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Cryoablation of Early Invasive Ductal Breast Cancer With MRI Confirmation Shows Promising Clinical Benefits, According to Study Presented at RSNA

CHICAGO, Dec. 5 /PRNewswire/ -- Early clinical experience with the FDA cleared Visica 2(TM) Treatment System from Sanarus Medical confirms the effectiveness of ultrasound guided cryoablation to completely eradicate small, unifocal Invasive Ductal Breast Cancer (IDC). Initial data from this multi-center study was presented at the 94th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), November 29 - December 5, 2008.

The study, "New Findings on Contrast-enhanced Magnetic Resonance Imaging, the "Black Hole" and "Cryohalo" are Markers for the Efficacy of Ultrasound-guided Cryoablation of Small Unifocal Invasive Ductal Breast Cancer," presented by Gary Levine, MD, Director of Breast Imaging at Hoag Breast Care Center in Newport Beach, Calif., was designed to evaluate the ability of breast contrast enhanced MRI to assess the effectiveness of ultrasound guided cryoablation for the local treatment of small, unifocal IDC.

"With a large body of evidence demonstrating the ability of cryoablation to destroy cancerous and noncancerous tumors of the liver, prostate, kidney and breast, the gating factor for the treatment of breast cancer tumors was the ability to visualize the extent of the tumor in advance and confirm target destruction post-procedure," said Dr. Levine. "We are very encouraged that our preliminary results demonstrate that in selected early IDC breast cancers, cryoablation with MRI confirmation may offer the same therapeutic benefit as lumpectomy with less morbidity, improved cosmesis and less cost."

Patients with newly diagnosed IDC underwent an "early" pre-ablation CEMRI to establish its MR enhancement pattern. Ultrasound-guided cryoablation was then performed using a Visica Treatment System to ablate the malignant tumor and a margin of surrounding tissue. A "delayed" CEMRI was performed approximately four weeks post-ablation followed by a standard surgical lumpectomy. The early and delayed CEMRI findings were correlated with the surgical histopathology. In all 15 cases, the post-ablation MRI's showed no suspicious contrast enhancement remaining at the targeted tumor site and histopathology confirmed complete tumor kill within the intended ablation zone. In three cases histopathology confirmed residual DCIS and/or small satellite lesions outside the cryoablation zone.

At delayed CEMRI, previously unreported characteristic and reproducible findings of signal void on post-contrast subtraction images ("black hole") correlates with an area of coagulation necrosis at the cryoablation site and a surrounding uniform thin rim enhancement ("cryohalo") corresponds to a zone of inflammation at the cryoablation margin.

"Lack of residual suspicious enhancement on post-cryoablation CEMRI appears to correlate with complete tumor kill within the targeted ablation zone. We believe the novel MR findings termed "black hole" and "cryohalo" serve as markers for successful ablation, giving us a noninvasive and reproducible method to verify clinical results," added Dr. Levine.

The study conducted by Dr. Levine and Steven Poplack, MD, Co-Director of Breast Imaging at Dartmouth Hitchcock Medical Center is similar to the National Cancer Institute (NCI) funded clinical trial recently initiated by the American College of Surgeons Oncology Group (ACOSOG). Titled, "A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma," the ACOSOG study will also evaluate cryoablation as well as the ability of MRI to evaluate post-cryoablation efficacy. The Visica 2 System was selected as the exclusive cryoablation technology to be utilized in the ACOSOG study.

Cryoablation is a minimally invasive non-surgical procedure that uses extreme cold to destroy tumors. The Sanarus Visica System has predominately been used in the cryoablation of non-cancerous tumors called fibroadenomas since its initial FDA market clearance in March of 2002. This office-based procedure, which usually takes less than 20 minutes, involves placing a small needle into the center of the fibroadenoma using ultrasound guidance and subsequently freezing and killing the tumor. The safety and efficacy of cryoablation have been well established in over 2,000 fibroadenomas that have been treated with the System to date.

This study was presented at RSNA as part of the Breast Imaging (Interventional) Session, #SST01-05, Friday, December 5 at 11:10am in Room E253CD:

New Findings on Contrast-enhanced Magnetic Resonance Imaging (CEMRI), the "Black Hole" and "Cryohalo" are Markers for the Efficacy of Ultrasound (US)-guided Cryoablation of Small (less than or equal to 15mm) Unifocal Invasive Ductal Breast Cancer

GLevine, FSHeinemann, Hoag Breast Care Center, Newport Beach, CA; SPoplack, RBarth, WWells, Dartmouth Hitchcock Medical Center, Lebanon, NH

About Sanarus Medical

Sanarus Medical is based in Pleasanton, Calif., and is focused on providing patients and physicians with minimally invasive, office-based breast care management solutions from diagnosis to treatment. Using cryoablation technology, Sanarus has developed proprietary technologies to provide breast surgeons and radiologists with a comprehensive and minimally invasive way to diagnose and treat breast patients. The Sanarus technologies change the way that patients are managed, from an operating room-based, surgically intensive care pathway to a more comfortable, cost effective, office-based care pathway. The company's Website is

SOURCE Sanarus Medical, Inc.
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