Medtronic (NYSE:MDT) said it’s closed the 1st phase of a feasibility trial for its next-generation Symplicity renal denervation device for high blood pressure.
The 9-patient trial delivered a 100% acute success rate in accessing the renal arteries and delivering the therapy, according to a press release.
"We look forward to moving forward with our clinical evaluation of this next-generation system that aims to augment our portfolio by offering more sophisticated features that should benefit both physicians and patients," Medtronic’s president of coronary & renal denervation Sean Salmon said in prepared remarks. "This feasibility study represents Medtronic’s commitment to providing physicians with a broader range of solutions for performing renal denervation and to collaborating with physician partners in the ongoing evaluation of this ground-breaking therapy."
Sign up to get our free newsletters delivered straight to your inbox
Earlier this week, the Fridley, Minn.-based medical device company touted the launch of another renal denervation trial, testing the Symplicity system against drug therapy alone in patients in Japan.
In September, Medtronic said an analysis of its Symplicity HTN 2 trial showed that the procedure is a cost-effective way to treat resistant hypertension.
And 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.
