Healthcare Professionals

Intact Breast Lesion Excision System

Breast Surgery Applications

Overview

SEE THE WHOLE PICTURE. WITHOUT THE O.R.

The Intact™ breast lesion excision system is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. Intact is uniquely suited to preserve lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical biopsy. Operated under ultrasound or stereotactic imaging, the Intact breast lesion excision system provides high-quality, diagnostic sampling of palpable and non-palpable breast abnormalities.

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INDICATIONS

The Intact breast lesion excision system is indicated to provide tissue samples for: diagnostic sampling of breast abnormalities, histologic examination with partial or complete removal of an imaged abnormality, and histologic examination with partial removal of a palpable abnormality.

The Intact breast lesion excision system is intended to preserve lesion architecture in samples with a diameter of 12–30 mm.

Please see Indications, Safety, and Warnings for more info.


PRODUCT DETAILS

Obtain the entire sample in one pass

Utilizing radiofrequency (RF) energy, Intact deploys a wire capture basket to circumferentially surround the targeted lesion. During the capture sequence RF energy cuts and coagulates tissue, isolating the contiguous sample for removal through a 6–8 mm incision. The system can be operated directly from the handle or by using a foot pedal based on physician preference.

Intact Process Step1

A small (6–8 mm) incision is created around the lesion.

Intact Process Step3

The wand envelops the target tissue. Capture takes approximately 10 seconds.

Intact Process Step2

The Intact wand is inserted through the incision.

Intact Process Step4

The contiguous sample is withdrawn for pathology.

CLINICAL BENEFITS

  • May reduce the need for future surgeries*
  • Demonstrated ability to remove high risk lesions in patients who meet histologic and radiologic criteria1
  • Obtain surgical quality sample in 10 second capture
  • Intact provides greater amount of tissue for pathologic examination than other biopsy devices2
  • Clinical studies have reported lower upgrade rates for patients undergoing surgical excision1,3
  • Up to a 98.3% reported success rate obtaining surgically clean margins4,*,†
  • Preserves lesion architecture for pathological assessment
  • Easy pathology review
  • Local anesthesia/minimally invasive surgery (MIS) procedure 

ULTRASOUND ANIMATION VIDEO

STEREOTACTIC ANIMATION VIDEO

SURGICAL APPLICATIONS

  • Breast biopsy
  • Qualifying breast lesions

Model Specifications

Intact generator

Intact generator

  • Color display
  • Connector for Intact handle
  • Power plug with on/off switch
  • Foot pedal connector
Intact Handle

Intact handle

  • Hand or footswitch activated
  • Compatible with Lorad™ and Fischer™ tables
Intact 12mm, 15mm, and 20mm wands

Intact 12 mm, 15 mm, and 20 mm wands

  • Radiofrequency capture basket

Accessories

  • Generator cart
  • Smoke evacuator

Manuals and Technical Guides

Find these technical manuals in the Medtronic Manual Library, in the product labeling supplied with each device, or by calling Medtronic at 800-961-9055.


*

When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Complete Excision Rates were evaluated as a surrogate measure to assess the ability to remove sufficient, undisrupted tissue to preserve tissue architecture and to permit a definitive diagnosis. Success rate dependent upon lesion size/location and wand sized used during the procedure. Success rates in the literature range from 49–100%. 


1

Whitworth P, Simpson J, et al. Definitive Diagnosis for High-Risk Breast Lesions Without Open Surgical Excision: The Intact Percutaneous Excision Trial (IPET).  Ann Surg Oncl. 2009; 18:3047-3052

2

Seror, Jean-Yves.  “Predictive factors for complete excision and underestimation of one-pass en bloc excision of non-palpable breast lesions with the Intact”.  European Journal of Radiology (2011).

3

Razek, Naglaa, et al.  Percutaneous breast lesion excision system (BLES): A new tool for complete closed excision of high risk lesions (Egyptian experience). The Egyptian Journal of Radiology and Nuclear Medicine 2013;44:383-389.  

4

Allen SD, Nerurkar A, Della Rovere GU.  The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions?  European Radiology 2011 May; 21(5):919-924.


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