March 8, 2017—Washington, DC—Surefire Medical, Inc. today announced that clinical data presented at the Society for Interventional Radiology (SIR) Annual Scientific Meeting in Washington, DC showed in a retrospective case-controlled comparison that the use of Surefire infusion technology achieved a 79 percent objective response rate in the treatment of primary liver cancer (hepatocellular carcinoma or HCC) in transarterial chemoembolization procedures (TACE) versus 37 percent with a standard microcatheter.
The research review was conducted by Alexander Y. Kim, MD, assistant professor of radiology at Georgetown University Medical Center (GUMC) with patient records from GUMC’s clinical partner, MedStar Georgetown University Hospital. The case-control study was performed on a total of 38 patients with 19 patients in each arm. Selection of patients included in the study was based on similar tumor size, location, laterality, Child-Pugh score (a system used measure the severity of chronic liver disease), and underlying etiology of HCC.
According to the published abstract, “In our case-control series, patients undergoing TACE with SIS (Surefire Infusion System) demonstrated a statistically significant improvement in disease response rate compared to those undergoing treatment with a standard end-hole microcatheter.”1
In a previously published clinical trial, the Surefire Infusion System increased tumor uptake by 68 percent and reduced treatment delivered to healthy tissue by 58 percent when compared to a standard microcatheter in treatment of multiple cancers of the liver.2 Additional clinical research conducted by Georgetown showed the Surefire technology effectively delivered therapy in the treatment of HCC with an 80 percent complete tumor response and 93 percent objective tumor response.3
“This case-controlled study supports the growing body of evidence that the use of Surefire technology to treat primary liver cancer can achieve higher objective response rates,” said James E. Chomas, President and CEO of Surefire Medical. “We are committed to providing Interventional Radiologist the tools to deliver therapies to patients that are highly targeted and effective as well as and provide protection of the healthy tissue.”
A prospective, comparative evaluation is now underway to validate the preliminary findings.
1 The preliminary data presented in abstract form at the SIR 2017 meeting have not be peer-reviewed for publication. (Kim is a paid consultant for Surefire Medical).
2 A. Pasciak, et al. “The Impact of an Antireflux Catheter on Target Volume Particle Distribution in Liver-Directed Embolotherapy: A Pilot Study”, J Vasc Interv Radiol 2015; 26:660–669.
3 Kim, et al. “Single Center Experience with the Surefire Infusion System for Delivery of DEB-TACE in Treatment of HCC,” Presented at the 2016 Society of Interventional Radiology Annual Scientific Conference, 4/5/2016, Vancouver Convention Centre.
About Surefire Medical
Surefire Medical, Inc. develops, manufactures and markets targeted delivery devices for the Interventional Oncology markets. Surefire’s core technology consists of a microcatheter with a unique expandable tip that improves tumor uptake while protecting healthy tissue. It enables physicians to target tumors with superior accuracy, control and protection. Learn more: www.surefiremedical.com.
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