A GlobalData report estimates the renal denervation catheter market will be worth $533m by 2033, growing at a CAGR of 26%. Image Credit: Hodoimg / Shutterstock.

Chinese company SyMap Medical has received a Class III medical device approval for its msRDN selective renal denervation system from China’s National Medical Products Administration (NMPA).

The company’s msRDN system consists of a renal artery radiofrequency ablation catheter and a console capable of administering electronic stimulation and radiofrequency ablation. The device can also map renal nerve sites to selectively denervate the sympathetic nerves.

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Renal denervation systems use radiofrequency or ultrasound to ablate afferent and efferent nerves in the renal artery which communicate with the brain and help control blood pressure. Reducing the functionality of these pathways leads to various blood pressure-reducing mechanisms. These procedures are useful in the treatment of uncontrolled hypertension.

The msRDN device approval was based on the positive data from the interventional, sham-controlled SMART trial (NCT02761811). The study met its primary endpoint by reducing the 24-hour ambulatory blood pressure by 10.8mmHg at six months.

The msRDN therapy also reduced the drug burden of hypertension patients and reduced the office systolic blood pressure at less than 140mmHg, with only four targeted ablations per renal main artery.

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A GlobalData report estimates the renal denervation catheter market will be worth $533m by 2033, growing at a compound annual growth rate (CAGR) of 26%. Multiple companies have developed renal denervation systems.

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In June, DeepQure started an early feasibility study for its renal denervation system, HyperQure. The device was granted investigational device exemption (IDE) by the US Food and Drug Administration (FDA) with the new study set to examine the safety and efficacy of the device in 15 patients at hospitals across the US. In February, SoniVie completed enrolment in the REDUCED-1 pilot study (NCT05372679) evaluating its TIVUS (therapeutic intra-vascular ultrasound) system.

Medtronic has had mixed results with its renal denervation system, Symplicity Spyral renal denervation system. Last August, the FDA advisory panel snubbed Medtronic’s device. Although the panel was convinced of the device’s safety, its efficacy was a point of much discussion as one of the Simplicity device trials, SPTRAL HTN-ON MED (NCT02439775), failed to meet its primary endpoint. In May, the company received some reprieve as China’s NMPA cleared the device.