|St. Jude Medical is studying whether EnligHTN can help stave off heart attack and stroke--courtesy of St. Jude|
Devicemakers have demonstrated that renal denervation can make a substantial difference in the lives of hypertension sufferers, but now St. Jude Medical ($STJ) is kicking off a landmark study to see if the treatment can also reduce the risk of heart attack, stroke and death.
The study is an international, multi-center look at how EnligHTN, St. Jude's device, can reduce the rates of major cardiovascular events in patients with drug-resistant hypertension. St. Jude is concurrently running trials on hundreds of patients around the world to test the device's effect on blood pressure, but the new one, dubbed EnligHTNment, is the first of its kind to examine stroke and heart attack rates.
"Initial study results have demonstrated that the EnligHTN Renal Denervation System is safe and effective in rapidly lowering blood pressure," lead investigator Thomas Lüscher said in a statement. "If these results extend into the prevention of major cardiac events, there is the potential to dramatically change how we treat these patients."
And, of importance to St. Jude, positive results could mean an expanded indication for the device. In Europe, where St. Jude and others have commercialized renal denervation technologies, the treatment is cleared for drug-resistant hypertension, and analysts believe it's only a matter of time before it's expanded to include all forms of the disease. But, if the nerve-deadening procedure proves beneficial in preventing strokes and heart attacks, that $2.8 billion market estimate bandied about could swell substantially.
Medtronic ($MDT) remains the market leader with its Symplicity device, but St. Jude is pulling out all the stops to push EnligHTN to the forefront. Last month, the company launched another trial studying how its device can help patients with less severe forms of hypertension, and St. Jude maintains that EnligHTN's multi-electrode design makes for a speedier denervation procedure than with Symplicity.
St. Jude's deep dive into renal denervation studies comes as little surprise: Facing declining demand and deafening regulatory problems in its cardiology unit, the company could certainly use the revenue flush that would come with a leading role in the soon-to-explode hypertension market.
- read St. Jude's announcement