Delcath Systems of New York, NY received European CE Mark approval for use of its CHEMOSAT system along with doxorubicin chemotherapy injections for the treatment of hepatocellular carcinoma. The CHEMOSAT system is used to isolate the liver, deliver a high dose of chemotherapy to the organ, and to then filter out much of the chemotherapeutic agent before it gets to the rest of the body.
Although the new regulatory approval is meant to provide the company access to the European market, Delcath is planning to initially take advantage of Asian markets that recognize the CE Mark.
More details about the worksings of CHEMOSAT from Delcath’s technology page:
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.
Flashback: Delcath System for Chemosaturation Therapy Gets European OK
Press release: DELCATH ANNOUNCES CE MARKING FOR HEPATIC CHEMOSAT® DELIVERY SYSTEM FOR USE WITH DOXORUBICIN INJECTION
(hat tip: MassDevice)
