FDA News

FDA allows trial of renal denervation system to begin

David Kandzari
David E. Kandzari

Medtronic announced that the FDA has allowed the company to begin an investigational device exemption trial of a renal denervation system for treatment of hypertension in patients already taking antihypertensive medications.

The system (Symplicity Spyral, Medtronic) will be tested in the SPYRAL HTN-ON MED trial, a prospective, randomized, sham-controlled study of up to 340 patients for up to 3 years, according to a press release issued by the company.

As Cardiology Today’s Intervention previously reported, an 80-patient SPYRAL HTN-ON MED pilot study showed the system was associated with significant reductions in 24-hour and office systolic BP.

Patients in the study will be prescribed up to three antihypertensive medications and will be randomly assigned on a 2:1 basis to renal denervation or a sham procedure, according to the release. The primary safety endpoints will include major adverse events at 1 month and new renal artery stenosis at 6 months. The primary efficacy endpoint is 24-hour ambulatory BP at 6 months.

A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, principal investigator of the trial and member of the SPYRAL HTN Global Clinical Program Executive Committee, said in the release. “This trial will add yet another critical piece to the [renal denervation] evidence basis and is designed to build on the success of our pilot study, which showed a benefit for [renal denervation] in an on-med patient population.”

Disclosure: Kandzari reports he has received institutional grant or research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol and OrbusNeich, and he has received consultant fees from Biotronik, Boston Scientific, Medtronic CardioVascular and Cardinal Health.

David Kandzari
David E. Kandzari

Medtronic announced that the FDA has allowed the company to begin an investigational device exemption trial of a renal denervation system for treatment of hypertension in patients already taking antihypertensive medications.

The system (Symplicity Spyral, Medtronic) will be tested in the SPYRAL HTN-ON MED trial, a prospective, randomized, sham-controlled study of up to 340 patients for up to 3 years, according to a press release issued by the company.

As Cardiology Today’s Intervention previously reported, an 80-patient SPYRAL HTN-ON MED pilot study showed the system was associated with significant reductions in 24-hour and office systolic BP.

Patients in the study will be prescribed up to three antihypertensive medications and will be randomly assigned on a 2:1 basis to renal denervation or a sham procedure, according to the release. The primary safety endpoints will include major adverse events at 1 month and new renal artery stenosis at 6 months. The primary efficacy endpoint is 24-hour ambulatory BP at 6 months.

A broad range of patients suffer with hypertension today, many of whom remain uncontrolled despite being prescribed a variety of medications; the consequences of uncontrolled hypertension represent both a substantial impact to public health and a large unmet need in medicine for new approaches,” David E. Kandzari, MD, director of interventional cardiology and chief scientific officer at the Piedmont Heart Institute in Atlanta, principal investigator of the trial and member of the SPYRAL HTN Global Clinical Program Executive Committee, said in the release. “This trial will add yet another critical piece to the [renal denervation] evidence basis and is designed to build on the success of our pilot study, which showed a benefit for [renal denervation] in an on-med patient population.”

Disclosure: Kandzari reports he has received institutional grant or research support from Biotronik, Boston Scientific, Medtronic CardioVascular, Medinol and OrbusNeich, and he has received consultant fees from Biotronik, Boston Scientific, Medtronic CardioVascular and Cardinal Health.