Intact Medical Clinches New FDA Clearance to Preserve Breast Biopsy Specimens

Intact Medical Corporation (Framingham, Mass) won FDA 510(k) clearance for its Intact excision system to be used to preserve removed breast tissue of up to 30mm in diameter. Once the area is prepared, the wand is inserted through a 6mm-8mm incision and the tip expands to surround the tissue. A 10 second burst of radiofrequency energy is delivered through the tip ablating the tissue around the sample and freeing it for easy removal.

The sample maintains its architecture and is ready for standard histologic evaluation. The device comes with four different basket sizes that envelop around the sample, while the same wand is used with all four.

Dr. Pat Whitworth, Director, Nashville Breast Center, noted, “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.”

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.”

Here are a couple videos showing how the procedure works:

Intact ultrasound procedure—live:

 

Intact ultrasound procedure—schematic:

 

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