Delcath System for Isolated Liver Chemo

Delcath Systems, Inc. (Stamford, Conn.) is reporting that its proprietary system for the treatment of metastatic melanoma in the liver has successfully completed the Special Protocol Assessment and Agreement (SPA) with the FDA. As a result of this action, active patient enrollment for Delcath’s Phase III clinical trial at the National Cancer Institute (NCI) is expected to begin immediately, according to the company.
Delcath’s interesting system is based on core double balloon catheter technology–percutaneously and angiographically delivered– to selectively infuse high-dose chemotherapy directly to the liver via the hepatic artery catheter. As blood exits the liver into the inferior vena cava (IVC), it cannot flow back to the body as the IVC is blocked by double balloons above and below the liver, courtesy of the second catheter. Blood is diverted into a special Delcath filter system that collects the chemotherapy, thus protecting the rest of the body. The company believes that such a procedure is “repeatable and is less invasive than traditional surgical ways of performing isolated perfusion to effect dose-directed therapy for specific body organs or regions.”
To see how the system works, go the technology page at Delcath…
The press release…