Intact Medical Corporation has received expanded U.S. FDA 510(k) marketing clearance for the Intact® system which sees it usable for remove intact breast lesions up to 30mm in diameter.
Intact Medical is 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. Its products are targeted at breast biopsy and the excision of benign lesions, potentially obviating the need for open surgical excisions.
The minimally-invasive system allows physicians to perform excision of lesions while preserving their architectural integrity for diagnostic assessment, so delivering the potential advantages over needle biopsy and open excision.
The newly expanded FDA indications means that the technology has now been cleared for acquiring breast lesion samples of up to 30mm in diameter.
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.”
Source: PR Newswire