FDA News

New renal denervation trial for hypertension greenlighted by FDA

Medtronic announced that the FDA has issued an investigational device exemption allowing the company to begin a randomized, sham-controlled pivotal trial to evaluate a renal denervation system in patients with hypertension.

The SPYRAL HTN Pivotal Trial of the system (Symplicity Spyral) will evaluate its safety and efficacy in up to 433 patients at 50 sites in the United States, Europe, Australia and Japan, according to a press release issued by the company. It follows the SPYRAL HTN-OFF MED study presented and published in August 2017, which found that catheter-based renal denervation lowered BP in hypertensive patients not treated with antihypertensive medication.

“We are entering a new era for blood pressure control with data from a rigorous sham-controlled trial showing that renal denervation significantly lowered blood pressure in the absence of antihypertension medications,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute, Atlanta, said in the release.

David Kandzari
David E. Kandzari

 

Renal denervation, a catheter-based procedure regulating the renal nerves to lower BP, garnered much interest as a potential treatment for patients with treatment-resistant hypertension, but was dealt a setback in March 2014 when the SYMPLICITY HTN-3 trial failed to show a benefit for renal denervation with a previous system (Symplicity, Medtronic).

Raymond R. Townsend

Raymond R. Townsend, MD, director of the hypertension program at the Hospital of the University of Pennsylvania and professor of medicine at Perelman School of Medicine at the University of Pennsylvania, told Cardiology Today’s Intervention that three major things have been learned since the failure of SYMPLICITY HTN-3.

“The first is the need for careful surveillance of medications,” he said. “This was identified as a potential confounder in SYMPLICITY HTN-3. In the current trials, we do drug monitoring to verify the absence of antihypertensive medications at the key points of effectiveness testing in the protocol. The second thing … is that renal denervation is more effective when there is both systolic and diastolic hypertension. The third was the importance of branch vessels beyond the main renal artery. The branch vessels are now included in current renal denervation trials.”

The new Medtronic device differs from the old one in that it has four electrodes instead of one and reduces ablation time to less than 1 minute from 2 minutes, he said.

The trial is expected to be completed in approximately 2 years, Townsend told Cardiology Today’s Intervention.

According to the release, 6-month data from the first 80 patients enrolled in the SPYRAL HTN-ON MED trial of the system in patients with uncontrolled hypertension despite medical therapy will be presented at EuroPCR in May.

For more information:

Raymond R. Townsend, MD, can be reached at townsend@upenn.edu.

Disclosures: Kandzari reports he receives institutional support for conducting clinical trials from Medtronic and research or grant support and honoraria for work unrelated to the study. Townsend reports he receives institutional support for the conduct of clinical trials and consultant fees from Medtronic.

Medtronic announced that the FDA has issued an investigational device exemption allowing the company to begin a randomized, sham-controlled pivotal trial to evaluate a renal denervation system in patients with hypertension.

The SPYRAL HTN Pivotal Trial of the system (Symplicity Spyral) will evaluate its safety and efficacy in up to 433 patients at 50 sites in the United States, Europe, Australia and Japan, according to a press release issued by the company. It follows the SPYRAL HTN-OFF MED study presented and published in August 2017, which found that catheter-based renal denervation lowered BP in hypertensive patients not treated with antihypertensive medication.

“We are entering a new era for blood pressure control with data from a rigorous sham-controlled trial showing that renal denervation significantly lowered blood pressure in the absence of antihypertension medications,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at Piedmont Heart Institute, Atlanta, said in the release.

David Kandzari
David E. Kandzari

 

Renal denervation, a catheter-based procedure regulating the renal nerves to lower BP, garnered much interest as a potential treatment for patients with treatment-resistant hypertension, but was dealt a setback in March 2014 when the SYMPLICITY HTN-3 trial failed to show a benefit for renal denervation with a previous system (Symplicity, Medtronic).

Raymond R. Townsend

Raymond R. Townsend, MD, director of the hypertension program at the Hospital of the University of Pennsylvania and professor of medicine at Perelman School of Medicine at the University of Pennsylvania, told Cardiology Today’s Intervention that three major things have been learned since the failure of SYMPLICITY HTN-3.

“The first is the need for careful surveillance of medications,” he said. “This was identified as a potential confounder in SYMPLICITY HTN-3. In the current trials, we do drug monitoring to verify the absence of antihypertensive medications at the key points of effectiveness testing in the protocol. The second thing … is that renal denervation is more effective when there is both systolic and diastolic hypertension. The third was the importance of branch vessels beyond the main renal artery. The branch vessels are now included in current renal denervation trials.”

The new Medtronic device differs from the old one in that it has four electrodes instead of one and reduces ablation time to less than 1 minute from 2 minutes, he said.

The trial is expected to be completed in approximately 2 years, Townsend told Cardiology Today’s Intervention.

According to the release, 6-month data from the first 80 patients enrolled in the SPYRAL HTN-ON MED trial of the system in patients with uncontrolled hypertension despite medical therapy will be presented at EuroPCR in May.

For more information:

Raymond R. Townsend, MD, can be reached at townsend@upenn.edu.

Disclosures: Kandzari reports he receives institutional support for conducting clinical trials from Medtronic and research or grant support and honoraria for work unrelated to the study. Townsend reports he receives institutional support for the conduct of clinical trials and consultant fees from Medtronic.