• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Medical Tubing and Extrusion

Medical tubing and extrusion technologies

  • Catheters
  • Components
    • Connectors
    • Needles and Injections
    • Seals
    • Tubing Components
  • Manufacturing
    • Coatings
    • Extrusions
    • Machining
    • Injection Molding
    • Insert molding
    • Tools
  • Materials
    • Advanced Materials
    • Silicone
  • Research & Development
  • Suppliers

SoniVie wins FDA breakthrough nod for renal denervation tech

December 14, 2020 By Sean Whooley

SoniVieSoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology.

Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial hypertension (PAH) in September 2019.

“We are excited about moving the Tivus system into therapeutic areas beyond PAH and believe that the technology has broad utility in a variety of serious health conditions,” SoniVie CEO Dr. Chuck Carignan said in a news release. “A growing body of clinical evidence suggests that our ultrasound-based denervation technology may provide clinical benefit in the treatment of diseases that lack optimal medical management, including resistant hypertension. We believe that the Tivus System can work synergistically with existing treatments to potentially improve clinical outcomes.”

Tel Aviv, Israel-based SoniVie additionally announced that it acquired the remaining intellectual property and other assets related to the Tivus system’s use from Cardiosonic, having previously licensed technology related to its use in the treatment of PAH.

“With breakthrough device designation in two indications and control of the intellectual property and other assets related to the use of the TIVUS System in multiple indications, we have a strong competitive advantage as we work to advance targeted denervation as a therapeutic approach that can provide best-in-class outcomes to patients,” Carignan added.

Filed Under: Catheters Tagged With: fda, SoniVie

Primary Sidebar

DeviceTalks Tuesdays

DeviceTalks Tuesdays
MDO ad

Stay Current

Need Medical Tubing news in a minute?
We Deliver!

Medical Tubing + Extrusion newsletter get you caught up on all the mission critical news you need in medical tubing. Sign up today.

Enews Sign up

Sponsored Content

A new way to access scientific papers?

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website

Footer

Inv Logo

MASSDEVICE MEDICAL NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech 100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Souring
R&D World

Medical Tubing & Extrusion

Subscribe to our e-newsletter
Advertise with us
About
Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our Device Talks Tuesdays Discussion
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS