DeepQure Secures Approval for HyperQure Clinical Trials
DeepQure Gains Ground in Clinical Trials with HyperQure™
DeepQure has recently received a significant advancement in its research journey. The Ministry of Food and Drug Safety (MFDS) has given the green light for clinical trials involving HyperQure™ RDM System, a groundbreaking technology aimed at tackling atrial fibrillation (AF). This approval is set to propel DeepQure into the forefront of cardiac treatment innovation.
Trial Overview and Purpose
Designed as a multicenter, prospective, single-arm, open-label exploratory study, the trial's primary focus is to assess the safety and efficacy of laparoscopic renal denervation (RDN) for patients who experience recurrent AF following pulmonary vein isolation (PVI) and suffer from resistant hypertension. This comprehensive approach aims to generate valuable data on the effectiveness of this novel device.
What Makes HyperQure™ Unique?
HyperQure™ represents the culmination of over ten years of development led by esteemed Professor Chang-Wook Jeong at a prominent medical institution. The device utilizes an extravascular approach, differentiating it from traditional intravascular RDN devices. This unique design allows healthcare professionals to access renal nerves more precisely, potentially enhancing patient outcomes and surgical effectiveness.
Clinical Trials Expansion
In addition to its focus on atrial fibrillation, DeepQure is simultaneously conducting clinical trials for resistant hypertension in both domestic and international markets. Patient enrollment for these trials in Korea is reaching its final stages, while active participation in pivotal studies is well underway across major academic centers in the U.S., showcasing the company’s commitment to advancing its clinical reach.
Milestone Achievement
The recent MFDS approval signifies a major milestone for DeepQure, extending the potential applications of HyperQure™ from just hypertension to the broader realm of atrial fibrillation treatment. This leap emphasizes the device's versatility and its potential to address multiple cardiovascular issues.
Regulatory Recognition
Notably, HyperQure™ has achieved ISO 13485 certification and is GMP-compliant, reaffirming its status as a reliable medical technology. Additionally, it has been designated as Innovative Medical Device No. 36 by the MFDS, highlighting its significant market readiness and innovative capabilities.
The Vision of DeepQure
A representative from DeepQure expressed confidence in the progress made, stating, "This approval validates HyperQure™ as a next-generation solution that overcomes the limitations of traditional RDN techniques." With the dual approach of running trials for both resistant hypertension and atrial fibrillation, DeepQure aims to pave the way for a comprehensive cardiovascular treatment strategy.
About DeepQure
DeepQure stands out as a pioneering medical technology firm dedicated to developing minimally invasive treatments for both cardiovascular diseases and autonomic nervous system disorders. The company, formed by a group of medical and engineering experts, is dedicated to creating solutions that cater to unmet clinical needs. Operating out of its headquarters in Seoul, DeepQure is making strides in both Korean and U.S. healthcare landscapes.
About HyperQure™ RDN System
HyperQure™ is DeepQure’s advanced proprietary laparoscopic renal denervation system, meticulously designed for managing conditions like resistant hypertension and atrial fibrillation. Its innovative extravascular technique provides enhanced access to renal nerve ablation, differing significantly from traditional methods. The recognition as an Innovative Medical Device by the MFDS and attainment of both ISO 13485 and GMP certifications set the stage for its global clinical applications.
Frequently Asked Questions
What is the HyperQure™ RDN System?
The HyperQure™ RDN System is a laparoscopic device developed by DeepQure for renal denervation, aimed at treating conditions like atrial fibrillation and resistant hypertension.
What recent approval did DeepQure receive?
DeepQure received MFDS approval to initiate clinical trials for its HyperQure™ RDN System, specifically targeting atrial fibrillation treatment.
What are the study designs for the clinical trials?
The study is a multicenter, prospective, single-arm, open-label exploratory trial focusing on safety and efficacy in patients with recurrent atrial fibrillation.
Where is DeepQure headquartered?
DeepQure is headquartered in Seoul, South Korea, where it develops its innovative medical technologies.
What certifications does HyperQure™ hold?
HyperQure™ has received ISO 13485 certification and is GMP-compliant, confirming its quality and safety in medical devices.
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