Medtronic’s Renal Denervation System safe, but fails efficacy trials in the U.S.
Medtronic, Inc. has announced that its crucial U.S. trial in renal denervation for treatment-resistant hypertension, SYMPLICITY HTN-3, has failed to meet its primary efficacy endpoint.
SYMPLICITY HTN-3 is the first blinded, randomized, controlled trial designed to evaluate the safety and effectiveness of the Symplicity system in U.S. patients with treatment-resistant hypertension and systolic blood pressure over 160 mmHg. Follow-up for all 535 patients with treatment-resistant hypertension in 87 U.S. medical centers who were involved in the trial, will continue as planned out to five years.
The company said in a statement that there were no safety concerns in the study and patients who have had the renal denervation procedure with the Symplicity system do not have to take any specific action.
According to co-principal investigator, George Bakris, M.D., “while it’s disappointing the trial did not meet its primary efficacy endpoint, this is the most rigorous renal denervation clinical trial conducted to date, and the first of its kind to include a sham-control group. We look forward to advancing these data into the peer-review process and will submit these findings for presentation and scientific discussion at an upcoming scientific congress.”
Another study investigator said she did not think this is the end of renal denervation and that it may have just been the wrong approach and a learning curve. There are another 30 different methods being tested to denervate the renal arteries in an attempt to lower high blood pressure!
Based on these clinical trial findings, Medtronic intends to create a panel of independent advisors comprising physicians and researchers to make recommendations about the future of the global hypertension clinical trial program, as well as provide advice on continued physician and patient access to the Symplicity technology in countries with regulatory approvals.
Until such a review, the company will suspend enrollment in the three countries where renal denervation hypertension trials are being conducted for regulatory approvals (SYMPLICITY HTN-4 in the U.S., HTN-Japan and HTN-India); begin informing clinical trial sites and investigators, global regulatory bodies, and customers of these findings and decisions; continue to ensure patient access to the Symplicity technology at the discretion of their physicians in markets where it is approved; and continue the Global SYMPLICITY post-market surveillance registry and renal denervation studies evaluating other non-hypertension indications.
The results follow the announcement last month that the pivotal trial for St. Jude Medical’s renal denervation system ―EnligHTN-IV ― was stopped after enrolling fewer than 10 patients, because of anticipated recruitment difficulties.
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