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.
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