Live Breaking News & Updates on Therapeutic Intra Vascular Ultrasound System

TEL AVIV, Israel, June 20, 2022 /PRNewswire/ SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound System (TIVUS) to treat a variety of hypertensive disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration granted IDE approval for its "REDUCED1" Pilot study to treat Resistant Hypertension Patients with Renal Artery Denervation using TIVUS, its innovative Ultra-Sound Ablation System. Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure. "We are very pleased that FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study.Sites initiation has started,and many clinical teams ....

United States , Tomaso Zambelli , Christian Spaulding , Sonivie Ltd , Drug Administration , Therapeutic Intra Vascular Ultrasound System , Resistant Hypertension Patients , Renal Artery Denervation , Ultra Sound Ablation , Renal Denervation , Ultrasonic Catheter Emitted , Ultra Sound Denervation , Tel Aviv , June 20 , 022 Prnewswire Sonivie , N Israeli Company Developinga Novel Proprietary Therapeutic Intra Vascular Ultrasound System Tivus To Treata Variety Of Hypertensive Disorders , Nnounced That On May 5th 2022 The Us Food And Drug Administration Granted Ide Approval For Its Quot Reduced1 Pilot Study To Treat Resistant Hypertension Patients With Renal Artery Denervation Using Tivus , Ts Innovative Ultra Sound Ablation System Resistant Hypertension Is Defined As Blood Pressure Higher Than 140 90 Mmhg Despite Use Of Three Antihypertensive Medications Different Classes At The Best Tolerated Doses , Ne Of Which Must Bea Diuretic Millions People World Wide Suffer From Resistant Hypertension Substantially Increases The Risk Heart Attack , Troke And Kidney Failure Quot We Are Very Pleased That Fda Has Approved The Reduced1 Renal Denervation Using Ultrasonic Catheter Emitted Energy Study Sites Initiation Started , And Many Clinical Teams Have Responded Very Favourably About Participating To The Study There Isa Significant Number Of Patients That May Benefit From Our Technology We Are Genuinely Happy For This Important Step Towards Introduction Tivus In Us Lack Effective Therapeutic Solutions Suffering Resistant Hypertension , Nd Physicians Are Looking Forward Toa Safe , Ffective And Easy To Use Device Treatment , Uot Says Christian Spaulding , Onivie Ltd Quot This Isa Significant Us Regulatory Milestone For Sonivie , Tarting The Feasibility Study Using Ultra Sound Ablation Platform In Us For Renal Denervation Indication This Isa Major Step And Priority Company 39s History ,