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.
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