Friday June 9, 2017 0 comments
WESTMINSTER -- Surefire Medical, developer of site-specific delivery devices for the interventional oncology market, announced results from a retrospective analysis of 85 bridge-to-transplant liver cancer patients treated with transarterial chemoembolization (DEB-TACE).
Surefire said the analysis showed therapy delivery with the company’s Surefire Infusion System was associated with an 80 percent complete response in one treatment versus 52 percent with a standard endhole microcatheter.
In addition, Surefire said the analysis shows a statistically significant lower recurrence rate of liver cancer at one month of 13 percent using Surefire technology versus 52 percent recurrence with a standard microcatheter.
All patients were diagnosed with hepatocellular carcinoma (HCC) and were eligible for a liver transplant, Surefire said.
In a subanalysis cohort, 23 patients received a transplant with five patients treated using a Surefire device while 18 were treated using a standard microcatheter. Pathological review of explanted livers demonstrated that the use of Surefire technology improved tumor uptake, with 89 percent of the chemo beads delivered to the tumor in the Surefire procedures versus 55 percent in standard microcatheter procedures.
Further pathological review showed a consistently high mean percentage of tumor necrosis for Surefire procedures of 89 percent versus 56 percent in standard microcatheter procedures, the company said.
"This study of bridge-to-transplant patients with HCC provides further evidence to suggest that Surefire may be a more effective tool to downstage patients for transplant when compared with a standard endhole microcatheter," said Lance Stein, transplant hepatologist, Piedmont Transplant Institute.
"As evidenced in this and previous clinical studies, the use of Surefire technology in embolization procedures optimizes penetration of therapy in tumors, which potentially increases complete response rates and spares healthy tissue.
“The data also showed consistently high tumor necrosis was achieved with the Surefire."
In addition to this study, recently presented at the 2017 American Transplant Congress, Surefire Medical said it has five clinical studies currently underway. Chief among the Surefire studies is a multi-center randomized controlled study comparing tumor response and medical outcomes for HCC patients who undergo DEB-TACE with Surefire versus a standard microcatheter.
Full details can be found at ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show/NCT02748161.