) continues strongly with its Symplicity renal denervation
system. Following last week's news of its Investigational Device
Exemption ("IDE") submission to the US Food and Drug
Administration ("FDA") for Symplicity HTN-4, recently the company
came up with its 2-years encouraging data from its first
randomized study called Symplicity HTN-2.
Symplicity HTN-2 evaluated the Symplicity renal denervation
system. Results showed a significant decline in blood pressure in
the patients after two years. The data demonstrates that
Medtronic's Symplicity renal denervation system provides superior
and sustained blood pressure reduction in patients with
The Symplicity system was cleared in Canada by the Therapeutic
Products Directorate in the fourth quarter of fiscal 2012. While
the Symplicity system has received both CE Mark and Australia's
Therapeutic Goods Administration listing, it has yet to receive
approval in the U.S.
Medtronic expects the U.S. launch of the system for
treatment-resistant hypertension in fiscal 2015. Medtronic's peer
in the renal denervation space,
St. Jude Medical
), which manufactures the EnligHTN system, is yet to obtain the
U.S. Food and Drug Administration clearance.
Hypertension is a primary risk factor for cardiovascular
events such as stroke, heart attack or heart failure. Even with
optimal drug therapy, 30% of the patients remain in conditions of
uncontrolled hypertension. Treatment-resistant hypertension
affects approximately 120 million globally and approximately 300
million patients would need some sort of additional therapy by
Accordingly, this indication alone holds a $2−$2.5 billion market
opportunity by 2020, excluding the other potential applications
of renal denervation. With a largely underpenetrated market, the
expected launch of the Symplicity system in the U.S. is an
opportunity to drive growth. Also, worth mentioning in this
context is Medtronic's ongoing clinical trial for the Symplicity
system in Japan.
Approval in two of the largest markets for medical devices will
enable Medtronic to garner sizeable revenues for its Cardiac and
Vascular franchise. This should have a profound impact on the
company's growth trajectory in the long-term.
Medtronic now carries a Zacks Rank #3 (Hold). Other medical
device stocks worth a look are
). Both the stocks carry a Zacks Rank #1 (Strong Buy).
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