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INCREASED MICROSPHERE TUMOR PENETRATION

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FIRST IN MAN EXPERIENCE WITH THE SUREFIRE INFUSION SYSTEM-A DEDICATED MICROCATHETER SYSTEM TO ELIMINATE REFLUX DURING EMBOLOTHERAPY

J. D. Louie, E. A. Wang, S. Broadwell, B. C. Wible, A. Arepally, C. Nutting, L. Bester, D. Y. Sze

Presented During: Interventional Oncology: Radioembolization II, Annual Scientific Meeting for Society of Interventional Radiology, 3/27/2012

Abstract No: 195

Institutions:  1. Interventional Radiology, Stanford University, Stanford, CA, United States. 2. Interventional Radiology, Carolinas Medical Center, Charlotte, NC, United States. 3. Interventional Radiology, Piedmont Healthcare, Atlanta, GA, United States. 4. Interventional Radiology, Sky Ridge Medical Center, Lone tree, CO, United States. 5. Interventional Radiology, University of New South Wales, Sydney, NSW, Australia. 6. Interventional Radiology, St. Luke’s Hospital of Kansas City, Kansas City, MO, United States.

Author(s): Dr. John Louie, MD, Stanford University, Stanford, CA

Purpose:  Non-target embolization, especially of radioembolic or drug-eluting microspheres, can result in devastating complications. The recently FDA-approved Surefire Infusion System (SIS) was designed to eliminate reflux that can result in non-target embolization. We describe the initial experience of the SIS device in human subjects.

Materials:  29 embolization procedures were performed on 29 patients at 7 institutions. Patients were treated for hepatic metastatic disease (59%), hepatocellular carcinoma (21%), renal cell carcinoma (3%), and angiomyolipoma (3%). SIS was used in 17 radioembolizations (16 resin and 1 glass microspheres), 5 chemoembolizations (LC drug-eluting beads), 2 bland embolizations (using Embospheres), and 5 TcMAA infusions. The diameter of the vessels in which the device was deployed ranged from 3.7 mm to 6.0 mm (mean 4.7mm).

Results:  The device was successfully deployed in target vessels in 100% of patients, including in those with severe tortuosity. Moderate vasospasm was seen in one case (3%) but there was no flow-limiting spasm, dissections, or thromboses. Successful infusion of therapeutic agent was successfully completed in all patients (100%). There was no angiographic evidence of reflux, including in patients in whom stasis was reached. In chemoembolization patients, completion C-arm CT imaging suggested a pattern of increased microsphere tumor penetration and contrast retention. In short term follow-up, no clinical evidence of non-target embolization was observed.

Conclusions:  The Surefire Infusion System appears to be safe and effective for embolization treatments with potential for reduction of non-target embolization and its consequences.

Categories: Oncologic Interventions

J. D. Louie, E. A. Wang, S. Broadwell, B. C. Wible, A. Arepally, C. Nutting, L. Bester, D. Y. Sze. First in Man Experience with the Surefire Infusion System – A dedicated microcatheter system to eliminate reflux during embolotherapy. Presented during Society of Interventional Radiology Annual Scientific Meeting, March 2012.

Surefire Medical Inc.

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