomization and the incidence
of major adverse events one month following randomization and renal artery
stenosis to six months.
"Because patients had to meet the most strict inclusion criteria of any renal
denervation clinical trial to date, enrollment in Symplicity HTN-3 was at first
challenging," said Deepak L. Bhatt M.D., M.P.H., chief of cardiology, VA Boston
Healthcare System, director, Integrated Interventional Cardiovascular Program,
Brigham and Women's Hospital and VA Boston Healthcare System, professor of
medicine, Harvard Medical School, and co-principal investigator of Symplicity
HTN-3. "The Symplicity HTN-3 study investigators and research coordinators
should be recognized for their leadership in addressing initial recruiting
challenges to complete this seminal clinical trial."
ABOUT THE SYMPLICITY CLINICAL PROGRAM
Medtronic is committed to advancing the research and development of renal
denervation worldwide, as demonstrated by the rigorous Symplicity clinical
program. The program is comprised of a series of trials, including the
Symplicity HTN-1 and Symplicity HTN-2 studies, both complete, and the Global
SYMPLICITY Registry, which is currently enrolling. The robust SYMPLICITY global
dataset with planned follow-up to 5 years will evaluate blood pressure reduction
as well as long-term cardiovascular outcomes from hypertension such as stroke,
myocardial infarction, heart failure and cardiovascular death. In total,
Medtronic's global Symplicity clinical program will involve more than 8,000
patients worldwide. It is through these studies that Medtronic will continue to
grow the substantial body of evidence to support the use of renal denervation in
conditions associated with hyperactive sympathetic nervous system drive,
including treatment-resistant hypertension.
"The completion of enrollment in the Symplicity HTN-3 trial brings physicians
and treatment-resistant hypertension patients in the U.S. one step closer to
having access to this innovative technology," said Nina Goodheart, vice
president, general manager, Renal Denervation, Medtronic. "This important
milestone reinforces Medtronic's strong commitment to increasing the collective
understanding of renal denervation through our global clinical development
program for our Symplicity renal denervation portfolio."
ABOUT THE SYMPLICITY(TM) RENAL DENERVATION SYSTEM
The Symplicity renal denervation system consists of a flexible catheter and
proprietary generator. In an endovascular procedure, similar to an angioplasty,
the physician inserts the small, flexible Symplicity catheter into the femoral
artery in the upper thigh and threads it into both renal arteries in turn. Once
the catheter tip is in place within the renal artery, the Symplicity generator
is activated to deliver a controlled, low-power radio-frequency (RF) energy
routine according to a proprietary algorithm aiming to deactivate the
surrounding renal nerves. This, in turn, reduces hyper-activation of the
sympathetic nervous system, which is an established contributor to chronic
hypertension. The procedure does not involve a permanent implant.
The Symplicity system's catheter and proprietary generator and algorithms were
carefully and specifically developed through years of clinical experience to
treat renal denervation. The Symplicity renal denervation system has been used
for nearly six years to successfully treat more than 5,000 patients with
treatment-resistant hypertension worldwide.
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
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world.
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
- end -
Symplicity is a trademark of Medtronic, Inc. and is registered in one or more
countries of the world.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Medtronic, Inc. via Thomson Reuters ONE