Balt 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.”

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