US-based developer of cancer-drug delivery catheters Surefire Medical has completed enrolment in COSY, the randomised prospective study designed to determine the safest method of radioembolisation using the new anti-reflux Surefire Infusion System.
The new anti-reflux infusion system, a first-in-class medical device, is designed to maximise direct-to-tumour delivery of cancer-fighting agents and eliminate reflux.
Coiling vs Surefire Infusion System in Y90 (COSY) clinical trial investigates the feasibility and benefits of performing selective internal radiation therapy (SIRT), or radioembolisation, without the need to place permanent coils.
In SIRT treatment and in chemoembolisation with drug-eluting beads, the unique tip dynamically expands to the vessel walls in reverse flow, which is essential in reducing reflux of diagnostic and therapeutic agents to non-target vessels and minimising potential damage to healthy tissue.
SIRT is a form of radiation therapy generally used for selected patients with hepatic cell carcinoma or liver metastasis.
According to the company, half of patients will have permanent embolic coils placed, while the other half will undergo treatment with the Surefire Infusion System without coiling in the trial.
The study’s primary endpoint is fluoroscopy time, while the secondary endpoints are procedure time, radiation dose and contrast dose.
Around 30 patients have been enrolled at Mount Sinai Hospital in NYC and the principal investigators of the study are Drs Aaron Fischman and Rahul Patel.
Surefire Medical scientific advisory board chief scientific officer and chairman Dr Aravind Arepally said clinical studies show that SIRT can increase the overall survival without adversely affecting the patient’s quality of life.
"The goal of this study is to see if this complex, cumbersome workflow can be significantly improved by reducing procedure time and if radiation exposure to both the physician and patient can also be reduced," Dr Arepally said.
According to GlobalData estimates, the infusion systems market in the US was valued at $2.68bn in 2012 and is expected to grow at a CAGR of 3.5% to reach $3.41bn by 2019.