FONT-SIZE Plus   Neg

Delcath Says Hemofiltration Cartridge Gets CE Mark Approval

Oncology-based pharma and medical device company Delcath Systems, Inc. (DCTH) announced the receipt of CE Mark approval for the second-generation hemofiltration cartridge of its proprietary Hepatic CHEMOSAT Delivery System, allowing the company to now supply second-generation CHEMOSAT system to centers in Europe.

With the new hemofiltration cartridge, the company said, the CHEMOSAT system carries the same broad indication as the previous generation system, permitting physicians to use the product for the percutaneous intra-arterial administration of a chemotherapeutic agent to the liver to any patient who in their opinion may benefit.

"With the new hemofiltration cartridge, we believe that CHEMOSAT may help to improve the management of side effects on treated patients and potentially complement other systemic cancer therapies, leading to greater system utilization. We look forward to the first European commercial procedure using the new filter, which is scheduled for next week," Eamonn Hobbs, President & CEO of Delcath Systems said in a statement.

The approval from CE Mark allows Delcath to market and sell its Class III medical device in countries in the European Economic Area, or EEA. Delcath's new hemofiltration cartridge's design and technology is patent pending.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Large U.S. companies are holding trillions of dollars overseas in an effort to avoid U.S. taxes, with big-name firms like Apple (AAPL), Pfizer (PFE) and PepsiCo (PEP) named as notable examples. This is the claim made by a pair of non-profit groups, who released a study based on the firms' financial statements. The European Investment Bank or EIB will be examining whether the German auto giant Volkswagen utilized loans from any of the European Union countries to develop the illegal software to evade emissions. If the car maker is a culprit, the Bank will take actions to get back the loan. Mainland reinsurer China Re is set out to reinvigorate the Asian IPO market that went into a lull following the recent market volatility. The reinsurer, which boasts of having 93 percent of the domestic insurers as its clients, is set to list its shares in the Hong Kong market.
comments powered by Disqus
Trade DCTH now with 
Follow RTT