DeepQure Receives MFDS Approval for Atrial Fibrillation Trial of Novel Laparoscopic Renal Denervation System
Key Insights
South Korea's Ministry of Food and Drug Safety has approved DeepQure (search)'s HyperQure™ (search) RDN System for clinical trials in atrial fibrillation patients with recurrent AF following pulmonary vein isolation.
The novel laparoscopic renal denervation device uses an extravascular approach to address limitations of conventional intravascular RDN techniques, offering enhanced precision and direct anatomical access to renal nerves.
This approval expands HyperQure™ (search)'s therapeutic potential beyond resistant hypertension to atrial fibrillation, with parallel trials already underway in both South Korea and the United States.
DeepQure (search) announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a clinical trial of HyperQure™ (search) RDM System, the company's novel laparoscopic renal denervation (RDN) system, for the treatment of atrial fibrillation (AF). This regulatory milestone expands the device's therapeutic scope beyond its original indication for resistant hypertension.
Trial Design and Patient Population
The approved 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. The study will be conducted as a multicenter, prospective, single-arm, open-label exploratory study, targeting a specific patient population that has experienced treatment failure with conventional AF interventions.
Technology Innovation
HyperQure™ (search) represents a next-generation laparoscopic RDN device developed over the past decade under the leadership of Professor Chang-Wook Jeong at Seoul National University Hospital. The system's key innovation lies in its extravascular approach, which addresses fundamental limitations of conventional intravascular RDN techniques.
By adopting this extravascular route, HyperQure™ (search) offers direct anatomical access to renal nerves with the potential for improved precision and outcomes compared to traditional methods. This technical advancement positions the device as a differentiated solution in the cardiovascular intervention space.
Regulatory Status and Certifications
The device has achieved significant regulatory recognition, including designation as Innovative Medical Device No. 36 by the MFDS. HyperQure™ (search) is ISO 13485-certified and GMP-compliant, meeting international standards for medical device quality and manufacturing.
Parallel Clinical Programs
DeepQure (search) is simultaneously 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™ (search)'s potential from hypertension to atrial fibrillation and reinforcing its technical scalability and multi-disease therapeutic potential.
Company Perspective
"This approval validates HyperQure™ (search) as a next-generation solution that overcomes the limitations of traditional RDN techniques," said a DeepQure (search) 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."
DeepQure (search) 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.