2013-09-03 11:03:01 -
Final Clinical Outcomes from First and Longest-Running Renal Denervation
Clinical Study Presented During European Society of Cardiology Congress and
Accepted for Publication in The Lancet
MINNEAPOLIS AND AMSTERDAM -- September 3, 2013 -- Medtronic, Inc. (NYSE: MDT),
announced today at the European Society of Cardiology (ESC) Congress the final
three-year results from Symplicity HTN-1, the first and longest running clinical
study investigating the safety and efficacy of renal denervation, which also
have been accepted for publication in The Lancet. Eighty-eight (88) treatment-
resistant hypertension patients were available for 36 month evaluations
following treatment with the Symplicity(TM) renal denervation system. These 88
patients demonstrated sustained reductions in blood
pressure year-over-year with
an average reduction of -32/-14 mm Hg [p<0.01]. Of these 88 patients,
approximately 50 percent achieved goal of a systolic blood pressure <140 mm Hg
despite having a mean systolic blood pressure of 169.8 mm Hg pre-denervation.
There were very few clinically significant late adverse events reported through
three years of follow up.
"We are pleased to find that we're seeing sustained and significant blood
pressure reductions overall in all patients who reached the three year time
point following their denervation procedure. Achieving goal of below 140 mm Hg
in about half of these patients is impressive considering that these patients
had very high baseline blood pressures despite being on multiple pharmaceutical
agents," said Professor Henry Krum, Principal Investigator of Symplicity HTN-1
and Chair of Medical Therapeutics, Professor of Medicine and Director of the
Monash Centre of Cardiovascular Research and Education in Therapeutics,
Melbourne, Australia who presented the data today at ESC. "These were patients
who were out of hypertension treatment options before they received renal
denervation, so reductions of blood pressure of this magnitude may dramatically
decrease their risk for stroke, heart attack, heart failure and kidney disease
in the years to come."
Symplicity HTN-1 is a series of pilot studies at 19 centers in Australia, Europe
and the United States. The open-label studies enrolled 153 patients with
treatment-resistant hypertension, defined as having a systolic blood pressure
>=160 mm Hg while taking >=3 antihypertensive drugs at optimal dosages,
including a diuretic. The patients consented to be followed for either one, two,
or three years after treatment with renal denervation. Follow-up is now complete
for the 88 patients who were followed to three years. Symplicity HTN-1 is the
largest cohort of patients with the longest follow up data for renal denervation
Patients treated with renal denervation experienced consistent reductions in
blood pressure regardless of advanced age, the presence of diabetes or impaired
baseline renal function. Safety follow-up between 24 and 36 months demonstrated
continued stable renal function; two orthostatic hypotension events in one
subject resolved with medication changes, and one renal artery stenosis at 24
months, possibly related to the renal denervation procedure. Adverse events due
to co-morbid diseases such as infection and non-renal surgical complications
were also reported.
About Treatment-Resistant Hypertension
Approximately 120 million people with high blood pressure worldwide are
considered to have uncontrolled hypertension, with systolic blood pressures at
or above 140 mm Hg, despite all efforts to control blood pressure with both
lifestyle and medical management strategies.(1, 2, 3 )Uncontrolled hypertension
is associated with a hyperactive sympathetic nervous system and is directly
linked with a high risk of heart attacks, stroke, heart failure, kidney disease
and death. Most patients living with uncontrolled hypertension are prescribed
three to five classes of anti-hypertensive medications, which can equate to
taking four or more pills each day and are subsequently subjected to numerous
side effects that may negatively impact quality of life.
About the Symplicity(TM) Renal Denervation System
The Symplicity renal denervation system is backed by more than five years of
clinical experience in more than 8,000 patients with uncontrolled hypertension
and is available in more than 80 countries throughout the world. The Symplicity
system is a minimally invasive, device-based treatment option available to those
with sympathetic over-activation. It consists of a flexible catheter and
proprietary generator with which algorithms were carefully and specifically
developed through years of clinical experience to enhance the safety and
effectiveness of the renal denervation procedure. The Symplicity system received
CE (Conformité Européene) Mark in 2008. The Symplicity renal denervation system
is currently available for investigational use only in the United States.
About the Symplicity Clinical Trial Program
Medtronic continues to lead the advancement of research and development in renal
denervation worldwide with more clinical studies ongoing than any other
manufacturer with the longest follow-up data out to three years. Medtronic's
rigorous clinical evaluation program of the Symplicity renal denervation system
involves more than 8,000 patients worldwide, including the U.S., Europe and
Japan, with more than 1,200 of these patients participating in randomized
* Symplicity HTN-1: A series of pilot studies at 19 centers in Australia,
Europe and the United States with 153 patients with systolic blood pressure
>=160 mm Hg enrolled. Symplicity HTN-1, the longest running clinical trial
investigating the safety and efficacy of renal denervation.
* Symplicity HTN-2: A randomized, controlled clinical trial of 106 patients
at 24 centers in Europe, Australia and New Zealand to investigate renal
denervation in patients with treatment-resistant hypertension randomly
allocated in a one-to-one ratio to undergo renal denervation with previous
treatment or to maintain previous treatment alone.
* SYMPLICITY HTN-3: Pivotal U.S. clinical trial of the Symplicity renal
denervation system for uncontrolled hypertension completed enrollment of
535 patients across nearly 90 U.S. medical centers in May 2013. The results
are expected to be available during the first half of 2014.
* SYMPLICITY HTN-4: First randomized, controlled trial to investigate renal
denervation for moderate uncontrolled hypertension in U.S. patients with
systolic blood pressure greater than or equal to 140 and less than 160 mm
Hg. Enrollment is expected to begin in fall 2013.
* Global SYMPLICITY Registry: Prospective, multi-center, open-label registry
of 5,000 patients in 200+ centers, designed to document the long-term safety
and effectiveness of renal denervation in real-world patient populations, as
well as gather data for other diseases characterized by elevated sympathetic
* SYMPLICITY-HF: Clinical study designed to evaluate the safety and
physiologic response to renal denervation with the Symplicity system in
patients with chronic heart failure and renal impairment. The study will
enroll approximately 40 adult subjects with chronic heart failure and renal
impairment in Europe and Australia.
* Symplicity Spyral(TM) Catheter Feasibility Study: Prospective, single-arm,
non-randomized clinical study of Medtronic's multi-electrode catheter, which
completed enrollment of 50 patients in Australia and New Zealand designed to
evaluate acute procedure safety and change in office blood pressure from
baseline at six months.
* Symplicity HTN-Japan: Open-label study being conducted in approximately 100
patients across 11 centers in Japan, designed to randomize subjects 1:1 to
renal denervation versus no denervation with both groups receiving maximal
tolerated doses of antihypertensive medications.
* Symplicity HTN-India: Open-label study being conducted in approximately 40
patients across several centers in India, designed to evaluate the safety
and efficacy of renal denervation in the local population.
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.
1 Egan, Brent M., et al. "Uncontrolled and Apparent Treatment
resistant Hypertension in the United States, 1988-2008." Circulation 124. 9
2 Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL,
Jr., Jones DW, Materson BJ, Oparil S, Wright JT, Jr., Roccella E, Joint National
Committee on Prevention DE, Treatment of High Blood Pressure. National Heart L,
Blood I, National High Blood Pressure Education Program Coordinating C. Seventh
report of the joint national committee on prevention, detection, evaluation, and
treatment of high blood pressure. Hypertension. 2003;42:1206----1252.
3( )Staessen JA, Li Y, Thijs L, Wang JG. Blood pressure
and cardiovascular prevention: An update including the 2003----2004 secondary
prevention trials. Hypertension research: official journal of the Japanese
Society of Hypertension. 2005;28:385----407
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