Abstract
Convection-enhanced delivery is an experimental method for glioblastoma treatment. This work evaluates the Convection-Enhanced Therapy Catheter System (CETCS) by subjecting it to several cadaveric fetal bovine and porcine brain tests that replicate the anticipated future clinical use of the device.
CETCS includes a cannula containing six microneedles. First, the CETCS cannula and microneedle visibility were evaluated with CT imaging in cadaveric tissue. Second, the cannula and microneedles were subjected to a cadaveric tissue insertion test and evaluated for tissue accumulation postinsertion. This test was also performed with a silicone elastomer material similar to a predicate device. A third test evaluated the microneedle's ability to undergo a syringe drop test with 3, 10, and 20 mL water-filled syringes.
The results of this study prove that the CETCS cannula and microneedles are visible with CT imaging. CETCS and the predicate device material for the tissue insertion tests behave similarly, with an average tissue accumulation mass of 16.4 ± 3.6 mg and 21.4 ± 4.0 mg, respectively. The microneedles did not experience function-limiting damage with any attached syringes in the syringe drop test. The passing of all tests suggests that CETCS will satisfactorily meet regulatory testing milestones required for future clinical use.
