- Clinical trials of renal denervation systems in development at two Chinese companies have met their primary endpoints.
- At EuroPCR 2023, researchers shared data from trials of blood pressure devices in development at SyMap Medical and Shanghai Golden Leaf MedTec. Both trials suggest the approach is safe and has some benefits.
- The findings provide further validation of a technique used by Medtronic and ReCor Medical, while suggesting the U.S. companies will face competition if they target the Chinese market.
Medtronic and ReCor have rehabilitated the reputation of renal denervation as a treatment for hypertension in recent years with data showing selective ablation of the renal arteries can reduce high blood pressure. The companies are competing for the European market, where cardiologists recently recommended renal denervation, and are closing in on approval decisions in the U.S.
Cardiologists in Asia recommended renal denervation as an initial therapy option in 2020, partly on the basis of Medtronic data, but the region is also a source of competitors for the U.S. companies. Data on two rival devices was presented at EuroPCR 2023 this week, as TCTMD reported.
One study looked at a device in development at SyMap, a Chinese medtech company that raised a $100 million financing round late in 2021. The clinical trial randomized 219 people, who had uncontrolled blood pressure despite taking two or more hypertension medicines, to undergo renal denervation using the SyMapCath I catheter or a placebo treatment.
Six months later, office blood pressure had fallen by 25mmHg in the treatment group. However, with blood pressure in the control group falling 27mmHg, the treatment failed to show superiority over the sham treatment. Renal denervation did have an advantage in terms of drug use, with a measure of the need for more medications or higher doses rising by less in the treatment arm than the control group.
The other clinical trial, which tested Shanghai Golden Leaf’s Netrod system, linked renal denervation to reduced blood pressure compared to the placebo control. Mean office blood pressure fell 25mmHg in the treatment group, compared to 6mmHg in the control arm. While renal denervation had similar effects in both trials, the response to the sham treatment was higher in the SyMap study.
Shanghai Golden Leaf raised money to advance its renal denervation system late last year. Given that there were 274 million people with hypertension in China in 2018, Shanghai Golden Leaf and SyMap could access a large patient population even if they only target their home market.