Medtronic Loses $236 Million after Renal Denervation FailureMedtronic Loses $236 Million after Renal Denervation Failure
February 18, 2014
So how much did it cost Medtronic when its Symplicity renal denervation system failed to effectively treat high blood pressure in a pivotal U.S. clinical trial? The answer appears to be $236 million.That's the amount Medtronic reduced asset values by in its third quarter financial results, out Tuesday. (Figure in taxes, and the impairment charge related to renal denervation was $204 million.) "It is important to note that while we are still in the process of evaluating potential next steps for our renal denervation business, an accounting impairment charge was deemed necessary as the majority of the value of the renal denervation intangible assets were tied to the timing of U.S. approval," Medtronic chief financial officer Gary Ellis told analysts during a Tuesday conference call, transcribed by Seeking Alpha.The write down contributed to Medtronic's third quarter net earnings decreasing 23% year over year, to $762 million. Revenue was $4.16 billion, up from $4.03 billion in the third quarter of fiscal year 2013.The treatment involves applying radiofrequency ablation through a catheter to the renal artery that supplies the kidneys with blood. Until recently, medical device industry insiders had high hopes for the treatment.
Then Medtronic came out last month with the results of its Symplicity HTN-3 study, which involved a randomized 535 treatment-resistant hypertension patients in 87 U.S. medical centers. The study demonstrated that the treatment was safe. But it did not meet its goals for lowering blood pressure among those who received the treatment, versus the control group that underwent a sham procedure. Medtronic suspended enrollment in renal denervation hypertension trials in three countries where it has been seeking regulatory approval: the United States, Japan, and India. And Covidien soon announced that it is exiting its OneShot renal denervation program, which involves technology Covidien acquired through its April 2012 acquisition of Maya Medical.Other medical device companies remain more optimistic about the treatment. Boston Scientific CEO Michael Mahoney has repeated that the medical device giant remains enthusiastic about renal denervation as a treatment for high blood pressure. St. Jude CEO Daniel Starks has expressed similar sentiments
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