Delcath Systems, Inc.
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Model HEPZATO KIT - Melphalan Hydrochloride for Injection/Hepatic Delivery System

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Delcath has developed a percutaneous targeted, whole-organ treatment that delivers a select high-dose chemotherapy agent directly to the liver, while controlling systemic side effects, by filtering the chemotherapeutic agent from the blood before returning it to the patient. In the US, our drug/device investigational product is HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system). HEPZATO™ has not been approved by the U.S. Food & Drug Administration. It is under evaluation in a global registration trial (FOCUS Trial)  for treatment of patients with hepatic dominant ocular melanoma. In Europe our product is sold under the trade name CHEMOSAT® Hepatic Delivery System (“CHEMOSAT”). CHEMOSAT was CE Marked in 2012, to treat patients with cancers of the liver. 

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The CHEMOSAT medical device is now available at many of Europe’s leading oncology centers, with over 1,000 treatments conducted to date.

About PHP

Liver-directed high dose chemotherapy evolved from a highly invasive open surgical procedure to a minimally invasive procedure known as percutaneous hepatic perfusion (PHP). During PHP, three catheters are placed percutaneously through standard interventional radiology techniques. The liver is temporarily isolated from the body’s circulatory system, during which time a 30 minute infusion of the chemotherapeutic agent melphalan hydrochloride directly to the liver occurs. The blood is collected as it exits the liver for filtration by proprietary filters prior to returning it to the patient.

In the United States, Delcath’s system for PHP has been evaluated in a Phase 3 trial for patients with unresectable ocular and cutaneous liver metastases. Additional cancers including colorectal cancer, neuroendocrine tumors and in patients with hepatocellular carcinoma (primary liver cancer) have been studied.