{"id":3930,"date":"2024-06-10T13:00:04","date_gmt":"2024-06-10T06:00:04","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=3930"},"modified":"2024-06-10T13:00:04","modified_gmt":"2024-06-10T06:00:04","slug":"deepqure-receives-ide-approval-from-fda-for-its-efs-study-to-treat-resistant-hypertension-with-its-extravascular-renal-denervation-technology-hyperqure","status":"publish","type":"post","link":"https:\/\/thaipropertynews.com\/feeds\/?p=3930","title":{"rendered":"DeepQure receives IDE Approval from FDA for its EFS study to treat Resistant Hypertension with its Extravascular Renal Denervation Technology (HyperQure\u2122)"},"content":{"rendered":"

SEOUL, South Korea<\/span><\/span>, June 10, 2024<\/span><\/span> \/PRNewswire\/ — DeepQure, a Seoul<\/span> 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\u2122 system following FDA IDE approval. HyperQure\u2122 is the world’s first extravascular RDN medical device for the treatment of resistant hypertension.<\/p>\n

With this approval, the company will commence the Early Feasibility Study to prove the safety and efficacy of HyperQure\u2122 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<\/span>, Mayo Clinic, Emory University<\/span>, University of Arizona<\/span> and the University of California, Irvine<\/span>.<\/p>\n

“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.\u00a0 We will accelerate our global clinical trials with this IDE approval,” says Chang Wook Jeong, co-founder and CMO of DeepQure Inc.<\/p>\n

HyperQure\u2122 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.\u00a0 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\u00a0HyperQure 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<\/a>.\u00a0\u00a0<\/p>\n

\n

<\/a>
DeepQure initiates Early Feasibility Study for the HyperQure, the world’s first extravascular RDN medical device for the treatment of resistant hypertension.<\/span><\/p>\n<\/div>\n

https:\/\/youtu.be\/8YtZZ9knSB4<\/a><\/p>\n

The Korean First in Human HyperQure\u2122 trial is on-going and initial results are showing strong symptomatic improvements in patients with resistant hypertension \u2013 these patients showed uncontrolled hypertension despite taking 5-8 hypertensive drugs. The\u00a0RDN treatment utilizing the HyperQure\u2122 system significantly lowered the blood pressure of the patients with no adverse events during and post treatment.\u00a0<\/p>\n

About DeepQure Inc.<\/p>\n

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:\/\/www.deepqure.com.<\/span><\/a><\/p>\n

Contacts:<\/p>\n

GeunWoo Noh<\/p>\n

gwnoh@deepqure.com<\/a>\u00a0<\/p>\n

<\/div>","protected":false},"excerpt":{"rendered":"

<\/p>\n

SEOUL, South Korea<\/span><\/span>, June 10, 2024<\/span><\/span> \/PRNewswire\/ — DeepQure, a Seoul<\/span> 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\u2122 system following FDA IDE approval. HyperQure\u2122 is the world’s first extravascular RDN medical device for the treatment of resistant hypertension.<\/p>\n

With this approval, the company will commence the Early Feasibility Study to prove the safety and efficacy of HyperQure\u2122 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<\/span>, Mayo Clinic, Emory University<\/span>, University of Arizona<\/span> and the University of California, Irvine<\/span>.<\/p>\n

“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.\u00a0 We will accelerate our global clinical trials with this IDE approval,” says Chang Wook Jeong, co-founder and CMO of DeepQure Inc.<\/p>\n

HyperQure\u2122 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.\u00a0 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\u00a0HyperQure 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<\/a>.\u00a0\u00a0<\/p>\n

\n

<\/a>
DeepQure initiates Early Feasibility Study for the HyperQure, the world’s first extravascular RDN medical device for the treatment of resistant hypertension.<\/span><\/p>\n<\/div>\n

https:\/\/youtu.be\/8YtZZ9knSB4<\/a><\/p>\n

The Korean First in Human HyperQure\u2122 trial is on-going and initial results are showing strong symptomatic improvements in patients with resistant hypertension \u2013 these patients showed uncontrolled hypertension despite taking 5-8 hypertensive drugs. The\u00a0RDN treatment utilizing the HyperQure\u2122 system significantly lowered the blood pressure of the patients with no adverse events during and post treatment.\u00a0<\/p>\n

About DeepQure Inc.<\/p>\n

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:\/\/www.deepqure.com.<\/span><\/a><\/p>\n

Contacts:<\/p>\n

GeunWoo Noh<\/p>\n

gwnoh@deepqure.com<\/a>\u00a0<\/p>\n

<\/div>\n

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