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 benign lesion removals performed in the U.S. each year. Within this population, we expect the introduction of the Excise XL to result in increased usage of the System, as it provides physicians with a greater measure of flexibility in removing and diagnosing suspicious lesions of the breast. The new, larger capture basket will also allow physicians to remove the entire lump with the non-invasive Intact(R) System, versus an open surgical procedure, which is commonly used with larger lesions.”
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
CONTACT: Christopher Bleck, President & CEO of Intact Medical Corporation,
+1-508-655-7820; Paula Schwartz (investors), +1-917-322-2216, or Eric
Goldman (media), +1-917-322-2563, both of Rx Communications Group, for
Intact Medical Corporation
Web site: http://www.intactmedical.com/
