About the Technology
How Does the Technology Work?
Liver-directed high dose chemotherapy via percutaneous hepatic perfusion involves three basic steps: 1) Isolation2) Infusion and 3) Hemofiltration.
First, an infusion catheter is inserted into the femoral artery and guided so that the tip of the catheter is within the hepatic artery to deliver the anticancer drug, melphalan hydrochloride. Next, the Delcath isolation-aspiration catheter is inserted into the femoral vein and guided into the inferior vena cava. In the inferior vena cava, two occlusion balloons of the isolation-aspiration catheter are inflated to block the normal venous outflow of blood from the liver to the heart, thereby isolating the liver.
High doses of melphalan are delivered directly to the liver via the infusion catheter over a period of 30 minutes, saturating the liver and the tumor tissue.
The isolation-aspiration catheter collects the blood as it exits the liver in the region between the two inflated balloons and then directs it out of the body. The blood then passes through the Delcath proprietary hemofiltration system, which reduces the concentration of chemotherapeutic agent. The filtered blood can now be returned to the patient's body through a third catheter placed in the internal jugular vein.
Delcath has supported clinical research of liver directed high dose chemotherapy in patients with metastatic ocular and cutaneous melanoma, metastatic colorectal cancer, metastatic neuroendocrine tumors and hepatocellular carcinoma.
In the United States, Delcath’s system for liver-directed high dose chemotherapy is an investigational product and is not approved by the U.S. Food and Drug Administration.