About the Technology
How Does the Technology Work?
Chemosaturation therapy via percutaneous hepatic perfusion involves three basic steps: 1) Isolation;2) Saturation; and 3) Filtration.
1. Isolation
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.
2. Saturation
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.
3. Filtration
The isolation-aspiration catheter collects the drug-laden 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 filtration 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.
The Potential of This Technology
We believe chemosaturation therapy may have potential application for a range of cancers in the liver, such as colon cancer, breast cancer, and melanoma, as well as others.
Chemosaturation therapy has the potential for clinically meaningful tumor reduction. Nevertheless, as with most medical procedures and cancer medications, there are certain inherent risks related to the placement of catheters and/or toxicities from systemic exposure to residual drug in the bloodstream.
Our proprietary Hepatic CHEMOSAT® Delivery System has obtained CE Mark approval in Europe for administration of melphalan hydrochloride to the liver. In the United States, Delcath’s system for chemosaturation is an investigational product and is not approved by the U.S. Food and Drug Administration.
Clinical History
Delcath has supported clinical research of hepatic chemosaturation therapy in patients with liver cancer.