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NATICK, Mass., Sept. 16 /PRNewswire/ -- Intact Medical Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis and removal of breast lesions, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Intact (R) Excise XL - a larger version of the Company's already FDA approved wands, used with the Intact (R) Breast Lesion Excision System (BLES). The Company expects to begin marketing the product to physicians in the fourth quarter of this year.
As with the Intact (R) BLES, the Intact (R) Excise XL procedure involves the insertion of a slender wand through a small incision in the breast to remove an intact sample of suspicious tissue for histopathologic analysis. The procedure can be performed in an office-based or outpatient setting, with the actual capture of the breast lesion completed in less than 20 seconds. To date, over 30,000 Intact (R) BLES procedures have been performed in the U.S. and Europe.
Christopher Bleck, President and Chief Executive Officer of Intact Medical, noted, "With the recent FDA clearance, the Intact (R) Excise XL represents an important line extension, providing greater choice for physicians and patients. Since it allows for extraction of larger, intact breast tissue, it has the potential to provide both a more accurate histopathologic assessment and the complete excision of even larger suspicious lesions. The Excise XL, with its larger capture basket, is a first-line alternative to surgical excision for any suspicious lesion 1.5cm (or smaller) in diameter. Under stereotactic or ultrasound image guidance, the Excise XL permits surgeons to completely excise small lesions along with the potential to evaluate tissue margins in a single, minimally-invasive procedure."
Mr. Bleck continued, "There are over 400,000 surgical breast procedures
(excisional biopsies) for initial diagnostic purposes and more than 700,000
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