In the past few years, renal denervation has been a source of great interest and excitement given its potential to treat high blood pressure in patients whose hypertension is uncontrolled despite being on several medications.
Medtronic shelled out about $800 million plus milestone payments to acquire Ardian, the company that pioneered the Symplicity Renal Denervation System that ablates nerves to control hypertension. And then came the shocking news in January that the largest study of Medtronic's first-generation renal denervation device had failed to meet its primary efficacy end point - to lower blood pressure at the doctor's office six months following the procedure. A few weeks later Covidien announced that it was pulling the plug on its OneShot renal denervation product because of slow growth in Europe
Given that everyone was looking to Medtronic to lead this category, and the fact that it was ahead of its competition in the U.S. has largely meant that interest in this particular therapy has waned. But St. Jude Medical CEO Dan Starks likely believes it would be a mistake to dismiss renal denervation altogether.
In the company's second-quarter earnings call with analysts and investors Wednesday, Starks said St. Jude's renal denervation program is progressing and should deserve high priority, according to a transcript of the call from SeekingAlpha.
Although renal denervation has suffered a setback due to the result of a competitor’s clinical trial, our due diligence including takeaways from the EuroPCR and input from our medical advisors convinces us that St. Jude Medical's renal denervation program can be successful and continues to deserve high priority.
But Starks was scant on the details:
We will not say more at this time for competitive reasons, but investors should know that we are continuing to move forward with planning our confidential research and development and with clinical trials in the area of renal denervation for treatment resistant hypertension.
In other words, just trust me. Where does this confidence come from?
When Medtronic announced that it had failed to meet the primary efficacy point of lowering blood pressure in the doctor’s office six months following the procedure, Starks speculated that the technology may not be up to snuff.
“We note that the trial was done with a first-generation technology,” Starks told a room full of investors and analysts at the JPMorgan Healthcare Conference in San Francisco, in January. “It may be that, among other things, the technology was too early stage. Was the technology too hard to be used effectively in an expanded environment? Was there a placebo effect? The news raised more questions than it provided answers.” :
Even in 2012, analysts were questioning whether Medtronic would be able to keep its lead in the space with a first-generation product. The criticism revolved around the fact that Medtronic’s product being tested globally had only a single electrode with which to stimulate the renal artery. Some have said the product was hard to manipulate.
Compared to that, St. Jude Medical’s EnligHTN renal denervation has multiple electrodes. But the coast is not exactly clear for St. Jude to grab the mantle from Medtronic. There are competitors in the renal denervation space from the likes of Boston Scientific and its own Vessix renal Denervation System.
All companies in this market want a piece of the global hypertension market estimated to be in the billions.
[Photo Credit: iStockphoto.com user Palto]
CORRECTION: A previous version of the story erroneously described renal denervation as a procedure involving an implantable device. The procedure actually involves ablation using a catheter.