Leading medical devices player,
) recently announced the online availability of encouraging data
from a randomized study called Symplicity HTN-2.
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Symplicity HTN-2 evaluated the Symplicity renal denervation
system. Results showed that no adverse events or device-related
complications were observed in the patients after one year.
Rather, patients under observation sustained a significant
decline in blood pressure compared to baseline at 12 months. 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 is 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 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 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.
We currently have a 'Neutral' recommendation on the stock which
carries a short-term Zacks #3 Rank (Hold). Its peers in the
) carry a Zacks #2 Rank (Buy).