Of late, a series of events has kept medical devices major Medtronic (MDT) occupied. While the company is focusing on strengthening its new role as a health care services and solutions provider, it is definitely not losing focus over its original wing.
Recently, the company randomized its first patients in SYMPLICITY HTN-4, the first U.S. renal denervation clinical study for patients with moderate uncontrolled hypertension. SYMPLICITY HTN-4 is based on SYMPLICITY HTN-3, the only other renal denervation clinical trial in the U.S. HTN-4 is Medtronic's second randomized, controlled renal denervation clinical trial in the U.S. and is currently available only for investigational purpose in the country.
Notably, in Nov 5 2013, the U.S. Food and Drug Administration (:FDA) approved an Investigational Device Exemption (IDE) allowing Medtronic to initiate SYMPLICITY HTN-4 in patients in the U.S.
Medtronic plans to enroll up to 580 patients with moderate uncontrolled hypertension for this trial at approximately 100 sites. According to Medtronic, it will target a patient population conforming with the definition of uncontrolled hypertension stated by the Joint National Committee on the Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC-7), the American Heart Association and the European Society.
By moderate uncontrolled hypertension we mean systolic blood pressure in the range of 140 and 160 mm Hg despite treatment with three or more anti-hypertensive medications of different classes. According to Medtronic, almost 120 million people with high blood pressure are suffering from uncontrolled hypertension globally. Despite trying all possible means to control blood pressure, their systolic blood pressure remains at or above 140 mm Hg.
In the U.S., only 60% of the patients have their blood pressure under control even after taking medicines.Uncontrolled hypertension increases the possibility of heart attacks, stroke, heart failure, kidney disease and death. Traditional treatment prescribes three to five classes of anti-hypertensive medications leading to many side effects.
Medtronic is currently conducting several clinical trials on Symplicity HTN. Its Symplicity HTN-3 U.S. pivotal study is the first and only pivotal U.S. clinical trial of the Symplicity renal denervation system for uncontrolled hypertension. The company completed enrollment of 535 patients across nearly 90 U.S. medical centers in May 2013. The results are expected to be declared in the first half of 2014.
In September this year, Medtronic presented the final three-year clinical outcome 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 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
The same 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.
Despite tough competition, we believe that the final clinical outcome from Symplicity HTN-4 will contribute significantly toward grasping opportunities in growing markets of renal denervation. This, in turn, will help to accelerate Medtronic’s growth in the coming years.
Medtronic currently carries a Zacks Rank #3 (Hold). Stocks that warrant a look include McKesson Corporation (MCK), Align Technology Inc. (ALGN) and Cardinal Health, Inc. (CAH). These stocks carry a Zacks Rank #1 (Strong Buy).