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.
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