SCOUT® Radar Localization

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Merit Oncology - Reducing the Burden of Breast Cancer on Women and Their Families

THE PREFERRED LOCALIZATION SOLUTION TO TREAT MORE PATIENTS

The SCOUT system has been clinically demonstrated to drive value and improve patient outcomes. SCOUT is proven to improve radiology workflow and significantly reduce OR delays. Using SCOUT, surgeons can precisely target the affected tissue to pinpoint its location within 1mm, which can mean more successful surgeries, optimized breast conservation strategies, and enhanced outcomes for women.

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HOW DOES SCOUT RADAR LOCALIZATION WORK?

INTRODUCING THE SCOUT CART

PRECISION & PATIENT EXPERIENCE WIRE-FREE LOCALIZATION

WIRE-FREE LOCALIZATION AT BIOPSY

WIRE-FREE LOCALIZATION TECHNOLOGIES

Features & Benefits

SCOUT saves ~$2300 per procedure, 97% of patients would recommend, and 85% of radiologists report a better workflow

Breast Tumor Under MRI

DETECT

  • After detection, physician and patient can opt to place the Reflector when the biopsy occurs
  • Long-term implant of the Reflector can be placed any time prior to surgery
  • Ultrasound, radiographic and stereotactic guidance options can all be used to place the Reflector

LOCALIZE

  • Reflector remains in place and passive until activated by the SCOUT Guide
  • Can be used to mark soft tissue, including lymph nodes
  • 4mm body size is smaller than a grain of rice
  • Antennas are made of superelastic nitinol alloy, commonly used in medical devices

SCOUT Guides Identify the Reflector

IDENTIFY

  • Real-time distance measurement with 60mm detection range
  • 360 ̊ detection with ± 1mm accuracy
  • Documented 99.2% reliability
  • Instant response guides dissection path, eliminating guesswork
  • SCOUT Access Guide allows localization through small incisions

Brent Parkinson, MD“I want to reiterate how care has improved since we started placing SCOUT Reflectors at the time of biopsy, which in most cases, is on the same day as the diagnostic mammogram. Women who’ve had previous wire localizations comment on the ease of the procedure, compared to traditional localization. They also love that they don’t have to return to the breast center for biopsy, and then again for a localization procedure.

One product, two steps eliminated. Patient satisfaction is through the roof. Patients know they are getting streamlined care at our breast care center. I so appreciate Merit for developing a product that has revolutionized care.”

Brett Parkinson, MD
Imaging Director Breast Care Services
Intermountain Healthcare, Salt Lake City UT

CONSISTENCY & PREDICTABILITY

FROM CLINICAL PERFORMANCE

Step 1: Informed Pre-Surgical Planning

Step 1 - Informed Pre-Surgical Planning

Precisely Identifies Tumor Location & Depth

  • 60mm detection range2
  • Permits cosmetically-preferred incision
  • Actual distance measurement allows real-time planning of anterior margin

Step 2: Real-Time Margin Definition During Surgery

Step 2: Real-Time Margin Definition During Surgery

Helps Optimize Surgical Goals

  • 360˚ detection with ± 1mm accuracy2
  • Instant response guides dissection path, eliminating guesswork
  • Predictable specimen with real-time margin definition

Step 3: Accurate Specimen Verification

Step 3: Accurate Specimen Verification

Optimizes Breast Conservation Strategy

  • Confirms planned surgical margins relative to reflector location
  • Accurate depth measurement when patients are in supine position

ACCURACY

IN DEPTH MEASUREMENT MATTERS

The SCOUT system’s true distance measurement overcomes challenges with mammography images when estimating tumor depth & location during supine surgical procedures, and allows surgeons to quickly identify location and depth of reflector.

Mammographic Upright Views Prior to Surgery

Measurement to Tumor in Supine Position Differs


VISIBILITY

EXCELLENT UNDER IMAGING

CLEAR VISIBILITY UNDER IMAGING

  • The SCOUT System provides maximum flexibility with visualization regardless of the imaging modality.
  • Shape provides unique radiographic and ultrasound images
  • The Reflector is a clinically insignificant MRI artifact

SCOUT Reflector - Clear Visibility Regardless of Modality

INSIGNIFICANT MRI ARTIFACT

SCOUT Radar technology promotes a streamlined Targeted Axillary Dissection; allowing surgeons to more easily identify previously biopsied nodes, even after neoadjuvant chemotherapy.7,8

Allows surgeons to more easily identify previously biopsied nodes, even after neoadjuvant chemotherapy

WIRE-FREE TECHNOLOGIES COMPARISON

A study published by Dr. Mary K. Hayes showcases the clarity of the SCOUT Reflector under MRI versus those of two other wire-free technologies on the market.6

The clarity of the SCOUT Reflector under MRI versus competitors


CLINICAL DATA

FEATURE STUDY

Use of SCOUT Reflectors to Identify the Previously Biopsied Node Significantly Improves the Probability of Surgical Removal and Subsequently Reduces the False Negative Cancer Rate

KEY RESULTS

  • Only 47.4% (9 of 19) biopsied nodes were removed with conventional SLNB
    • False negative rate = 33.3%
  • All (19/19) biopsied nodes were identified and removed with SCOUT
    • False negative rate = 0% (optimal goal)

ADDITIONAL DATA AND ADVANCED THERAPY INFORMATION

  • Foundational Knowledge
  • OR Efficiency
  • Bracketing
  • Long-Term Placement
  • Neoadjuvant Chemotherapy
  • Oncoplastic Techniques
  • Targeted Axillary Dissection
  • Time of Biopsy Placement
  • Outside Breast

REFERENCES:
1. Hayes MK, Bloomquist EV, Wright H. SAVI SCOUT Improves Breast Surgery Operating Room Start Times Compared with Wire Localization. Presentation at: American Society of Breast Surgeons 18th Annual Meeting, April 2017, Dallas, TX.
2.Merit Medical Data on File
3. Cox C et al. A Prospective Single Arm, Multi-Site Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Localization of Non-Palpable Breast Lesions during Excision. Ann Surg Oncol 2016 Oct;23(10):3168-74.
4. Wright et al: It’s about time: Wire-free SCOUT localization of positive axillary lymph nodes prior to neoadjuvant chemotherapy may offer options to de-escalate axillary surgery
5. Balija et al: Reflector Localized Lymph Node Biopsy: A Novel Aide in Axillary Staging After Neoadjuvant Chemotherapy for Node-Positive Breast Cancer
6. Hayes MK. Signal void artifacts in non-contrast T1 non-fat-saturated MR sequences. Update on Preoperative Breast Localization. Radiol Clin N Am (2017); 591-603.
7. Taback B, Jajeda P, Ha R (2018). Enhanced Axillary Evaluation Using Reflector-Guided Sentinel Lymph Node Biopsy: A Prospective Feasibility Study and Comparison With Conventional Lymphatic Mapping Techniques. Clinical Breast Cancer. https://www.ncbi.nlm.nih.gov/pubmed/29544701
8. Storm-Dickerson T, Gold R. Utility of the SCOUT reflector as an efficient tool for the identification of index lymph node following completion of neoadjuvant chemotherapy. 2019. Merit Medical Systems, Inc.

Order Information

Model Number Product Description Minimum Order Quantity
SSC-01 SCOUT® Surgical Guidance Console 1
SG-01 SCOUT Surgical Guide, Multiple-Use 1
SG-02 SCOUT Access Surgical Guide, Multiple Use 1
SSCSys-01 SCOUT Console (includes one Surgical Guide) 1
SH-01 SCOUT Surgical Guide Sheath (sterile) 20
HPSU-01 SCOUT Surgical Handpiece, Single Use 5
SSR05-01 SCOUT 5 cm Delivery Needle and Reflector 5
SSR75-01 SCOUT 7.5 cm Delivery Needle and Reflector 5
SSR10-01 SCOUT 10 cm Delivery Needle and Reflector 5
SSR75S-01 SCOUT 7.5 cm Delivery Needle and Reflector, Single-Hand 5
CHK-01 SCOUT Check® Radiology Verification Console (includes one Check Handpiece) 1
CHKHP-01 SCOUT Check Radiology Handpiece, Multiple-Use 1
SCRT-01 SCOUT Console and Accessory Cart 1
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EDUCATION & MORE

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