DeepQure wins FDA IDE nod for renal denervation study

DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study […]

DeepQure announced today that it received FDA investigational device exemption (IDE) approval for a study of its HyperQure system.

The Seoul, South Korea-based company designed HyperQure to perform renal denervation (RDN) through an extravascular (laparoscopic) approach. DeepQure says it’s the world’s first extravascular RDN medical device for treating resistant hypertension.

RDN for hypertension became a hot topic in medtech over the past few years, with several big names developing their own technology. Recor Medical became the first company to win FDA approval for RDN for hypertension back in November 2023. Medtronic received approval for its Symplicity Spyral system just weeks later.

Their technologies treat hypertension in different ways, while both using catheters. Recor’s Paradise system uses two to three doses of 360-degree ultrasound energy, lasting seven seconds each. The energy travels through each of the main renal arteries to the surrounding nerves. Medtronic’s platform delivers radiofrequency (RF) energy to nerves near kidneys in a minimally invasive procedure.

DeepQure, meanwhile, uses an energy generator and a laparoscopic instrument that delivers RF energy for ablation directly to the sympathetic nerves around the renal artery. It wraps the renal artery 360 degrees from outside the vessel, allowing for full denervation of the renal sympathetic nerves. This keeps from damaging the vascular endothelium, a challenge for intravascular (catheter) systems.

FDA IDE approval allows the company to begin an early feasibility study in the U.S. in 15 patients with resistant hypertension.

“This is a significant US regulatory milestone for DeepQure, starting the feasibility study using the extravascular ablation platform in the U.S. for the renal denervation indication,” said Chang Wook Jeong, DeepQure co-founder and chief medical officer.  We will accelerate our global clinical trials with this IDE approval.”

Original Article (https://www.massdevice.com/deepqure-wins-fda-ide-nod-for-renal-denervation-study/)