Orlando, FL 4/5/12 (StreetBeat) -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced that the Company has received CE Mark approval for the second generation hemofiltration cartridge of the Company's proprietary Hepatic CHEMOSAT® Delivery System. With the new hemofiltration cartridge, 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 (melphalan hydrochloride) to the liver to any patient who in their opinion may benefit.
"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," said Eamonn P. Hobbs, President & CEO of Delcath Systems. "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. We look forward to the first European commercial procedure using the new filter, which is scheduled for next week," Mr. Hobbs added.
CE Marking confirms that a medical device complies with the Essential Requirements of the Medical Device Directive, and that the device has been subjected to conformity assessment procedures. Receipt of the CE Mark allows Delcath to market and sell its Class III medical device in countries in the European Economic Area (EEA). Delcath's new hemofiltration cartridge's design and technology is patent pending.
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