The Specialist Forum Volume 13 No 11 November 2013 | Page 74

ADVERTORIAL

Novel catheter-based
treatment for hypertension

What is the rationale for renal denervation (RDN)?
The nerves leading in and out of the kidneys play a central role in
sympathetic nervous system hyperactivation, which is an established
contributor to hypertension (high blood pressure). Surgical disruption
of sympathetic nerves has been a proven method for lowering blood
pressure. RDN therapy with the Symplicity Renal Denervation System
represents a breakthrough and first-of-its-kind device-based treatment
for resistant hypertension, which is a significant global healthcare problem affecting approximately 1.2 billion people worldwide and directly
associated with increased risks of heart attacks, stroke, heart failure,
kidney disease and death.

How does RDN work?
RDN addresses uncontrolled hypertension by reducing the drive of the
sympathetic nervous system, which is central to blood pressure regulation. It is a minimally invasive procedure that modulates the output of
the sympathetic nerves located outside the renal artery walls.

What is the procedure?
The Symplicity Renal Denervation System accomplishes RDN using a
system consisting of a proprietary generator and a flexible catheter. The
catheter is introduced through the femoral artery in the upper thigh and
is threaded through the renal artery near each kidney. Once in place,
the tip of the catheter delivers low-power radio frequency (RF) energy
according to a proprietary algorithm, or pattern, to modulate the surrounding sympathetic nerves.
RDN does not involve a permanent implant.

What impact does the procedure have on the
patient?
Clinical research shows that RDN therapy with the Symplicity Renal
Denervation System can provide significant and sustained reduction
in blood pressure levels for patients with uncontrolled blood pressure
despite multiple antihypertensive medications. This research includes
Symplicity HTN-15 and Symplicity HTN-26.
Symplicity HTN-1 was a series of pilot studies involving 153 patients
at 19 centres in Australia, Europe and the USA. In these studies,
patients achieved a mean blood pressure reduction of -25/-11 mmHg
at six months and the reduction was sustained through 24 months.
There was no evidence of vascular injury or stenosis at the treatment
sites at six months, confirmed by imaging (CTA/MRA), and renal function was sustained (eGFR and creatinine). These data were published
in the April 2009 issue of The Lancet.
Symplicity HTN-2 was a randomised, controlled clinical trial of 106
patients in Europe, Australia and New Zealand.
Patients randomised to RDN therapy achieved a mean blood
pressure reduction of 32/12 mmHg at six months, whereas patients
in the control group randomised to receive antihypertensive medications alone had blood pressures that did not vary from baseline
(1/0 mmHg).
The investigators noted no serious procedure- or device-related
events and the overall occurrence of adverse events did not differ
between groups. These data were published in the November 2010
issue of The Lancet.
References available on request.

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November 2013 | Cardiology & Stroke Forum