The Therapeutic Goods Administration (TGA), a division of Australian government, has granted approval to Delcath Systems' Hepatic Chemosat delivery system.
Delcath’s delivery system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents.
Delcath Systems president and CEO Eamonn Hobbs said they believe chemosaturation therapy via their Chemosat system will provide an important treatment alternative for liver cancer patients in the Australian market.
The company has received CE mark for its Chemosat system in April 2011 and has completed the product notification process with the Medicines and Medical Device Safety Authority in New Zealand in October 2011.