It’s more good news for the Fridley, Minn.-based medical device monolith, which is still riding high on strong results for the technology released at the recent annual meeting of the American College of Cardiology.
The latest study, published yesterday in the Journal of the American College of Cardiology, shows that the catheter-based technique, in which doctors blast the nerves lining the renal artery with radiofequency energy, could be much, much cheaper and more effective than the current standard of care.
"Our results indicate that RDN might be cost-effective when compared to other, well-accepted medical treatments with an incremental cost-effectiveness ratio that is markedly below the commonly accepted threshold of $50,000 per [quality-adjusted life-year]," the researchers wrote. "Moreover, there might be an approximately 1 in 5 chance that RDN is cost-saving in the investigated cohort. Although RDN therapy represents an additional cost at time of treatment, it seems to offer great value over time."
"As our clinical trial program and this cost-effectiveness analysis indicate, renal denervation with the Symplicity system represents an opportunity for Medtronic to help millions of patients worldwide while providing cost-effective solutions to our customers and healthcare systems," Sean Salmon, president of Medtronic’s coronary & renal denervation unit, said in prepared remarks. "We will continue to strengthen our leadership position in renal denervation therapy with additional research, including similar economic and clinical analyses in additional countries."
At the ACC conference in March, Medtronic unveiled other results from 2 trials of the Symplicity system. In a series of pilot studies including 153 Australian patients, researchers found that the device proved safe and effective after 3 years, with an average blood pressure reduction of -33/-19 Hg. There was no evidence of renal impairment, no hospitalizations due to hypotension and no procedure-related serious adverse events, according to a press release.
Perhaps most significant was that patients in the pilot studies who didn’t respond early in the trial became responders over time, with 100% of patients responding to renal denervation therapy by the 3-year mark.
"The sexiest message is the fact that the non-responders are responding over time," ACC program co-chair Dr. George Bakris said at the time. "Nobody understands why, but it’s definitely a huge novel finding in terms of better understanding what this whole thing is doing. We are learning as we go."
A 2nd randomized study of 106 patients found similar results of -32/-12 Hg blood pressure reduction after 1 year among patients receiving renal denervation, with no significant decline in kidney function and no late vascular complications.