Surefire system vs. end hole catheter clinical trial eliminates patient variables


Preliminary observations from the trial were presented at the Global Embolization Symposium and Technologies US (GEST US meeting, 1–4 May, San Francisco, USA) and show increased tumour penetration with the Surefire system.

­­Data from the University of Tennessee Medical Center prospective study that uses a new dual step infusion technique to compare biodistribution after the Surefire Infusion System and after use of a conventional end hole catheter were presented.

In the study, patients underwent two infusion procedures on the same day in order to eliminate sources of uncertainty other than the type of catheter used. Particle uptake and distribution were assessed with SPECT imaging after each procedure.

“Nuclear imaging is more quantifiable than other imaging techniques,” said study author Alexander Pasciak.  “The observations are preliminary but in the first five patients, nuclear imaging shows greater penetration and decreased non-target embolization using the Surefire Infusion System.”

Tumour penetration is also assessed on the day of radioembolization therapy.  Bremsstrahlung SPECT and 90Y PET/CT scans show particle distribution with the Surefire system closely matched pretreatment planning intentions.

The latest clinical evidence builds on previous research showing that the Surefire’s unique, pliable expanding tip controls downstream hepatic arterial blood pressure changes that potentially increase tumour uptake of embolization agents.

“This trial is exciting because it directly compares infusion systems in the same patient, same disease and same day. Early data suggests the choice of infusion system plays a big role in dose delivered into a tumour,” says Surefire president and CEO Jim Chomas.  “The possibility of potentially greater tumour penetration, with its implications for increasing efficiency and reducing costs of embolization procedures, continues to build the case for preferential use of the novel Surefire Infusion System,” he said.