FDA grants 510(k) marketing clearance for IMC’s Intact system

The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for Intact Medical’s (IMC) Intact system.

IMC designs, develops and markets new minimally invasive systems for the excision of tissue for diagnostic and therapeutic applications in select cancer markets.

FDA approval was secured for Intact technology’s ability to preserve breast lesion architecture in samples of up to 30mm in diameter.

Nashville Breast Center director Dr Pat Whitworth said: "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 recognises 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."

The minimally invasive system will help physicians to remove intact lesions of up to 30mm in diameter and offers several advantages, including the potential for fewer open surgical procedures.

The company said the Intact procedure can be performed in a physician’s office, with the capture of suspicious breast lesion itself completed in less than 20 seconds.

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