ACC 2020 – Medtronic enjoys renal denervation Lazarus moment
Medtronic’s resurrection of renal denervation for resistant hypertension is looking almost complete. Yesterday, the group revealed the Sypral HTN-Off Med pivotal trial had delivered significant reductions in blood pressure in both home and office settings in patients not taking hypertension medication. In the 331-patient sham-controlled trial, those receiving renal denervation reported 9.2mmHg reduction in office systolic blood pressure and a 4.7mmHg reduction in 24-hour systolic ambulatory blood pressure after three months. The result appears to be validation for the approach, which was all but written off following the 2014 failure of Medtronic’s original pivotal Symplicity HTN-3 trial. HTN-Off Med is, however, not registrational in itself; it will be paired with the HTN-On Med study in the more clinically relevant population of patients with high to moderate hypertension who are not adequately controlled with their existing medication. Unfortunately for Medtronic, moving quickly to take advantage of the Off Med success has been scuppered by the halting of enrolment in the On Med study, owing to the Covid-19 pandemic. Wider concerns exist about the treatment’s commercial potential, ie persuading payers an interventional procedure is justifiable over medication. These could be ameliorated by Medtronic’s decision to target treatment-resistant, high-risk and stubbornly non-compliant patients – though this will, of course, limit the potential market.