PrecisionTM Plus
8
Precision TM Plus Rechargeable Spinal Cord Stimulation System
Transcript of PrecisionTM Plus
PrecisionTM Plus Rechargeable Spinal Cord Stimulation System
The Power of Multiple Independent Current Control Only the Precision Plus pulse generator has the ability to control the level of power delivered to simultaneously active contacts.*
The 16 sources that Precision Plus features, give physicians an unmatched power and flexibility in targeting complex pain syndromes, difficult to treat with conventional systems.
Impedance Happens. Precision Adjusts. Impedance varies from contact to contact at time of implant. As patient scarring occurs, impedances change over time.d Precision Plus is the ONLY SCS System that can automatically adjust to impedance changes to maintain therapy over time.d
Joystick Control There is no easier way to navigate the electrical field and resulting stimulation to the painful areas than by using a joystick. Moreover, the patient can use the joystick during programming to match paresthesia with painful areas: Patients know their pain best.
Tightly Spaced Contacts The percutaneous and surgical leads with tightly spaced contact arrays provide an excellent spatial resolution and allow for shift by 1% of electrical field which enables fine tuning the stimulation.
Bionic Navigator™
A user-friendly clinician programmer software that makes adjusting parameters of stimulation easy. It enables physicians to assess stimulation combinations at a suprathreshold level allowing for patient’s continuous feedback. Thousands of combinations e can be tested in only minutes.
SmoothWave™ Technology
Sources: Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio.
Ohms
2- w
ee ks
3- m
o n
th s
6- m
o n
th s
Im p
la n
Precisely Target Pain with the Precision™ Plus SCS System
* Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
EGL™ Scan Shows Relative Lead Position in Seconds
Only the Precision Plus SCS System offers EGL (Electronically Generated Lead) Scan™ Technology, an exciting proprietary technology that shows the relative position of two implanted leads. In conjunction with the Bionic Navigator™ software, physicians can use EGL™ Scan information to assess relative rostrocaudal lead migration.
The Precision Plus SCS System generates and measures electrical stimulation field potentials. These measurements are used to develop a spatial map that indicates the relative position of the contacts to one another. EGL Scan Technology is the only system to date that uses electrical stimulation field potentials to allow clinicians to visualize relative lead position without fluoro or x-ray.
Technology
Show relative lead position without fluoro in seconds.
In about 20 seconds, the results are displayed graphically on your Clinician Programmer.
Efficacy
Efficient and accurate programming may result in sustained therapy.
Maximize practice efficiency by minimizing the need for costly fluoro or x-ray.
Source Current on each
contact on Lead 1
Measuring Stimulation Field Potentials
Measure Stimulation field potentials on all contacts on Lead 2
EGL™ Scan measures Stimulation Field Potentials
Maintain Therapy Over Time with the Precision™ Plus SCS System
Figure B
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Fluoroscopy
The fluoroscopic images (Figures A and C) show different offsets between two leads. The SmoothWave Technology (Figures B and D) detected the offsets and displayed graphical representations of the lead offsets.
Rechargeable Battery
Designed for Physician Convenience and Patient Comfort Intended to reduce pocket pain, the Precision IPG has atraumatic, rounded edges and a volume of just 22cc. And with an implant depth of up to 2 cm, the Precision IPG offers TWICE the maximum recommended implant depth of similarly sized IPGs*. But patient comfort is about more than a small size, the Precision Plus IPG is designed to offer patient satisfaction with unsurpassed innovative features.
Precision™ Plus SCS System Uses the Proprietary Lithium-Ion Zero Volt™ Battery Technology, a Significant Advance in SCS Therapy.
Designed for Reliability Precision Plus can be fully discharged or overdischargeda several times without irrecoverably damaging its battery, providing confidence that Precision Plus will operate for years to come even with noncompliant patients.
Designed for Longevity With an estimated battery life up to 25 years under certain stimulation parametersb, Precision Plus potentially will reduce the need of replacements and surgeries for your patient.
Time
Max
Before Battery Failure
Degradation or Failure
Degradation or Failure
Degradation or Failure
PRECISION™ PLUS
COMPETITOR 1
and Surgical Intervention
Actual Size
Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
The Precision™ Charger offers constant temperature monitoring to ensure safe and efficient charging. Discreet, lightweight, small and attractive – a perfect complement to Precision Plus SCS.
Designed for Reliability Built-in thermistor maintains temperature within set range improving charging efficiency and safety.
Designed for Simplicity Portable, cordless, lighweight, and small device to facilitate the charging process.
One touch operation to activate with automatic shut-off and signal to indicate the IPG charging is complete.
Technology Leadership Simplicity of use for the patient, automatic search for alignment with stimulator to ensure efficiency during the charging period.
Continuous SCS therapy and temperature monitoring while the patient charges.
* Source: Medtronic Brochure. „Recharging Systems: Restore® versus Precision®“
Medtronic Restore™ STJ Eon™Precision Plus
Medtronic Restore™ STJ Eon™Precision Plus
MOST DISCREET AND MOBILE SYSTEM AVAILABLE
COMFORTABLE AND SAFE
No Optional Yes
Yes Yes No
1: Charger, transmission coil, and large belt
1: Charger, transmission coil, and large belt
Temperature monitoring and cutoff
Not available
Yes Yes Yes
Cordless Charger: Ultimate Control for Safe Charging
1 Charger connected to antenna via cord. Sources: Medtronic Restore™ Implant Manual, 37711, 2004-08.
STJ Eon™ Clinician‘s Manual, 37-0619-01F, March 2006.
Base Station for Charger
Convenient and user-friendly remote control The Precision Remote Control provides patients with convenient wireless communication. This allows patients to simultaneously see the Remote Control screen, make changes to their stimulation and feel the changes in real-time.
In seconds, patients can turn stimulation on or off, modify the intensity of their stimulation, or change programs to adjust the areas of stimulation.
The Precision Remote Control is easy to learn and easy to use – with five large buttons and clear onscreen information. Patients can find the stimulation and program that provide the best comfort.
Only Precision™ Remote Control allows patients to make real-time adjustments over a convenient wireless range of up to 60 cm to date.
The Precision™ Remote Control is easy to use and gives patients real-time control over their own therapy.
Wireless Remote Control
Button 3: Up/Activate Down/Save
Button 4: Stimulation ON/OFF
(a) Arcos, Kramarich, Foster. The Utility of Zero-Volt Battery When Battery Charge is Depleted – Abstract of the North American Neuromodulation Society Annual Meeting, 2006 December. (b) Bradley K, Khodavirdi A, Gould B. Precision Rechargeable Spinal Cord Stimulation SCS System: Programming Parameters and Battery Longevity“– Abstract of the NeuPSIG Meeting / Berlin, 2007 June. (c) Sources for Pulse Width Chart 1. Gould B, Bradley K. Pulse Pulse Widths Programming in Spinal Cord Stimulators – Abstracts of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22.25. 2. Advanced Bionics Precision SCS System Physician Implant Manual. 3. STJ Eon Rechargeable IPG brochure, 0307-1. 4. Medtronic Restore Implant Manual, A00060002. (d) Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and
Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio.
(e) Varga C, Prager J, Krames E, Oakley J, Bradley K, Grandhe S. A New Efficient Patient-Interactive System for Programming Spinal Cord Stimulators.
Powerful and Long Lasting System
Precision Plus can deliver pulse widths up to 1.000µs to date Based on the therapy levels chosen by patients with implanted IPGs, other conventional systems may miss patient optimal coverage.c
Retrospective “chart review“ from 58 clinician programmers (467 patients)c
Pulse Width (µs)
A )
Maximum Pulse Width per Patient vs. Total Amplitude (n = 467 patients)c
0 100 200 300 400 500 600 700 800 900 1000
30
25
20
15
10
5
0
Maintain therapy over time: Longest lasting system to date*
Using a single channel stimulation program 98% of PrecisionTM IPGs would have an expected battery life of greater than 10 yearsb, and 89% would have greater than 25 years.b
Projected battery life – Retrospective “chart review“ from 58 clinician programmers (467 patients)c
Pulse Width (µs)
A )
0 100 200 300 400 500 600 700 800 900 1000
30
25
20
15
10
5
0
Maximum Pulse Width per Patient vs. Total Amplitude w/ Projected Battery Life (n = 467 patients)c
Boston Scientific Precision capabilities STJ Eon stated capabilities MDT Restore stated capabilities @ 250 MDT Restore stated capabilities @ 700 Patients: > 25 yrs (89 %) Patients: 20 – 25 yrs (3 %) Patients: 15 – 19.9 yrs (4 %) Patients: 10 – 14.9 yrs (2 %) Patients: 6.5 – 9.9 yrs (2 %)
* Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
Therapeutic Areas of Treatment
Boston Scientific is one of the world’s largest medical device companies dedicated to less-invasive therapies.
Our mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures.
This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies which can reduce risk, trauma, cost, procedure time and the need for aftercare.
The Company
Revenue: $ 7.6 billion in 2011 17 manufacturing facilities worldwide Employees worldwide: 25.000 Sales force: more than 40 countries More than 15.000 Patents issued worldwide Portfolio of more than 13.000 products
Boston Scientific
Interventional Radiology
Interventional Cardiology
© 2013 Boston Scientific Corporation or its affiliates. All rights reserved. DINNM0019ED
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Boston Scientific Precision™: Indications, contraindications and Instructions for use are included in the Instructions for Use contained in the product package. Precision™ is a registered trademark of Boston Scientific Corporation or its affiliates.
NM-58405-AA JUL 2012 Printed in Germany by medicalvision.
The Power of Multiple Independent Current Control Only the Precision Plus pulse generator has the ability to control the level of power delivered to simultaneously active contacts.*
The 16 sources that Precision Plus features, give physicians an unmatched power and flexibility in targeting complex pain syndromes, difficult to treat with conventional systems.
Impedance Happens. Precision Adjusts. Impedance varies from contact to contact at time of implant. As patient scarring occurs, impedances change over time.d Precision Plus is the ONLY SCS System that can automatically adjust to impedance changes to maintain therapy over time.d
Joystick Control There is no easier way to navigate the electrical field and resulting stimulation to the painful areas than by using a joystick. Moreover, the patient can use the joystick during programming to match paresthesia with painful areas: Patients know their pain best.
Tightly Spaced Contacts The percutaneous and surgical leads with tightly spaced contact arrays provide an excellent spatial resolution and allow for shift by 1% of electrical field which enables fine tuning the stimulation.
Bionic Navigator™
A user-friendly clinician programmer software that makes adjusting parameters of stimulation easy. It enables physicians to assess stimulation combinations at a suprathreshold level allowing for patient’s continuous feedback. Thousands of combinations e can be tested in only minutes.
SmoothWave™ Technology
Sources: Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio.
Ohms
2- w
ee ks
3- m
o n
th s
6- m
o n
th s
Im p
la n
Precisely Target Pain with the Precision™ Plus SCS System
* Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
EGL™ Scan Shows Relative Lead Position in Seconds
Only the Precision Plus SCS System offers EGL (Electronically Generated Lead) Scan™ Technology, an exciting proprietary technology that shows the relative position of two implanted leads. In conjunction with the Bionic Navigator™ software, physicians can use EGL™ Scan information to assess relative rostrocaudal lead migration.
The Precision Plus SCS System generates and measures electrical stimulation field potentials. These measurements are used to develop a spatial map that indicates the relative position of the contacts to one another. EGL Scan Technology is the only system to date that uses electrical stimulation field potentials to allow clinicians to visualize relative lead position without fluoro or x-ray.
Technology
Show relative lead position without fluoro in seconds.
In about 20 seconds, the results are displayed graphically on your Clinician Programmer.
Efficacy
Efficient and accurate programming may result in sustained therapy.
Maximize practice efficiency by minimizing the need for costly fluoro or x-ray.
Source Current on each
contact on Lead 1
Measuring Stimulation Field Potentials
Measure Stimulation field potentials on all contacts on Lead 2
EGL™ Scan measures Stimulation Field Potentials
Maintain Therapy Over Time with the Precision™ Plus SCS System
Figure B
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Fluoroscopy
The fluoroscopic images (Figures A and C) show different offsets between two leads. The SmoothWave Technology (Figures B and D) detected the offsets and displayed graphical representations of the lead offsets.
Rechargeable Battery
Designed for Physician Convenience and Patient Comfort Intended to reduce pocket pain, the Precision IPG has atraumatic, rounded edges and a volume of just 22cc. And with an implant depth of up to 2 cm, the Precision IPG offers TWICE the maximum recommended implant depth of similarly sized IPGs*. But patient comfort is about more than a small size, the Precision Plus IPG is designed to offer patient satisfaction with unsurpassed innovative features.
Precision™ Plus SCS System Uses the Proprietary Lithium-Ion Zero Volt™ Battery Technology, a Significant Advance in SCS Therapy.
Designed for Reliability Precision Plus can be fully discharged or overdischargeda several times without irrecoverably damaging its battery, providing confidence that Precision Plus will operate for years to come even with noncompliant patients.
Designed for Longevity With an estimated battery life up to 25 years under certain stimulation parametersb, Precision Plus potentially will reduce the need of replacements and surgeries for your patient.
Time
Max
Before Battery Failure
Degradation or Failure
Degradation or Failure
Degradation or Failure
PRECISION™ PLUS
COMPETITOR 1
and Surgical Intervention
Actual Size
Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
The Precision™ Charger offers constant temperature monitoring to ensure safe and efficient charging. Discreet, lightweight, small and attractive – a perfect complement to Precision Plus SCS.
Designed for Reliability Built-in thermistor maintains temperature within set range improving charging efficiency and safety.
Designed for Simplicity Portable, cordless, lighweight, and small device to facilitate the charging process.
One touch operation to activate with automatic shut-off and signal to indicate the IPG charging is complete.
Technology Leadership Simplicity of use for the patient, automatic search for alignment with stimulator to ensure efficiency during the charging period.
Continuous SCS therapy and temperature monitoring while the patient charges.
* Source: Medtronic Brochure. „Recharging Systems: Restore® versus Precision®“
Medtronic Restore™ STJ Eon™Precision Plus
Medtronic Restore™ STJ Eon™Precision Plus
MOST DISCREET AND MOBILE SYSTEM AVAILABLE
COMFORTABLE AND SAFE
No Optional Yes
Yes Yes No
1: Charger, transmission coil, and large belt
1: Charger, transmission coil, and large belt
Temperature monitoring and cutoff
Not available
Yes Yes Yes
Cordless Charger: Ultimate Control for Safe Charging
1 Charger connected to antenna via cord. Sources: Medtronic Restore™ Implant Manual, 37711, 2004-08.
STJ Eon™ Clinician‘s Manual, 37-0619-01F, March 2006.
Base Station for Charger
Convenient and user-friendly remote control The Precision Remote Control provides patients with convenient wireless communication. This allows patients to simultaneously see the Remote Control screen, make changes to their stimulation and feel the changes in real-time.
In seconds, patients can turn stimulation on or off, modify the intensity of their stimulation, or change programs to adjust the areas of stimulation.
The Precision Remote Control is easy to learn and easy to use – with five large buttons and clear onscreen information. Patients can find the stimulation and program that provide the best comfort.
Only Precision™ Remote Control allows patients to make real-time adjustments over a convenient wireless range of up to 60 cm to date.
The Precision™ Remote Control is easy to use and gives patients real-time control over their own therapy.
Wireless Remote Control
Button 3: Up/Activate Down/Save
Button 4: Stimulation ON/OFF
(a) Arcos, Kramarich, Foster. The Utility of Zero-Volt Battery When Battery Charge is Depleted – Abstract of the North American Neuromodulation Society Annual Meeting, 2006 December. (b) Bradley K, Khodavirdi A, Gould B. Precision Rechargeable Spinal Cord Stimulation SCS System: Programming Parameters and Battery Longevity“– Abstract of the NeuPSIG Meeting / Berlin, 2007 June. (c) Sources for Pulse Width Chart 1. Gould B, Bradley K. Pulse Pulse Widths Programming in Spinal Cord Stimulators – Abstracts of the American Academy of Pain Medicine 22nd Annual Meeting, 2006 February 22.25. 2. Advanced Bionics Precision SCS System Physician Implant Manual. 3. STJ Eon Rechargeable IPG brochure, 0307-1. 4. Medtronic Restore Implant Manual, A00060002. (d) Oakley J, Prager J, Krames E, Weiner R, Stamatos J, Bradley K. Variability of Contact Impedance Over Time in Spinal Cord Stimulation. Abstracts of the American Society of Stereotactic and
Functional Neurosurgery Biennial Meeting, Neuromodulation: Defining the Future, 2004 October 1-3. Cleveland, Ohio.
(e) Varga C, Prager J, Krames E, Oakley J, Bradley K, Grandhe S. A New Efficient Patient-Interactive System for Programming Spinal Cord Stimulators.
Powerful and Long Lasting System
Precision Plus can deliver pulse widths up to 1.000µs to date Based on the therapy levels chosen by patients with implanted IPGs, other conventional systems may miss patient optimal coverage.c
Retrospective “chart review“ from 58 clinician programmers (467 patients)c
Pulse Width (µs)
A )
Maximum Pulse Width per Patient vs. Total Amplitude (n = 467 patients)c
0 100 200 300 400 500 600 700 800 900 1000
30
25
20
15
10
5
0
Maintain therapy over time: Longest lasting system to date*
Using a single channel stimulation program 98% of PrecisionTM IPGs would have an expected battery life of greater than 10 yearsb, and 89% would have greater than 25 years.b
Projected battery life – Retrospective “chart review“ from 58 clinician programmers (467 patients)c
Pulse Width (µs)
A )
0 100 200 300 400 500 600 700 800 900 1000
30
25
20
15
10
5
0
Maximum Pulse Width per Patient vs. Total Amplitude w/ Projected Battery Life (n = 467 patients)c
Boston Scientific Precision capabilities STJ Eon stated capabilities MDT Restore stated capabilities @ 250 MDT Restore stated capabilities @ 700 Patients: > 25 yrs (89 %) Patients: 20 – 25 yrs (3 %) Patients: 15 – 19.9 yrs (4 %) Patients: 10 – 14.9 yrs (2 %) Patients: 6.5 – 9.9 yrs (2 %)
* Testing was performed by or on behalf of BSC, the data are on file at BSC and will be made available upon request
Therapeutic Areas of Treatment
Boston Scientific is one of the world’s largest medical device companies dedicated to less-invasive therapies.
Our mission is to improve the quality of patient care and the productivity of health care delivery through the development and advocacy of less-invasive medical devices and procedures.
This is accomplished through the continuing refinement of existing products and procedures and the investigation and development of new technologies which can reduce risk, trauma, cost, procedure time and the need for aftercare.
The Company
Revenue: $ 7.6 billion in 2011 17 manufacturing facilities worldwide Employees worldwide: 25.000 Sales force: more than 40 countries More than 15.000 Patents issued worldwide Portfolio of more than 13.000 products
Boston Scientific
Interventional Radiology
Interventional Cardiology
© 2013 Boston Scientific Corporation or its affiliates. All rights reserved. DINNM0019ED
All cited trademarks are the property of their respective owners. CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for the use only in countries with applicable health authority product registrations. Boston Scientific Precision™: Indications, contraindications and Instructions for use are included in the Instructions for Use contained in the product package. Precision™ is a registered trademark of Boston Scientific Corporation or its affiliates.
NM-58405-AA JUL 2012 Printed in Germany by medicalvision.
