Medical device company DeepQure has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for an early feasibility study (EFS) of its HyperQure system.
Seoul-based DeepQure has designed HyperQure to treat resistant hypertension.
HyperQure is an extravascular (laparoscopic approach) renal denervation (RDN) medical device.
Following the IDE approval, the South Korean firm will now start the early feasibility study aimed at demonstrating the safety and effectiveness of HyperQure in 15 patients with resistant hypertension.
This clinical trial will adopt a prospective, multicentre, single-arm, open-label design and will take place at US university hospitals such as Stanford University, Mayo Clinic, University of Arizona, Emory University, and University of California, Irvine.
DeepQure co-founder and chief marketing officer Chang Wook Jeong said: “This is a significant US regulatory milestone for DeepQure, starting the feasibility study using the extravascular ablation platform in the US for the Renal Denervation indication.
“We will accelerate our global clinical trials with this IDE approval.”
The HyperQure system comprises an energy generator and a laparoscopic instrument designed to deliver radio frequency (RF) energy for ablation directly to the sympathetic nerves surrounding the renal artery.
By surrounding the renal artery 360 degrees from its exterior, the system enables complete denervation of renal sympathetic nerves without causing damage to the vascular endothelium.
DeepQure said the HyperQure system is a simple, straightforward, user-friendly device. It aims to ensure uniform denervation results irrespective of the surgeon’s expertise.
Initial results from an ongoing Korean First in Human HyperQure trial is said to have shown strong symptomatic improvements in patients suffering from resistant hypertension. These individuals remained hypertensive despite being prescribed five to eight hypertensive medications.
The RDN treatment, employing the HyperQure system, considerably reduced the blood pressure of patients without any adverse events occurring during or after the treatment, said the South Korean company.
DeepQure is also planning to expand the technology to treat other cardiovascular diseases like pulmonary hypertension, atrial fibrillation, and ventricular tachycardia.
