South Korean medtech firm DeepQure has announced the launch of an Early Feasibility Study examining its renal denervation (RDN) for the treatment of resistant hypertension, dubbed the HyperQure.
The launch of the prospective, multicenter, single-arm, open-label clinical trial follows after 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.
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DeepQure system is made up of an energy generator and a laparoscopic instrument designed to deliver radio frequency (RF) energy for ablation of the sympathetic nerves around the renal artery. The company says that the HyperQure is able to carry out full denervation of renal sympathetic nerves without damaging the vascular endothelium, something which has proven to be a challenge for other intravascular systems.
Chang Wook Jeong, co-founder and CMO of DeepQure said: “We are thrilled that the FDA has approved our IDE study plan. This is a significant US regulatory milestone for DeepQure, starting the feasibility study using the extravascular ablation platform in the US for the renal denervation indication. We will accelerate our global clinical trials with this IDE approval.”
At the same time first-in-human trials are being carried out using the device at sites in Korea, DeepQure says that results from those trials show strong symptomatic improvements in patients with resistant hypertension and patients who showed symptoms of uncontrolled hypertension despite taking multiple hypertensive drugs. Results found that the HyperQure system was able to significantly lower the blood pressure of the patients with no adverse events during and post-treatment.
The company is entering a busy market with a number of companies similarly receiving tentative FDA approval for their own renal denervation devices, with firms such as SoniVie with its TIVUS (therapeutic intra-vascular ultrasound) system. Additionally, a report by GlobalData estimates that the renal denervation catheter market will be worth $533m by the end of 2033, growing at a CAGR of 26% between 2023 and then.
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By GlobalDataElsewhere in the renal derivation market, Medtronic has announced the approval of its Symplicity Spyral by the National Medical Products Administration (NMPA) in China.
