Healthcare Industry News:  Bayer HealthCare 

Devices Radiology

 News Release - November 19, 2007

Confirma to Showcase the Access Breast Coil(R) at RSNA in Chicago

Interventional Components Receive FDA 510(k) Clearance

BELLEVUE, Wash.--(HSMN NewsFeed)--Confirma®, pioneer and leader in application-specific CAD for magnetic resonance imaging (MRI), announced today that the Company will showcase its Access Breast Coil® at the Radiological Society of North America (RSNA) Meeting in Chicago, November 25-30 (Booth 7950, North Hall). With the addition of the Access Breast Coil to its suite of products that includes CADstream® for breast MRI, Confirma continues its vision to provide comprehensive products to imaging centers that improve quality, efficiency and standardization in breast MRI. The Access Breast Coil is designed for high-quality diagnostic imaging, flexible interventional access and optimized patient comfort.

“The Access Breast Coil offers imaging centers and their patients advanced diagnostic and interventional capabilities with exceptional ergonomics,” said Wayne Wager, president and CEO of Confirma. “The Access Breast Coil and CADstream will further improve confidence in breast MRI by providing the tools necessary to build premium, comprehensive breast MRI programs.”

The Access Breast Coil’s 4-channel, phased-array coil architecture provides high-quality parallel imaging of the breast, chest wall and axillary tissue. Access is optimized for parallel imaging and supports both bilateral and unilateral imaging. Initially, the Access Breast Coil is compatible with Siemens Avanto and Espree 1.5T MRI scanners. The Access Breast Coil has received FDA clearance and Siemens certification.

The open design of the Access Breast Coil allows for flexibility in performing interventional procedures from both lateral and medial approaches. Interventional components consist of a reusable interventional grid and stabilization plate, and are compatible with all major vacuum-assisted biopsy systems. Confirma received FDA 510(k) clearance on the Access Breast Coil’s interventional components July 2007, and anticipates market release early in the first quarter of 2008.

The design also focuses on ergonomics, allowing for enhanced patient comfort during both diagnostic and interventional exams. Positioning accessories, including a headrest and chest and torso pads, relieve pressure on the sternum and provide customized patient positioning during diagnostic and interventional breast MRI studies and procedures.

Access Breast Coil, a Dual-Purpose Coil with Extensive Access

Diagnostic Features
  • 4-channel phased array coil design for high-quality imaging
  • Optimized for parallel imaging applications
  • Extensive coverage of breast, chest wall and axilla
  • Supports unilateral and bilateral imaging
  • Compatible with Siemens Avanto, Espree and Symphony 1.5T MRI scanners
Interventional Features
  • Open coil design allows for easy lateral and medial interventional access
  • Interventional components support a wide range of needle gauge sizes and vacuum-assisted biopsy systems
  • Integrated interventional components aid breast stabilization and needle positioning
Ergonomic Features
  • Design provides maximized patient comfort
  • Accessories include adjustable headrest and torso pads for flexible, customized patient positioning
  • Cushioned adjustable headrest with mirror
  • Large apertures to accommodate a major percentage of patient population
About Breast MRI and CADstream

The ACS panel on breast cancer screening now recommends that women with a 20-25 percent or greater lifetime risk of the disease undergo an annual MRI in addition to mammography. In addition to the new ACS guidelines, a study published in the New England Journal of Medicine suggests that women with cancer found in one breast should undergo an MRI scan of the other breast.

Due to the recent news and published clinical studies supporting breast MRI for increased breast cancer detection, it is becoming increasingly important to improve analysis of these complex, time-consuming studies. CADstream is an intuitive technology that is advancing breast MRI by enhancing quality, standardization and efficiency of studies. The system automates analysis, reporting and interventional planning of studies and promotes standardization with the incorporation of the ACR BI-RADS® Atlas.

CADstream is designed for any workflow scenario, integrating with existing equipment and providing access to studies anywhere on the network. Automated features include image registration, multiplanar reformatting, subtractions, Angiogenesis Maps, curves, maximum intensity projections (MIPs), volume summaries, Portfolio for reporting, SureLoc® for interventional guidance and multimodality capability. CADstream was first introduced at the Radiological Society of North America (RSNA) meeting in 2002 and is currently in use by thousands of physician users and hundreds of breast MRI programs.

The July 2007 issue of Radiology published research from the University of Washington and Seattle Cancer Care Alliance indicating that CAD for breast MRI may improve standardization, and the analysis of benign and malignant lesions. CADstream was the CAD for breast MRI system used in this study.

About Confirma, Inc.

Confirma develops and markets application-specific CAD systems and accessories for magnetic resonance imaging studies (MRI). CADstream is the standard in CAD for MRI, with more than 800 installations and 2,500 users worldwide. Confirma’s approach to CAD is unique: CADstream is developed with specific tools for each application in order to streamline workflow and standardize study analysis. CADstream automates the analysis and interventional guidance of MRI studies, providing higher quality imaging studies, lower costs for radiology practices and improved communication tools for physicians and patients. In its initial application, CADstream was developed to assist in the analysis, interventional guidance and reporting of breast MRI studies. CADstream can be integrated into any workflow scenario, and is compatible with all MRI scanners and PACS.

Confirma supports professional development in MRI and CAD technology through its extensive medical education program, including a newly launched continuing medical education (CME) program for breast MRI through the International Center for Postgraduate Medical Education (ICPME).

Confirma has established partnerships with companies including GE Healthcare, Philips Medical Systems, Bayer HealthCare, Medipattern, Vital Images and Carestream Health. Confirma has partnered with hundreds of imaging centers and corporate partners worldwide since 2003, helping develop more standardized, high performance breast MRI programs that deliver premium patient care. Confirma Europe GmbH opened operations in Berlin to further develop the European market. Frost & Sullivan recently recognized Confirma with the 2006 Industry Innovation and Advancement Award for the U.S. CAD market. For more information, visit www.confirma.com or call 877-811-2356.


Source: Confirma, Inc

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