With this approval, DeepQure can now conduct domestic clinical trials involving patients with recurrent atrial fibrillation after catheter ablation and those with resistant hypertension. The clinical trial will be a multicenter, prospective, single-arm, open-label exploratory study designed to evaluate the safety and efficacy of laparoscopic-based RDN.
HyperQure is a laparoscopic surgical medical device that has been developed and undergone preclinical processes for about 10 years under the leadership of Professor Changwook Jung at Seoul National University Hospital. By introducing extravascular RDN as an alternative to the conventional intravascular RDN approach, HyperQure is gaining attention as a new solution that overcomes the limitations of traditional intravascular RDN.
DeepQure is currently conducting approved RDN clinical trials for patients with resistant hypertension in both Korea and the United States. In Korea, patient enrollment is nearing completion, while in the United States, clinical trials are underway at a total of five major university hospitals.
This approval from the Ministry of Food and Drug Safety signifies more than just the initiation of a clinical trial; it also means that the application scope of the HyperQure system can be expanded from hypertension to atrial fibrillation. This is expected to serve as important evidence demonstrating the system's technological scalability and potential for multi-disease applications.
The HyperQure system has previously obtained Good Manufacturing Practice (GMP) certification and the international medical device quality management system standard ISO 13485, both of which are required for conducting global clinical trials. In addition, it has been officially recognized for its technological strength and innovation by being designated as the 36th innovative medical device by the Ministry of Food and Drug Safety.
A DeepQure representative stated, "HyperQure is an innovative solution that overcomes the limitations of existing RDN methods," adding, "With this clinical trial approval for atrial fibrillation from the Ministry of Food and Drug Safety, alongside our ongoing trials for resistant hypertension, we plan to accelerate our entry into the global market."
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