Positive Data for MDT's Symplicity HTN-2 - Analyst Blog
March 12 2013 - 1:45PM
Zacks
Medtronic (MDT) 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
treatment-resistant hypertension.
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
(STJ), 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 2020.
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 Cyberonics Inc.
(CYBX) and Given Imaging. (GIVN). Both the stocks
carry a Zacks Rank #1 (Strong Buy).
CYBERONICS INC (CYBX): Free Stock Analysis Report
GIVEN IMAGING (GIVN): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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