Delcath Systems announced that the company has received European regulatory approval via the CE Mark for their second generation hemofiltration cartridge, which is used in Delcath’s Hepatic CHEMOSAT Delivery System. The CE Mark means that Delcath will be allowed to market its Class III medical device in countries in the European Economic Area (EEA).
Delcath is focused on oncology, in terms of specialty pharmaceuticals and medical devices. The company’s proprietary system for chemosaturation is designed to administer high-dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. Delcath’s Hepatic CHEMOSAT received the CE Mark in April of 2011. Delcath is currently undergoing the process to submit its system for approval in the United States’ FDA.
The new CHEMOSAT system will allow physicians to use the system for the percutaneous intra-arterial administration of a chemotherapeutic agent to the liver of cancer patients. The new hemofiltration cartridge will still allow the CHEMOSAT system to carry the same broad indication as the last generation system.
Eamonn P. Hobbs, president & CEO of Delcath Systems, said, “With receipt of CE Mark for our second generation CHEMOSAT system, we will now be able to supply centers in Europe with a product that we believe offers improved filtration efficiency compared to the previous generation filter used in our clinical trials. The new hemofiltration cartridge has demonstrated melphalan removal of greater than 98% during drug infusion in an in vivo study.Additionally the new filter removed significantly fewer blood platelets in the same study.”
“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,” Hobbs added. “We look forward to the first European commercial procedure using the new filter, which is scheduled for next week.”
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