• 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 » Balt wins CE Mark for Titan aspiration catheter

Balt wins CE Mark for Titan aspiration catheter

May 14, 2019 By Brad Perriello

BaltBalt said yesterday that it won CE Mark approval in the European Union for the Titan aspiration catheter.

The catheter dates back to the September 2016 acquisition of endovascular device developer Blockade Medical and its Barricade coil. Blockade’s facility in Irvine, Calif., became the headquarters for Balt’s new American subsidiary, with Blockade co-founder, president & CTO David Ferrera as president & COO and Balt International CEO Pascal Girin as chief executive.

“Obtaining the CE mark for Titan strengthens Balt’s position in the rapidly growing ischemic stroke market,” Girin said in prepared remarks. “Titan marks the sixth significant product approval obtained by Balt within the last year and is a testament to Balt’s commitment to bring a rapid succession of innovative products to the neurovascular community.”

The Titan catheter is the subject of a bitter legal dispute with the spinout, Neurvana Medical, that was formed to continue developing three devices that weren’t part of the deal for Blockade. In January Neurvana sued its parent, accusing Balt of reneging on a $16 million deal for Titan in a scheme to “sabotage and destroy” Neurvana.

Last month Balt moved to dismiss the case, arguing that Neurvana failed to include the oral promises made by Balt in the contract it eventually signed.

“Instead, after Neurvana’s attempts at European regulatory approval for Titan failed, the parties agreed in the [contract] and a subsequent amendment that [Balt] would use contractually-defined ‘commercially reasonable efforts’ to obtain that approval – while Neurvana would retain the responsibility for securing regulatory approval in the U.S.,” Balt argued in the April 1 brief. “[Balt’s] efforts to obtain European regulatory approval are ongoing, despite facing challenges with a necessary sterilization process for Titan. Neurvana has since given up on its own efforts in the U.S. Nevertheless, plaintiff now claims that [Balt] is responsible for alleged damages caused by the fact that Titan has not been approved for use anywhere, and thus cannot be commercialized.”

In a May 7 answering brief, Neurvana said Balt’s “kitchen-sink motion to dismiss” every claim “is not credible.”

“In their motion, defendants regularly misstate the applicable legal standards, ignore the well-pleaded allegations in the complaint, and ask the court to make factual determinations that are inappropriate on a motion to dismiss,” according to the Neurvana answering brief. “In short, Neurvana has sufficiently alleged that it has been wronged under numerous legal theories. Discovery likely will reveal many more instances of breach and bad faith by defendants that currently are known only to them, including additional actions to sabotage the [contract] and Neurvana.”

Filed Under: Catheters, Featured, Legal News, Regulatory/Compliance Tagged With: Balt, Neurvana Medical, Stroke

More recent news

  • GE HealthCare expands digital imaging portfolio with enhanced MIM Encore software
  • Accelus wins FDA clearance for MRI compatibility of FlareHawk spinal implants
  • Presidio wins FDA IDE for ultra-low frequency neuromod, hires new CFO
  • Epiminder study backs implantable EEG tech
  • Neurent Medical wins FDA nod for next-gen chronic rhinitis treatment

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