MFDS Clears DeepQure's HyperQure™ for Clinical Trial in Atrial Fibrillation
The trial is designed to evaluate the safety and efficacy of laparoscopic RDN in patients with recurrent AF following pulmonary vein isolation (PVI) and resistant hypertension. It will be conducted as a multicenter, prospective, single-arm, open-label exploratory study.
HyperQure™ is a next-generation laparoscopic RDN device developed over the past decade under the leadership of Professor Chang-Wook Jeong at Seoul National University Hospital. By adopting an extravascular approach, HyperQure™ addresses key limitations of conventional intravascular RDN, offering direct anatomical access to renal nerves with the potential for improved precision and outcomes.
DeepQure is also conducting RDN clinical trials for resistant hypertension in both South Korea and the United States. Patient enrollment is nearing completion domestically, while trials are actively underway at five major academic medical centers across the U.S.
The MFDS's approval for this new indication marks an important milestone, expanding HyperQure™'s potential from hypertension to atrial fibrillation and reinforcing its technical scalability and multi-disease therapeutic potential.
HyperQure™ is ISO 13485–certified, GMP-compliant, and was designated as Innovative Medical Device No. 36 by the MFDS, underscoring its clinical relevance and breakthrough innovation.
"This approval validates HyperQure™ as a next-generation solution that overcomes the limitations of traditional RDN techniques," said a DeepQure spokesperson. "With parallel trials in resistant hypertension and now atrial fibrillation, we are accelerating our push into the global cardiovascular market with a truly differentiated solution."
About DeepQure
DeepQure is a medical technology company pioneering minimally invasive therapies for cardiovascular and autonomic nervous system disorders. Founded by experts in clinical medicine, engineering, and global healthcare, the company is focused on developing breakthrough solutions that address unmet needs in cardiovascular diseases. DeepQure is headquartered in Seoul, South Korea, with clinical programs active in both Korea and the United States.
About HyperQure™ RDN System
HyperQure™ is DeepQure's proprietary laparoscopic renal denervation (RDN) system designed to treat conditions such as resistant hypertension and atrial fibrillation. Unlike conventional intravascular approaches, HyperQure™ utilizes an extravascular route to access and ablate renal nerves with enhanced precision. The system has been designated as an Innovative Medical Device by the Korean MFDS and has obtained ISO 13485 and GMP certifications, enabling global clinical deployment.
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