Medical device company Intact Medical (IMC) has obtained expanded 510(k) marketing approval from the US Food and Drug Administration (FDA) for its Intact system.
The approval has been secured for its ability to preserve breast lesion architecture in samples of up to 30mm in diameter.
The minimally-invasive system will help physicians to remove intact lesions up to 30mm in diameter and offers several advantages, including the potential for fewer open surgical procedures.
Intact Medical president and CEO John Vacha said: "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."
According to the company, the 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.
The company develops and markets minimally invasive systems for the excision of tissue for diagnostic and therapeutic applications in select cancer markets.