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DeepQure receives IDE approval from FDA for its EFS study

DeepQure 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.
MB Bureau

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