2. 2 | VARIAN ONCOLOGY SYSTEMS
VARIAN
ONCOLOGY
SYSTEMS
CALYPSO® SYSTEM AND
PROSTATE BEACON® IMPLANT
OVERVIEW
November12, 2014
2
Brian Young
3. 6 | VARIAN ONCOLOGY SYSTEMS
• Locates and continuously tracks
target location
• The 4D Electromagnetic Array
excites the transponders and then
receives position information from
their response signals
GPS for the Body® Technology
TrackTarget
Locations
4. Platform Overview
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4D Console
4D Tracking Station
4D ElectromagneticArray
Optical System
with 3 Infrared Cameras
Implanted Beacon®
Electromagnetic Transponders
5. GPS for the Body® Technology
• Wireless Miniature Beacon®
Transponders
• Accurate, quantitative guidance for
prostate localization
• Continuous, real-time tracking
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0
6. GPS for the Body® Technology
• Unique frequencies identify location
• Implanted in a 15-minute outpatient
procedure*
* Data on File
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7. GPS for the Body® Technology
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8. GPS for the Body® Technology
Step 1
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9. GPS for the Body® Technology
Step 1 Step 2
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11. • 160+ Calypso® Systems sold in US
• 180+ Calypso® Systems sold
worldwide
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Calypso® Update
Growing
Customer
Base
13. • Patients were evaluated before and
after treatment
• Patients treated without Calypso®
reported significantly more side effects
compared to those treated with
Calypso® real-time tracking in three of
the four categories surveyed
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AIM Study, Journal of Urology 2010
Reduced
Toxicities
14. Increase in average side effects at end of
radiation treatment
•* AIM Study, Journal of Urology 2010
Bowel/Rectal
Problems
Urinary
Irritation/Obstruct
ion
Urinary
Incontinenece
Sexual
Dysfuntion
Without Calypso®With Calypso®
2.1%
16.9%
4.7%
19.1%
7.2%
8.5%
0%
18.8%
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16. Prostate and Prostatic Bed Implant Training
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• Contraindications, warnings, precautions
• Patient selection considerations
• Pre-implant patient preparation
• Pre-implant equipment preparation
• Implantation process
• Possible adverse reactions
• Frequently asked questions
17. Indications for Use
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LBL0212-000 Rev A 2012-3-30
• The Calypso® System is intended for use as an adjunct in treatment planning
and radiation therapy, to align and/or monitor the patient’s position relative to
the isocenter of a radiation therapy system. The Calypso® System provides
accurate, precise and continuous localization of a treatment isocenter by
using two or more Beacon® transponders.
• The Dynamic Edge Gating® component may signal a radiation therapy
system to impose a beam-hold when the treatment target position has moved
outside the defined tracking limits and to signal the radiation therapy system
to remove the beam-hold upon the target’s return to a position inside the
defined tracking limits. The Dynamic Edge Gating® feature has been shown
to be compatible with Varian and Siemens radiation therapy systems and
external gating interfaces.
18. Indications for Use
28 | VARIAN ONCOLOGY SYSTEMS
LBL0212-000 Rev A 2012-3-30
• Implanted Beacon transponders are indicated for use to radiographically and
electromagnetically mark soft tissue for future therapeutic procedures.
• Permanent Beacon transponders are indicated for implantation in the
prostate and the peri-prostatic tissue, to align and monitor the treatment
isocenter in real time during radiation therapy.
• Surface Beacon transponders are indicated for temporary external placement
on the skin, to monitor respiratory motion and other patient motion in real
time during radiation therapy.
19. Implant Contraindications
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LBL0212-000 Rev A 2012-3-30
• Hip prosthesis
• Anti-coagulant or anti-platelet drug therapy
• Low dose aspirin is not contraindicated
20. Warnings, per FDA Guidelines
30 | VARIAN ONCOLOGY SYSTEMS
LBL0212-000 Rev A 2012-3-30
• Effect of the electromagnetic fields generated by the Calypso® 4D
Localization System in the presence of other active medical device
implants, such as pacemakers and defibrillators or other medical
devices, is unknown and may impact operation
• Beacon® electromagnetic transponders and introducers are gamma
sterilized and pyrogen free
• Use standard operating proceduresto maintain the sterility of the devices
• Do not use packages which have been previously opened ordamaged
• Beacon Transponders and introducers are designed for single use
only
• Do not re-sterilize or reuse
• Each Beacon transponder is tuned to a specific frequency and is to be
implanted in a designated region of the prostate
• Labeling indicates the intendedregion
21. Warnings, per FDA Guidelines
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LBL0212-000 Rev A 2012-3-30
• Use transrectal ultrasound imaging for guidance in
implantation
• During procedure preparation, if a Beacon®
electromagnetic transponder drops onto sterile field and
sterility is uncompromised:
• Do not use metal tweezers to retrieve the Beacon transponder
• Retrieve the Beacon transponder with a gloved hand
• Place it directly into the hub end of the introducer
• Do not use non-sterile or damaged introducers or
Beacon transponders
22. Precautions, per FDA Guidelines
• Non-clinical testing has demonstrated that Beacon
transponders are MR conditional. Apatient implanted with
Beacon transponders can be safely scanned under the
following conditions:
• Static magnetic field of 1.5T or 3T;
• Static magnetic field gradient of 2.5 T/m; maximum
whole-body-averaged
• Specific absorption rate of 2.0 W/kg for 20 minutes, in
the normal operating mode of MR scanning.
• A local MR image artifact may extend up to approximately2
cm from the transponder.
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LBL0212-000 Rev A 2012-3-30
23. Precautions, per FDA Guidelines
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LBL0212-000 Rev A 2012-3-30
• No specific evaluations have been made with transponders in the
presence of the following procedures
• LDR or HDR brachytherapy
• Electrosurgical procedures
• Harmonic scalpel, transurethral needle ablation, radiofrequency
ablation, cryoablation or lithotripsy
• The Calypso Beacon® transponder implantation training program
must be completed prior to implanting transponders in the prostate
24. Patient Selection Criteria
1 Place patient supine lying on a flat, hard
surface in the treatment position.
2 Measure from the table top to the maximum
anterior skin surface distance (A).
3 Record this distance in centimeters.
4 Estimate center position of patient’s prostate
by palpating the greater trochanter notch on
the lateral side of the femur.
5 Measure the distance from the table top to the
approximate prostate center (B).
6 Record this distance in centimeters.
7 Subtract A – B and use result to determineif
the patient is a candidate.
An optional CT image confirms implant
feasibility
Formula
A: Maximum anterior/posterior distance
B: Anticipated prostate isocenter
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LBL0212-000 Rev A 2012-3-30
A – B < 19 cm = Localize and Track
A – B = 17 cm to 25 cm = Localize Only
A – B > 25 cm = Ineligible for implant
25. Beacon® Transponder ImplantationInstructions
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Prior to Implantation Procedure
• Prepare patient according to institutional guidelines
• Administer antibiotic prophylaxis
• Bowel preparation for transrectal ultrasound
Day of Implantation
• Pre-load Beacon transponders into introducers and place on a sterile drape
• Prepare the patient for transrectal ultrasound examination
• Attach a sterile 14 gauge needle guide to the transrectal ultrasound
transducer
26. The Implant Procedure
Three Beacon® transponders are implanted in the prostate
Implant uses the same technique and equipment as a prostate biopsy
procedure
Implantation of Beacon transponders uses the same
technique as the implantation of other radiopaque markers
Standard UltrasoundProbe
Introducer Needle
Commercially available transrectal ultrasound probe guides
implantation of Beacon transponders
36 | VARIAN ONCOLOGY SYSTEMS
27. Beacon® Electromagnetic Transponders
• Beacon transponders consist of
• A miniature passive electrical circuit hermetically sealedin
biocompatible glass
• The Beacon transponders are visible on kV xray, CT,
• ultrasound
• Each Beacon transponder is packaged in a transfer
capsule
• Transfer capsules facilitate loading the Beacon
transponder into the introducer
• Capsules are color-coded indicating implant location
A = Apex (white)
L = Left mid-gland or base (blue)
R = Right mid-gland or base (green)
Implant Components
Transfer Capsule
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Beacon Transponder
length = 8.5mm
diameter = 1.8mm
28. Implant Components
• Introducers
• Introducer hubs and stylets are color-coded to indicate the frequency
of the loaded Beacon transponder
• Each Beacon® electromagnetic transponders has a unique frequency
Right Base
Left Base
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Apex
29. Implant Recommendations
• To ensure optimal localization accuracy:
• Implant Beacon® electromagnetic transponders
equidistant to prostate midpoint
• Avoid implanting the Beacon transponders adjacent to
urethra
• Attempt to place >1 centimeter apart from each other
• If 1 cm separation is not feasible, position Beacon
transponders as far apart from each other as possible
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30. Implant Recommendations
• In the event order of implant is altered
• The Calypso System software may be modified to correct the
incorrect positions
• If a correction is required, inform radiation oncology departmentprior
to treatment planning
• For highest localization accuracy
• Implant the three Beacon® electromagnetic transponders in a
triangular pattern
• Spread Beacon transponders apart from each other, ideally>1cm
• Avoid placement near the urethra
• In the event a Beacon transponder is voided post-implant,the
Calypso System can recognize two Beacon transponders
• Accuracy with < three Beacon transponders is reduced
• Implant Beacon transponders within the prostate
capsule
• Avoid seminal vesicles or any areas outside theprostate
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31. Most Common Implant “Issues”
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• Beacons placed too close to one another.
• Beacons placed in/near rectal wall.
• Beacons are too coplanar.
• Beacons placed outside of prostate.
32. After Implantation Procedure
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• Review post-operative care orders
• Review potential complications
• Refer patient to radiation therapy for
treatment planning
• A waiting period of 4 - 14 days recovery is recommended prior to
treatment planning CT to stabilize the Beacon® electromagnetic
transponder and reduce prostate swelling
33. Adverse Reactions
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• Potential adverse events may include
• Bleeding (e.g., hematuria, hematospermia, hematochezia)
• Pain (e.g., procedural, perineal, bowel movements, unspecified)
• Infection (e.g., urinary tract infection)
• Fever
• Less common adverse events may include
• Urinary retention
• Urinary obstructive symptoms (e.g., urinary frequency, weak stream,etc.)
• Dysuria
• Migration of Beacon® electromagnetic transponder from implant site or
out of the body
34. Overview: Prostatic Bed
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The overall implant training is similar to implanting transponders in
the intact prostate procedure.
Requirements common to both procedures:
• Patient size requirements
• Patient needs to meet implant criteria and contraindications
• Patient preparation prior to day of implantation
• Handling the product
• Preparing the product with the needle guide
• Minimum distance between transponders of 1cm apart in triangular pattern
• Color coded introducer stylets & hubs for specific region of prostatic bed
• After implantation procedure
Additional prostatic bed implant requirements:
• Implant site selection
• Post Operative Transrectal
35. 64 | VA RIAN ONCOLOGY SYSTEMS
Prostatic Bed: Post-Prostatectomy
Transrectal Implantation
• Implant at least 2-3 weeks post-prostatectomy in order to avoid
movement of the transponders
• Allows for reduction of edema and initiation of fibrosis in the
prostatic bed
• The recommended distance between the transponders is 2 cm
• Recommended minimum distance: 1cm
• Recommended maximum distance: 6cm
Color Implantation Position in Post Operative Transrectal
White
(Apex)
On right side of anastomosis site
Blue
(Left)
Between bladder and rectal wall, left side (behind trigone)
Green
(Right)
Between the bladder and rectal wall, right side (behind trigone)
36. Implantation Sites –
Postoperative Transrectal
•Optimal implantation locations
•Recommended distance between transponders is 2.0 cm
NOTE:
66 | VARIAN ONCOLOGY SYSTEMS
Recommended min distance is 1.0cm
Recommended max distance is 6.0cm
SAG
Transverse
AP
37. Summary
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• Patient size is acceptable for localization and/or tracking
• Patient needs to meet implant criteria and contraindications
• Pre and post patient instructions per clinical guide lines
• Handling the product
• Sterile product
• Handling if dropped
• Keeping it out of urethra or other conduits
• Preparing the product with the needle guide
• Spacing of the Beacon® electromagnetic transponders is critical for
accuracy of localization and tracking (>1cm apart in triangular pattern)
• Identify target implant sites for optimal accuracy
• Color coded for specific region of prostate
• Implant Technique and manage tenting
• Patient Implant Card
38. Calypso® Online Implant Training Course
81 | VARIAN ONCOLOGY SYSTEMS
www.calypsoeinstitute.com
30-minute course reviews contraindications, patient
selection criteria and recommended technique.
