DeepQure, a Seoul based medical device
company with a novel, extravascular (laparoscopic approach) solution for renal
denervation (RDN), today announced initiation of its Early Feasibility Study
(EFS) for the HyperQure™ system following FDA IDE approval. HyperQure™ is the world's first extravascular
RDN medical device for the treatment of resistant hypertension.
With this approval, the company will commence
the Early Feasibility Study to prove 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 major U.S.
university hospitals, including Stanford University, Mayo Clinic, Emory
University, University of Arizona and the University of California, Irvine.
"We are thrilled that the FDA has
approved our IDE study plan. This is a significant US regulatory milestone for
DeepQure Inc., 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," says Chang Wook Jeong, co-founder and CMO of
DeepQure Inc.
HyperQure™ system consists of an energy generator
and a laparoscopic instrument that delivers RF energy for ablation directly to
the sympathetic nerves around the renal artery by wrapping the renal artery 360
degrees from outside of the vessel. This
mechanism allows full denervation of renal sympathetic nerves without damaging
the vascular endothelium which has proven to be a challenge for intravascular (catheter)
systems. The HyperQure system is a
simple, straightforward device that is easy to learn and aims to deliver
uniform denervation results regardless
of the surgeon’s skill sets.
The Korean First in Human HyperQure™ trial is
on-going and initial results are showing strong symptomatic improvements in
patients with resistant hypertension – these patients showed uncontrolled
hypertension despite taking 5-8 hypertensive drugs. The RDN treatment utilizing the HyperQure™
system significantly lowered the blood pressure of the patients with no adverse
events during and post treatment.
About DeepQure Inc.
DeepQure Inc., is a clinical stage medical
device company focused on the development of a novel, extravascular (laparoscopic
approach) device for the treatment of hypertension. Company is undergoing R&D to expand the technology
to treat other cardiovascular diseases such as Atrial Fibrillation, Pulmonary
Hypertension and Ventricular Tachycardia.
For more information please visit
https://(deepqure.com)
(Source: PR Newswire)
