Intact Medical (Natick, Massachusetts), maker of the minimally invasive Breast Lesion Excision System (BLES), is sponsoring a multi-center, multi-disciplinary clinical trial designed to determine if BLES can help women avoid an open surgical biopsy in certain women.

The trial is expected to enroll about 4,000 women ages 18 and over, at up to 40 centers throughout the U.S. It will investigate the effectiveness of the BLES system in identifying women who have been diagnosed with atypical ductal hyperplasia (ADH), or abnormal, but benign cells in the breast that increase their risk of cancer. About 10% of biopsies taken today require a secondary biopsy, or open surgical procedure.

"We'd like to determine with this trial whether this device has a higher likelihood to make an accurate diagnosis on the first capture of tissue . . . " Intact President and CEO Christopher Bleck told Diagnostics & Imaging Week, "and we believe this device will allow the pathologist to give more definitive diagnosis on some of the high-risk lesions that currently require surgery today."

Intact met with the FDA in May to finalize protocol and began signing up investigational sites last week. However, it has not yet begun enrolling patients.

The BLES is an image-guided biopsy procedure that entails a thin wand being inserted into the side of the breast through an incision about 6 mm to 8 mm in diameter. The device is then inserted under the skin, where the incision was made.

"It's advanced because on the tip of the device there is kind of crosshairs or prongs that are metal,and they are energized using surgery or radiofrequency energy," Bleck said. "And that creates the channel, and you push the device forward to the depths in the breast that you need it to go."

Once the wand is near the lesion that the physician wants to sample, another mechanism, something "like a lasso," will advance forward. That lasso, or wire, is energized with RF energy, and it "totally circumscribes the area of interest," closing behind the tissue and capturing it in a "kind of snare basket." The device is about two and a half centimeters long, with the basket coming in four sizes ranging from one centimeter to about two centimeters.

Once the snare basket lassos the lesion, the device is retracted, and the tissue is removed from the basket – and just like needle biopsy – it is sent to a pathologist.

Bleck said, "thousands of women each year are diagnosed with ADH and other high-risk breast lesions that are benign," but that the "increased risk of breast cancer" in those women necessitate "careful monitoring, frequent mammograms and multiple biopsies."

He told D&IW that about 20% of women who are determined to have ADH are found to have something more significant when they have tissue excised, i.e., either ductal carcinoma in situ or invasive cancer.

"That's why the standard of care is that all ADH patients go on to open surgical excision," he said.

The standard needle biopsy procedure requires that a physician take from eight to 12 samples from the lesion, whereas with BLES, "that same equivalent of tissue can be captured in one intact specimen."

To participate in the trial, women must have had an imaged abnormality found via a mammogram or sonogram, which warrants a biopsy for further diagnosis.

BLES is the first product for Intact Medical, which was founded in 1998, and it was FDA-approved in late 2001. In August 2005, the company received expanded approval for BLES, allowing its use to obtain tissue samples for histologic examination with partial or complete removal of an imaged abnormality, or partial removal of a palpable abnormality that has been classified as benign.

"It's been on the market, and we've gathered some experience and some clinical trial data, which has demonstrated a very low rate of what we call these ADH upgrades," Bleck said. "Well below 10%, which has led us to this point where we believe a prospective multi-center trial … will be able to perform better than the other methods that are out in the published literature today."

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