• 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 » Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech

February 20, 2020 By Chris Newmarker

Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system.

FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication.

Cardiovalve touted that it is the first privately held company to have the FDA early feasability study approval for both TR and MR (tricuspid/mitral regurgitation) indications.

Cardiovalve has developed a transfemoral valve replacement system in which the valve mimics current surgical replacement solutions. It is able to fit both mitral and tricuspid indications. Cardiovalve officials say the system is able to cover 90% of the patient population with three approved valve sizes, using the same delivery system.

“I have previously successfully performed initial first-in-human cases with the Cardiovalve MR procedure. Now, the Cardiovalve system can be utilized in the tricuspid location with the same transcatheter procedure. In fact, the Tricuspid is simpler and faster and, therefore, I anticipate similar procedural success,”  Dr. Francesco Maisano, head of cardiovascular surgery at Zurich University Hospital in Switzerland, said in a news release.

Cardiovalve CEO Amir Gross praised FDA recognition of the potential benefits of the transcatheter tricuspid valve replacement system.

“We now have clinical data two years out that our implant is functioning as expected and the patient is improved clinically,” Gross said. “FDA’s ‘breakthrough’ designation validates and reaffirms our commitment to improving and extending the lives of millions of patients suffering from heart valve disease across the world.”

Filed Under: Cardiovascular, Catheters, Clinical Trials, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Replacement Heart Valves Tagged With: cardiovalve

More recent news

  • Omnipod 5 rollout for type 2 rolls on as Insulet pursues next-gen automation
  • Ancora Heart reaches enrollment milestone in pivotal heart failure device trial
  • PharmaSens, SiBionics innovatively combine tech in all-in-one insulin patch pump
  • Johnson & Johnson launches daily disposable multifocal toric contact lens
  • Study backs Biolinq intradermal sensor in muscle loss prevention during GLP-1 therapy

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email 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