On Friday, Medtronic (NYSE:MDT) reported strong data Friday from an overseas clinical trial that showed that its novel renal denervation therapy for uncontrolled hypertension worked and did not adversely affect the kidneys six months after treatment.
Renal denervation is used to treat uncontrolled hypertension, or high blood pressure, by the ablation of the nerves that line the renal arteries using a catheter. Many companies see the promise of this new therapy, said an analyst on Friday
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Medtronic’s Symplicity renal denervation system is approved in Europe and the company is currently enrolling patients in a clinical trial that will bolster its case as it seeks approval from the U.S. Food and Drug Administration. A Medtronic spokeswoman said that the trial will encompass up to 90 U.S. medical centers and involve about 530 patients.
The trial is expected to complete enrollment in the third quarter of the companies fiscal year 2013, which will end in late January.
Analyst Debbie Wang of Morningstar noted that while Medtronic is ahead of the pack in terms of commercializing this kind of therapy, it is not the only company developing such products. The reason? It is a gigantic market — in the U.S. alone it could well be $5 billion, estimates Wang.
St. Jude Medical is hoping its renal denervation system is approved before the end of 2012. Wang estimated that the company is probably two to three years behind Medtronic in the U.S.
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But there are a whole host of smaller companies looking to build products around renal denervation therapy.
“At least 23 companies, mainly smaller, private companies are developing products,” Wang said, based on information she gathered at the American College of Cardiology Conference in Chicago in March.
For instance ReCor Medical in Germany, which recently won the CE Mark in Europe to market its Paradise system.
Wang added that renal denervation therapy prompted two questions once it was evident that it works: Does it affect the kidneys negatively? And, are the results durable?
Aside from Medtronic’s six-month data, even two-year studies show that there is no adverse impact on the kidney and that the therapy results appear to be long lasting, she said. The therapy also works very quickly because studies have shown that patients’ blood pressure medications had to be adjusted soon after renal denervation was administered.
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