UK-based pharmaceuticals company BTG has secured the CE mark granted by the Notified Body British Standards Institution (BSI) after the reclassification of DC Bead and DC BeadM1 as Class III medical devices.

Both DC Bead and DC Bead M1 have been developed as embolic agents to treat malignant hypervascularised tumours.

BTG interventional oncology chief technology officer Russell Hagan said: "We are delighted to receive the Class III CE Mark approval for DC Bead and DC BeadM1 .

"Their ability to administer medicines in a controlled and sustained manner after chemoembolisation is widely documented and their clinical use and patient benefits are supported by extensive product-specific clinical data."

"Their ability to administer medicines in a controlled and sustained manner after chemoembolisation is widely documented and their clinical use and patient benefits are supported by extensive product-specific clinical data generated by BTG and the healthcare professionals we support.”

The evaluation of the devices has considered their ability in delivering the medicine and was supported by product-specific non-clinical and clinical data validating the safety and efficacy of the usage of DC Bead and DC Bead M1.

The devices are drug-eluting bead which can load and release chemotherapeutic agents in a controlled fashion.

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DC Bead is used in trans-arterial chemoembolisation (TACE), which is a minimally invasive non-surgical procedure conducted by an interventional radiologist.

It has been produced from a biocompatible polyvinyl alcohol (PVA) hydrogel which has been modified with sulphonate groups enabling the controlled loading and delivery of the drugs.

DC Bead and DC Bead M1 release DEBDOX to block vessels housing malignant hypervascularised tumours and can  release irinotecan to block vessels supplying malignant colorectal cancer metastasised to the liver (mCRC).