Healthcare Industry News: image-guided
News Release - November 16, 2006
Intact Medical Corporation Introduces Intact(R) AdvanceNew Bladed Tip Design Both Simplifies Operation and Further Improves Specimen Quality
NATICK, Mass., Nov. 16 (HSMN NewsFeed) -- Intact Medical Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis of breast cancer, today announced the launch of the Intact® Advance, a bladed-tip design now available as a successor to the company's radio frequency (RF) precursor tip. The Intact Advance wand -- available in 12mm, 15mm, and 20mm diameter sizes -- features a precision cutting blade for positioning the wand within the breast for optimal access to the lesion of interest. The Intact Advance has FDA 510(k) clearance for the complete or partial removal of an imaged abnormality.
The bladed tip Intact Advance wand makes the Intact® Breast Lesion Excision System (BLES) more intuitive to users familiar with vacuum-assisted core needle biopsy devices. Since there is no RF energy emitted during access to the lesion, the potential for localized, proximal RF artifact is eliminated. Operation is simplified substantially by a reduction in the number of steps for specimen capture and the elimination of skin spreaders for wand insertion. Physicians will make a small (6-8mm) incision to introduce the device under the skin and simply advance forward to the breast lesion. RF energy will continue to be used during the capture stage, regardless of the size of wand used.
Commenting on today's announcement, Christopher Bleck, President and Chief Executive Officer of Intact Medical Corporation said, "The Intact Advance makes the operation of the Intact BLES much easier, similar to conventional vacuum-assisted core needle biopsy. This enables new users to immediately benefit from retrieving a fully intact specimen, with less of a learning curve in adapting to the use of RF energy. Initial reports from our clinical trial sites indicate that there is virtually zero thermal artifact on pathology slides made from specimens retrieved from the Intact Advance wand, making our percutaneous specimens of a similar quality to a surgical biopsy."
The Intact Breast Lesion Excision System is a vacuum-assisted, image-guided procedure in which a slender wand is inserted through a small incision in the breast to remove an intact sample of suspicious tissue for histopathological analysis. The procedure is performed under local anesthesia in an outpatient setting, with the actual capture of the breast lesion completed in less than 10 seconds. After the lesion is withdrawn, the incision is effectively closed with a bandage, requiring no stitches.
About Intact Medical Corporation
Founded in 1998, and based in Natick, Massachusetts, Intact Medical Corporation is a privately held company focused on the design, development and marketing of innovative, minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications in select cancer markets. The Company's lead product, the Intact Breast Lesion Excision System, received market clearance from the Food and Drug Administration in June 2001. Initial products are targeted at breast biopsy and the excision of benign lesions, potentially obviating the need for open surgical excisions. In August 2005, the company received expanded approval for the System, allowing its use to obtain tissue samples for histologic examination with partial or complete removal of an imaged abnormality, or partial removal of a palpable abnormality that has been classified as benign.
For more details on the Company, visit www.intactmedical.com
Source: Intact Medical
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