MDT Submits IDE for Symplicity HTN4 - Analyst Blog
March 08 2013 - 7:40AM
Zacks
Leading medical devices player –
Medtronic (MDT) 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 classes.
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 the U.S.
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 Boston Scientific (BSX) 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
Cyberonics (CYBX) and Given
Imaging (GIVN). These stocks carry a Zacks Rank #1 (Strong
Buy).
BOSTON SCIENTIF (BSX): Free Stock Analysis Report
CYBERONICS INC (CYBX): Free Stock Analysis Report
GIVEN IMAGING (GIVN): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
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