Intact Medical Corporation, a minimally invasive device company, announced yesterday that its Intact system received expanded FDA clearance. It has been approved for removing breast lesions up to 30 millimeters in diameter, while preserving the lesions' architectural integrity for diagnostic assessment.
"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," John Vacha, president and CEO of Intact Medical, said in a statement.
A procedure using Intact can be performed in a physician's office and takes less than 20 seconds. More than 75,000 procedures have been successfully performed in the U.S. and Europe, according to the company.
During the procedure, a 6 to 8 millimeter incision is made and the Intact wand targets the lesion with the help of image guidance. The wand then encompasses the lesion in less than 10 seconds, and then the physician extracts it.
Dr. Pat Whitworth, director of the Nashville Breast Center, is a proponent of Intact after performing over 1,000 procedures with it. "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," she said in a statement.
She added that it "combines the minimally invasive benefits of core biopsy with the diagnostic assurances of traditional surgical excisional biopsy."
