Leading medical devices player -
) recently submitted an Investigational Device Exemption ("IDE")
to the US Food and Drug Administration ("FDA") to study the
Symplicity renal denervation system, which is currently available
only for investigational use in the U.S. The study will be for
the uncontrolled hypertension patients with systolic blood
pressure in the range of 140-160 mm Hg despite treatment with
three or more anti-hypertensive medications of different
The Symplicity HTN-4 is used to build the clinical evidence
platform for the treatment of hypertension. It is based on
Medtronic's Symplicity HTN-3 study, the pivotal US clinical trial
of the Symplicity renal denervation system for the
treatment-resistant hypertension with over 160 mm Hg systolic
blood pressure. At present, Symplicity HTN-3 is the only clinical
trial to receive an IDE approval to study renal denervation in
Medtronic expects to start patient enrollment for the
Symplicity HTN-4 trial in the second half of 2013. This includes
a series of trials, comprising 5,000 patients enrolled in the
Global Symplicity Registry, 530 enrolled in the Symplicity HTN-3
study and more than 250 enrolled for the Symplicity HTN-1 and
Symplicity HTN-2 studies.
Medtronic has been witnessing disappointing performance from
defibrillators and spinal implants in the US market. However, we
are optimistic that over the long term, stability in the US
defibrillator and spinal market along with a deep
pipeline/portfolio − which includes CoreValve, Resolute
Integrity, Atrial Fibrillation, renal denervation and peripheral
businesses − will be the driving factors for the company. This
strategy of portfolio diversification has been followed by its
peers such as
) as well.
Of these driving factors, renal denervation, serving a
significant unmet clinical need in uncontrolled hypertension,
deserves special mention given its immense market potential.
Hypertension is the primary risk factor for stroke and is costing
the global health care economy $500 billion a year. The company
estimated that in the U.S., the control rate for hypertensive
patients taking medications is 60%, leaving the uncontrolled
hypertension patientsat an increased cardiovascular risk.
We believe that this indication alone holds a huge market
opportunity for Medtronic in the long run. The Symplicity system
was inducted in the company's portfolio with the acquisition of
privately-held Ardian, in Jan 2011.
The stock carries a Zacks Rank #3 (Hold). Other medical stocks
carrying a favorable Zacks Rank are
). These stocks carry a Zacks Rank #1 (Strong Buy).
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