• 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 » Shockwave wins CE Mark for coronary Lithoplasty device

Shockwave wins CE Mark for coronary Lithoplasty device

May 15, 2017 By Sarah Faulkner

Shockwave MedicalShockwave Medical said today that it won CE Mark approval in the European Union for its coronary Lithoplasty system. The therapy is designed to treat calcified coronary artery blockages with lithotripsy – sonic pressure waves that are traditionally used to treat patients with kidney stones.

The approval was supported by clinical data from the Disrupt CAD I study, which evaluated the system’s efficacy as a treatment for calcified coronary arteries prior to drug-eluting stent implantation.

“Cardiovascular calcification presents a persistent treatment challenge for the interventionalist,” co-principal investigator Dr. Jean Fajadet said in prepared remarks. “The use of Lithoplasty in the coronary arteries is an important new option that has shown, in the Disrupt CAD I clinical study of the device, to effectively prepare the vessel for stent implantation with minimal complications. I look forward to commercial availability of the system.”

“CE Mark for the Coronary Lithoplasty System is an important milestone for Shockwave Medical,” CEO Doug Godshall added. “With this achievement, we are a step closer to bringing Lithoplasty to patients and physicians in Europe as a potentially paradigm-changing technology for the treatment of coronary artery disease. We look forward to sharing our final 6-month results from Disrupt CAD I at EuroPCR this week, and to continuing to gather clinical evidence on the benefits of this promising treatment for a challenging patient population.”

Filed Under: Cardiovascular, Regulatory/Compliance, Vascular, Wall Street Beat Tagged With: Shockwave Medical

More recent news

  • Neuralink files to raise $649M in new equity offering
  • BofA: Surgical robot remanufacturing not a major setback for Intuitive
  • InspireMD wins CE Mark approval for CGuard Prime
  • Philips reports first cases for VeriSight Pro 3D ICE catheter in Europe
  • Ceryx Medical raises $15M to support bioelectronic pacemaker

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