Approximately 10–20% of the general hypertensive population suffers from resistant hypertension, a form of hypertension where the patient’s systolic blood pressure remains over 140mmHg despite being treated with three or more anti-hypertensive medications.
Renal denervation is believed to be a ground-breaking solution for the untreated hypertensive population, potentially reducing the global burden of heart disease and stroke.
The SYMPLICITY HTN-3 trial
Medtronic’s SYMPLICITY HTN-3 clinical trial was the largest and most rigorously designed study conducted on renal denervation for treatment-resistant hypertension. As the industry eagerly looked forward to the results of the trial, its results led to major disappointment and a change to the global renal denervation market in 2014.
Medtronic’s clinical trial results revealed that although patients receiving renal denervation treatment had a large decrease in blood pressure, this was not significantly different from the control group, who also showed a drop in blood pressure. This raised the question of why patients with resistant hypertension suddenly saw a drop in blood pressure, and did they truly have resistant hypertension?
It was noted that several factors have contributed to the efficacy results despite the more rigorous study design, including questionable medication compliance and whether or not the renal nerve was actually denervated. These results forced the entire renal denervation industry to re-evaluate clinical trial designs and pause any sales and marketing efforts. Smaller companies that entered this industry with high hopes and devices in development had abandoned their research altogether.
The future of renal denervation
Following the downturn in the industry in 2014, the buzz around renal denervation devices remained fairly quiet despite some ongoing research and development. However, the conversation has since been re-opened after insights into a clinical trial that started in 2015 revealed that with a new procedural approach and learning from the mistakes of the SYMPLICITY HTN-3 trial, there were significant reductions in blood pressure in the treatment group compared to the control arm.
Despite the disappointing results from Medtronic’s clinical trial, GlobalData believes that renal denervation will make a comeback in the near future, potentially with devices released in major markets by 2018. In 2015, regulatory approval was given to several markets including Brazil, Canada, Mexico, Russia and several European countries, though the device was only marketed in a subset of these countries.
As a result of successful clinical trials, GlobalData expects renal denervation devices to be present in 15 major markets across the world by 2022 with the largest markets being the US, Germany and France. Many of the results observed from the trial were due to inherent flaws in the trial design; however, the role of renal denervation in decreasing blood pressure has not yet been disproved. With significant drops in blood pressure observed from surgical denervation of the kidney as early as the 1920s, this innovative intervention remains the closest thing to a solution for drug-resistant hypertension.
MediPoint: Renal Denervation – Global Analysis and Market Forecasts. (2016). GlobalData.