Scroll down for more information.

As a medical professional, you’re always searching for ways to better serve patients who are diagnosed with suspicious breast lesions. With Intact, you can help lessen physical and emotional stress, prevent unnecessary surgery, and speed recovery.

A truly unique biopsy system

Unlike other procedures, Intact surrounds and removes the imaged abnormality using radiofrequency (RF) technology in a single 10-second capture. The result: a complete surgical-quality specimen for histological evaluation and margin assessment that provides a definitive diagnosis, the first time.
Intact device

The Intact process at a glance

Image

The target lesion area is prepared for the Intact procedure.

Image

With a small (6mm-8mm) incision, an Intact wand can easily access the target lesion under image guidance.

Image

Intact envelops the target tissue—and capture takes less than 10 seconds.

Image

The single intact sample is withdrawn.

Sample capture sizes

Intact offers four different capture basket sizes. Each deploys from the same wand.
Image

Intact Wand Diameter: 10mm
Basket Dimensions: 10mm x 14mm
Specimen Weight: .8g

Image

Intact Wand Diameter: 12mm
Basket Dimensions: 12mm x 17mm
Specimen Weight: 1.1g

Image

Intact Wand Diameter: 15mm
Basket Dimensions: 15mm x 21mm
Specimen Weight: 2.1g

Image

Intact Wand Diameter: 20mm
Basket Dimensions: 20mm x 25mm
Specimen Weight: 3.0g

Intact procedure videos

Intact ultrasound procedure—live
Intact ultrasound procedure—schematic
Intact stereotactic procedure—live
Intact stereotactic procedure—schematic

Important information for technologists

Intact is easy to set up and disassemble—simply load the wand into the handle, attach the disposable tubing, and you’re ready to begin the procedure.
Image

Apply anesthetic to form a sleeve…

Image

…in four quadrants.

Image

Apply behind the lesion…

.
Image

…and along the needle track.

Diagnostic procedures at a glance

Intact breast lesion specimen system
Image
Treatment
Image
Radiology
Image
Histology
Benefits
  • Delivers a sample with intact architecture from the area of interest
  • Easy pathology review
  • Percutaneously obtain surgical-quality sample using image guidance
  • In-office under local anesthesia
Data (Upgrades at excision/re-excision)
  • 0% upgrades at surgical excision 1, 2, 3
  • Margins 2mm+ demonstrate 100% rate of no residual cancer 4
  • Cancers that were totally excised during stereotactic biopsy ranged between 1mm-10mm in 87.5% of cases (Avg. 6.9mm) 4
  • Complete removal occurred in 49% of patients for whom Intact had been used for biopsy and in 14% of patients for whom the Mammotome was used. 10
Surgery
Image
Treatment
Image
Radiology
Image
Histology
Benefits
  • Intact architecture
  • Clear margins around area of interest
  • Easy pathology review
Data (Upgrades at excision/re-excision)
  • For patients with negative margins, re-excision rates varied widely among surgeons (Range, 0%-70%; P = .003) 5
VACNB
Image
Treatment
Image
Radiology
Image
Histology
Benefits
  • Small incision
  • In-office under local anesthesia
Data (Upgrades at excision/re-excision)
  • Twelve cases were upgraded to DCIS and one case to invasive carcinoma. Histological examination yielded ADH in 8.4% of cases (33 of 395) in which a 9-gauge device was used. 6
  • (N-177) 25 cases of ADH had been underestimated, which was subsequently confirmed by surgical biopsy. 7
  • Underestimation of ADH and DCIS was 18.2% (2 of 11) and 19.2% (9 of 47), respectively. 8
Principle of tru-cut biopsy
Image
Treatment
Image
Radiology
Benefits
  • Small incision
  • In-office under local anesthesia
Data (Upgrades at excision/re-excision)
  • The highest upgrade rates were seen when 14-gauge tru-cut needles (44%) were used and when ≤5 cores (48%) were harvested. 9

Testimonials

  • “With Intact, we’re able to capture a larger specimen. This is a significant advantage, because so much of what is now re-excised represents minimal ADH. With a larger specimen, we can reduce the number of patients being excised for columnar alternation. Plus, there’s a much greater chance that we can avoid an upgrade.”

    Michael D. Lagious, M.D.

    The Breast Cancer Consultation Service, Tiburon, California

  • “Having only a core through a lesion does not allow us to know what is on either side of the lesion in that linear core biopsy. We are missing a very important criterion: the architecture of the lesion. Intact allows the pathologist to formulate a better tissue diagnosis.”

    Ruth H. Oneson, M.D.

    Pathologist, Heartland Pathology Associates, Edmund, Oklahoma

  • “I’ve been using Intact for more than five years and, during that time, I’ve been able to use the system on approximately 98% of my patients. Overwhelmingly, the response to Intact has been positive. For starters, it’s minimally invasive. Removing a 20mm specimen is done through one incision, and uses the same amount of anesthesia as a vacuum-assisted device. Plus, the procedure only takes about 10 seconds to perform. Intact can prevent further surgical excisions when noncancerous pathology is identified and can excise cancers completely—helping significantly reduce re-excision rates.”

    Steven Schonholz, M.D., FACS

    Medical Director, Comprehensive Breast Program, Noble Hospital, Westfield, Massachusetts

  • “Simply put, this is new technology that in many cases allows the surgeon to accomplish the established standard goals of modern breast lesion surgery with less cost, less morbidity, and less removal of healthy tissue. The targeted tissue is removed with margins intact for standard histologic evaluation.”

    Patrick W. Whitworth, Jr., M.D.

    Tennessee Women's Care, PC in Nashville