FDA Approves Medtronic's Study - Analyst Blog
July 12 2011 - 8:15AM
Zacks
Leading medical devices player,
Medtronic (MDT), has received conditional approval
from the US Food and Drug Administration (FDA) for a US clinical
trial called Symplicity HTN-3. The clinical trial will involve
renal denervation with Symplicity catheter system for the treatment
of resistant hypertension (high blood pressure that could not
be controlled with drugs). The device has already been approved in
both Europe and Australia.
The Symplicity HTN-3 study will
assess the effectiveness and safety of renal denervation with the
Symplicity catheter system. The study aims to enroll approximately
500 patients across 60 US medical centers. The patients will be
randomized to receive either renal denervation along with
anti-hypertensive medications or treatment with anti-hypertensive
medications alone. Primary endpoints of the study include change in
blood pressure from baseline after six months and occurrence of
major adverse events after one month of treatment.
Clinical studies till date have
demonstrated that renal denervation with the Symplicity catheter
system results in significant reduction in blood pressure levels
for many patients, who were unable to check blood pressure despite
multiple medications. Results from Symplicity HTN-2 trial, carried
out with 106 patients in Europe, Australia and New Zealand were
favorable. It was observed that patients undergoing renal
denervation experienced reduction in blood pressure, whereas blood
pressure for those in the control group (who received only
anti-hypertensive medications) did not vary. Moreover, adverse
events were similar between the groups.
The Symplicity catheter system was
included in Medtronic’s portfolio with the acquisition of
Ardian. The decision to acquire Ardian was based on the
thesis that renal denervation as a treatment for uncontrolled
hypertension has the potential to record strong growth going ahead.
Immense potential exists in this market as hypertension, affecting
about 1.2 billion people, is one of the leading causes of death
globally.
The fiscal 2011 has been one of the
most challenging years for Medtronic based on macroeconomic
downturn, decreased utilization and increased payer pushback.
Although the situation is improving gradually, the two biggest
segments of the company – CRDM and Spinal continue to remain under
pressure. Meanwhile, Medtronic is increasing its focus on emerging
markets and emerging therapies and expects these to be major growth
drivers going ahead. The company also faces tough competition from
players such as Boston Scientific Corporation
(BSX) and St. Jude Medical (STJ).
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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