DeepQure Receives IDE Approval for EFS of HyperQure Extravascular RDN System
- 2024년 6월 9일
- 1분 분량
DeepQure Inc., a Seoul, South Korea-based medical device company, announced the initiation of its early feasibility study (EFS) for the HyperQure renal denervation (RDN) system after receiving approval of an investigational device exemption from the FDA. HyperQure is an extravascular laparoscopic device for RDN to treat resistant hypertension.
According to DeepQure, the EFS will aim to demonstrate the safety and efficacy of HyperQure in 15 patients with resistant hypertension. The clinical trial will be conducted in a prospective, multicenter, single-arm, open-label design at university hospitals in the United States.
Participating centers in the trial include Stanford University in Stanford, California; Mayo Clinic in Rochester, Minnesota; Emory University in Atlanta, Georgia; University of Arizona in Tucson, Arizona; and the University of California, Irvine in Irvine, California.
The company stated that the HyperQure system consists of an energy generator and a laparoscopic instrument that delivers radiofrequency energy for ablation directly to the sympathetic nerves around the renal artery by wrapping the renal artery 360º from outside the vessel. This mechanism is intended to allow full denervation of renal sympathetic nerves without damaging the vascular endothelium, which is a challenge for intravascular catheter systems, noted the company.
The Korean first-in-human HyperQure trial is ongoing. Initial results are showing strong symptomatic improvements in patients with resistant hypertension. The RDN treatment utilizing the HyperQure system significantly lowered the blood pressure of the patients with no adverse events during and post treatment, stated DeepQure.