Intact Medical Corporation Receives Expanded 510(k) Marketing Clearance From The FDA For The Intact® System

FRAMINGHAM, Mass., Jan. 12, 2015 /PRNewswire/ -- Intact Medical Corporation, a privately held medical device company which designs, develops and markets innovative, minimally invasive systems for the excision of tissue for diagnostic and therapeutic applications in select cancer markets, today announced that it has received expanded 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the Intact^® system. Specifically, the Intact technology has been cleared for its ability to preserve breast lesion architecture in samples of up to 30mm in diameter.  As a result, the minimally-invasive Intact system will allow physicians to remove intact lesions up to 30mm in diameter, with architectural integrity preserved for diagnostic assessment -- resulting in several advantages, including the potential for fewer open surgical procedures.

The minimally-invasive Intact procedure can be performed in a physician's office, with the capture of the suspicious breast lesion itself completed in less than 20 seconds.  To date, over 75,000 Intact procedures have been successfully performed in the U.S. and Europe.

John Vacha, President and Chief Executive Officer of Intact Medical, noted, "This FDA clearance represents an important milestone for the company and is an acknowledgement of the unique capabilities of the Intact technology.  With use of Intact, physicians can offer women the option of a fast and relatively simple procedure that can remove a lesion up to 30mm in diameter, while maintaining the lesion architecture for pathological analysis, versus capturing multiple samples of that tissue for analysis, which would not preserve architectural integrity.  The impact of this new, expanded application of the Intact technology means that Intact could become a welcomed first-line alternative diagnostic procedure to open surgical excision, significantly reducing patient discomfort, recovery time, and costs."   

Commenting on today's news, Dr. Pat Whitworth, Director, Nashville Breast Center, and a leading U.S. breast surgeon, stated, "This new FDA clearance is highly significant, not just for Intact Medical, but more importantly, for women's health professionals and patients, globally.  The expanded clearance recognizes the unique features and significant advantages of the Intact technology compared to core needle biopsy and open surgical excision procedures in certain situations. Specifically, for small breast lesions up to 30mm in diameter, the ability of the Intact system to remove and preserve the entire lesion architecture for assessment by the pathologist combines the minimally-invasive benefits of core biopsy with the diagnostic assurances of traditional surgical excisional biopsy. As someone who has performed more than 1,000 procedures with the Intact, I can attest to the advantages of this option for my patients."

About Intact Medical Corporation

Based in Framingham, Massachusetts, Intact Medical Corporation is a privately held company focused on the design, development and marketing of innovative, minimally invasive systems for the excision of tissue for diagnostic and therapeutic applications in select cancer markets.  The

Company's lead technology, the Intact^®, and all of the devices discussed in the press release, have received market clearance from the U.S. Food and Drug Administration as well as CE Mark approval.  Initial products are targeted at breast biopsy and the excision of benign lesions, potentially obviating the need for open surgical excisions. 

For more details on the Company, visit www.intactmedical.com

Company Contact:
Intact Medical Corporation
John F. Vacha, President & CEO
508-655-7820

Media Contact:
Rx Communications Group
Eric Goldman, Vice President
917-322-2563
[email protected]

SOURCE Intact Medical Corporation

Related Links

http://www.intactmedical.com