SynchroMed™ III Implantable infusion system

SynchroMed™ III is an implantable targeted drug infusion system that helps manage chronic pain, cancer pain, and severe spasticity.

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Overview


Simple, safe and effective intrathecal therapy made possible


Unlike medications that must be absorbed systemically and must cross the blood-brain barrier, an implanted SynchroMed™ III programmable pump and catheter deliver prescribed amounts of medication directly into the intrathecal space.

Targeted drug delivery (TDD) into the intrathecal space offers effective relief at a fraction of the systemic dose, which can reduce side effects.1-3

Targeted Drug Delivery Compared to Systemic Delivery with Oral Medication


The SynchroMed™ III implantable infusion system provides:

  • State-of-the-art pump electronics to enable enhanced long-term reliability and wireless firmware upgradability to facilitate expanded capabilities
  • End-to-end cybersecurity controls for enhanced patient data protection
  • Refill-only workflow, which enables a shorter and more consistent update duration during this common clinician device interaction
  • Continued peace of mind with proven durable design enhancements built into the SynchroMed™ II pump, which have increased pump survival rate to 99%.*


Product details

SynchroMed™ III is an upgraded system compared to the SynchroMed™ II system, featuring a new “refill only” physician workflow for more efficient programming, improved electronics capable of delivering firmware upgrades to implanted devices, and additional protections for patient data through enhanced cybersecurity.

 Allows full-body 1.5 and 3T MRI scans under specific conditions  
 

Updated electronics

New chipset and firmware allow end-to-end cybersecurity controls and an upgradable platform.

Updated programming

Refill-only workflow enables a shorter and more consistent update duration.

Proven performance

Reliability by design with proven durable design enhancements from SynchroMed™ II infusion pump

SynchroMed™ III targeted drug infusion system


 

battery coating

2011

Battery coating
added 
Gearwheel

2015

Gearwheel 3 material change added  
Feedthroughs

2015

Feedthroughs encapsulated
added 
DLC coating

2017

Diamond-like carbon (DLC) coating added 


 


Enhanced for reliability

Let the data do the talking

Pump survival rate over time*

Survival rate


Simple, safe & effective, offering valuable time with their loved ones, for patients with refractory cancer pain.

Simple

Easier Programming for clinicians with the refill-only workflow.28

Automatic drug delivery reduces therapy burden and offers personalised treatment fitting patients’ lifestyle.5, 29

Safe

More patients with
reduced side effects.1,2,5,6

Effective

More patients with
increased pain control.1,2,5,6


Simple, safe & effective, improving care and function in patients with severe spasticity

Simple

Easier Programming for clinicians with the refill-only workflow.28

Automatic drug delivery reduces caregiver burden and offers personalised treatment fitting patients’ lifestyle.9, 10, 29

Safe

Fewer or more tolerable side effects are expected compared to oral medication.11

Effective

ITB Therapy can help improve function, activities of daily living, and ease of care.12-14


Patient satisfaction 

Chronic pain

90% 

of patients would recommend the therapy to a family member or friend.4

Cancer pain

94% 

reduction in systemic opioid.7

Spasticity

99% 

of severe spasticity patients
choose to replace the pump at the
end of battery life.8


Ordering information

Item Description
SynchroMed™ III pump (8667-20 and 8667-40)  SynchroMed™ III pump with 20 mL and 40 mL reservoir capacities both redesigned with new electronics and firmware (upgradability and cybersecurity). 
SynchroMed™ Clinician Programmer CT900 tablet with A810 software v2.x  Clinician programmer with the new refill-only workflow that streamlines clinician programming. 
TH90T02 patient programmer with A810 software v2.x  myPTM™ Personal Therapy Manager with added information intended to better support patient understanding of clinician restrictions for patient bolus activation. 
 

Education & training


Learn more about spinal cord stimulation therapy for chronic pain.

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information

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*

This data represents pumps with four durable design changes (battery coating, gear wheel 3 material change, feedthrough encapsulation, diamond-like carbon coating). The most recent design change was implemented in 2017. At four years, the survival probability (95% confidence intervals) was 97% pump survival rate pre-enhancements (n=3158 pumps) and 99.4% post-durable enhancements (n=203 pumps). Source: 2022 Product Performance Report.

MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions: https://manuals.medtronic.com/manuals/mri/region

1

Hamza, M et al. Pain Medicine. (United States) 13, 1304–1313 (2012). doi: 10.1111/j.1526-4637.2012.01451.x

2

Smith, TJ et al. Journal of Clinical Oncology. 20, 4040–4049 (2002). doi: 10.1200/JCO.2002.02.118

3

Rushton, DN. Upper Motor Neurone Syndrome and Spasticity: Chapter 10. ed. Barnes, MP and Johnson, GR pages 181–192. (Cambridge University Press, 2008). doi:10.1017/cbo9780511544866.011.

4

Deer, T et al. Pain Medicine. doi: 10.1111/j.1526-4637.2004.04011.x 

5

Smith TJ, Coyne PJ. J Palliat Med. 2005;8(4):736–742. doi: 10.1089/jpm.2005.8.736 

6

Grider JS, Etscheidt MA, Harned ME, et al. Neuromodulation. 2016;19(2):206-219. doi:10.1111/ner.12352. 

7

Sindt et al. Neuromodulation. 2020; 23(7):978-983. doi: 10.1111/ner.13175 

8

Schiess MC, Eldabe S, Konrad P, et al. Neuromodulation. 2020;23(7):996-1002. doi:10.1111/ner.13097.

9

Meythaler JM, McCary A, Hadley MN. J Neurosurg. 1997;87(3):415-419. doi: 10.3171/jns.1997.87.3.0415 

10

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11

Ertzgaard P, Campo C, Calabrese A. J Rehabil Med. 2017 Mar 6;49(3):193-203. doi: 10.2340/16501977-2211 

12

Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Arch Phys Med Rehabil. 2006;87(11):1509–1515. doi: 10.1016/j.apmr.2006.08.323 

13

Dario A, Scamoni C, Bono G, et al. Funct Neurol. 2001;16:311-315. PMID: 11853321 

14

Krach LE, Nettleton A, Klempka B. Pediatr Rehabil. 2006;9(3):210-218. doi: 10.1080/13638490500138678 

15

Borrini L, Bensmail D, Thiebaut JB, Hugeron C, Rech C, Jourdan C. Arch Phys Med Rehabil. 2014;95(6):1032-1038. doi:10.1016/j.apmr.2013.12.019.  

16

Copley S, Yassa PE, Batterham AM, et al. Neuromodulation. 2023;26(6):1240-1246. doi:10.1016/j. neurom.2022.10.05. 

17

Brogan SE, Winter NB, Okifuji A. Reg Anesth Pain Med. 2015;40(4):369–75. doi: 10.1097/AAP.0000000000000251 

18

Vles GF, Soudant DL, Hoving MA et al. Eur J Paediatr Neurol. 2013;17(6):639-644. doi: 10.1016/j.ejpn.2013.06.003 

19

Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Becher JG, Vles JS. Eur J Paediatr Neurol. May 2009;13(3):240-246. doi: 10.1016/j.ejpn.2008.04.013 

20

Francisco GE, Boake C. Arch Phys Med Rehabil. 2003;84(8):1194-1199. doi: 10.1016/s0003-9993(03)00134-5 

21

Nanninga JB, Frost F, Penn R. J Urol. 1989;142:101- 105. doi: 10.1016/s0022-5347(17)38673-1 

22

Sadiq SA, Wang GC. J Neurol. 2006;253(5):563-569. doi: 10.1007/s00415-005-0060-4 

23

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24

Melthaler JM, McCary A, Hadley MN. J Neurosurg. 1997;87(3):415-419. doi: 10.3171/jns.1997.87.3.0415 

25

Creamer M, Cloud G, Kossmehl P, et al. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650. doi: 10.1136/jnnp-2017-17021.  

26

Penn RD, Savoy SM, Corcos D, et al. N Engl J Med. 1989; 320: 1517-1521. doi: 10.1056/NEJM198906083202303 

27

Breivik H, Cherny N, Collett B, et al. Ann. Oncol. 20 1420–33. doi: 10.1093/annonc/mdp001 

28

NDHF1593-220433, SynchroMed X Clinician Programming Marketing Claims Characterization Test Report [SMII: 44.1sec, SMIII: 5.6sec (statistically significant: tighter standard deviation for SMIII]

29

SynchroMed™ A810 Clinician Programmer Application Clinician Programming Guide M968017A035 Rev A. Published online August 15, 2022. Accessed July 4, 2024. https://manuals.medtronic.com/