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

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » SoniVie wins FDA breakthrough device designation for pulmonary hypertension device

SoniVie wins FDA breakthrough device designation for pulmonary hypertension device

September 9, 2019 By Danielle Kirsh

sonivie-logoSoniVie last week won FDA breakthrough device designation for its Therapeutic Intra-Vascular Ultrasound System for patients with pulmonary arterial hypertension.

The Therapeutic Intra-Vascular Ultrasound (TIVUS) System is a dedicated therapeutic ultrasound catheter that enhances the treatment of PAH, according to the company. It is inserted into the pulmonary artery during right heart catheterization and is designed to ablate nerves associated with PAH without damaging vessel walls and tissues.

“The TIVUS System qualifies as a breakthrough device because it is the first of any potential therapeutic product for PAH to use high-frequency non-focused ultrasound and can address a significant unmet need in this patient population,” CEO Chuck Carignan said in a press release. “In addition to providing priority review for the TIVUS regulatory submission to the FDA, this breakthrough device designation will also provide reimbursement benefits under a new Centers for Medicare and Medicaid Services alternative new technology add-on payment once the system is commercially available. We believe that, if shown to be effective, these benefits will help PAH patients gain access to a treatment option that has the potential to improve outcomes for this life-threatening disease.”

Rosh-Haayin, Israel-based SoniVie plans to start a pivotal trial of the system in 2020.

“PAH is classified as a life-threatening or irreversibly debilitating disease because it is characterized by a progressive increase in pulmonary vascular resistance that leads to right-sided heart failure and death,” Dr. Lewis Rubin, professor of medicine at UC San Diego and Columbia University College of Physicians and Surgeons, said. “There are no approved medical device treatment options for PAH, only medications. The TIVUS System has been shown in early clinical studies to stabilize or improve pulmonary vascular resistance in PAH patients, suggesting that it could offer significant incremental benefits to a patient population that has a five-year mortality greater than 40%.”

Filed Under: Cardiovascular, Catheters, Food & Drug Administration (FDA), Ultrasound Tagged With: SoniVie

More recent news

  • GT Medical raises $53M to support brain tumor treatment
  • Imperative Care, Proximie partner to develop surgical robot to treat stroke
  • Carlsmed launches IPO roadshow
  • Varian introduces IntelliBlate for image-guided cancer therapy in Europe
  • Henry Schein CEO Stanley M. Bergman to retire

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · 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.

Privacy Policy