Of late, a flow of events has kept medical devices major Medtronic (MDT) busy. While the company is on the verge of solidifying itself in its new role of a health care services and solutions provider, it is definitely not losing focus over its original wing.
Recently, the company presented the final three-year clinical outcomes data from Symplicity HTN-1 at the European Society of Cardiology (ESC) Congress. This is the first and lengthiest clinical study to examine the safety and efficiency of renal denervation. The study will also be published in the Lancet journal.
The study was conducted on 88 treatment-resistant hypertension patients treated with the Symplicity(TM) renal denervation system. These patients were evaluated for three years. According to the company, the study demonstrated continued blood pressure reduction on a yearly basis, with an average reduction of -32/-14 mm Hg [p
According to Medtronic, globally almost 120 million people with high blood pressure are suffering from uncontrolled hypertension. Despite trying all possible means to control blood pressure, their systolic blood pressures remain at or above 140 mm Hg.
Medtronic is currently conducting several clinical trials on the Symplicity HTN. Earlier this month, the company presented new data from the Global SYMPLICITY Registry that continues to affirm the strong safety profile of the Symplicity renal denervation system in a real-world patient population. Notably, the Symplicity system received CE (Conformité Européene) Mark in 2008 and is currently available for investigational use only in the U.S.
Late August, Medtronic’s major peer in this space, St. Jude Medical (STJ) won the CE Mark approval for its second-generation EnligHTN Renal Denervation System, a competing product of Simplicity Renal Denervation System. The first-generation EnligHTN device already received the CE Mark approval in May 2012 and is now commercially available in several markets. However, both the devices are yet to receive an approval from the U.S. regulatory agency.
Despite tough competition, we believe that the final clinical outcomes from Symplicity HTN-1 will contribute largely toward grasping opportunities in growing markets of renal denervation. This in turn, will help to accelerate Medtronic’s growth in the coming years.
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