Healthcare Professionals

SynchroMed II Drug Infusion System

Targeted Drug Delivery

Overview

Medtronic SynchroMed™ II pump and catheter are part of an implantable, programmable drug infusion system that stores and delivers medication into the intrathecal space. Combined with the Control WorkflowSM, we are working to eliminate systemic opioids and provide effective pain relief.1

We pursue future innovations to help simplify therapy delivery.

  • The latest Clinician Programmer features simple, visual, and intuitive workflows to help simplify the programming experience.
  • The refreshed myPTM™ Personal Therapy Manager features a simple, patient-friendly design. You can help your patients alleviate their unpredictable pain without systemic opioids.2
  • We improved the design and performance of the SynchroMed™ II pump by completing the implementation of four design changes in 2017.3 We have an unwavering commitment to precision and accuracy.

INDICATIONS

Within the United States:

  • The chronic intrathecal infusion of Infumorph™ (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain.
  • The chronic intrathecal infusion of Prialt® (preservative-free ziconotide sterile solution) for the management of severe chronic pain.

PRODUCT DETAILS

SYNCHROMED II CLINICIAN PROGRAMMER

SYNCHROMED II CLINICIAN PROGRAMMER
  • Tablet with touchscreen interface compatible with the SynchroMed™ II pump 
  • Helpful workflow guides and simple steps for refill and implant 
  • Built-in auto-calculations for volume and rates 
  • Visuals accompany prime bolus and flex dosing to help simplify the process 
  • Communicator and the programmer are designed to wirelessly connect enabling flexible and comfortable delivery of patient care within 3 meters

myPTM PERSONAL THERAPY MANAGER

myPTM Personal Therapy Manager is part of a programmable drug infusion system.
  • Empower your patients to alleviate their unpredictable pain without the use of systemic opioids.2
  • myPTM™ lets you to set a therapeutic daily dose and allow your patients on-demand bolusing within limits.
  • Proven satisfaction — patients experience higher levels of therapy satisfaction with a myPTM4
  • Visual, simple and intuitive — myPTM™ screens feature clear and informative bolus confirmations, lockout details, and alerts.
  • Easy and simple to use.3

Benefits of the SynchroMed II Pump

  • Flex dosing schedules allow drug delivery to be matched to patient needs, providing chronic pain relief throughout the day
  • Precise dose titration enables clinicians to prescribe the lowest dose to reach patient goals

SAFETY

  • Smart software guides the clinician through programming the system, via information and warning screens
  • Full-body MRI compatibility at 1.5 and 3-Tesla under specific conditions*
  • Critical alarms are triggered at end of service, if a motor stall is detected, critical pump memory error, tube set interval, or if an empty reservoir is estimated
  • Noncritical alarm sounds for the elective replacement indicator, noncritical pump memory error, or a low reservoir is estimated

CONVENIENCE

  • Critical therapy and patient data stored in the pump allow flexibility for follow-up at other institutions
  • 180-day drug stability for Infumorph™
  • Clinician programmer features a vibrant touchscreen display, visuals, and workflow guides
  • The communicator is placed over the pump and is designed to wirelessly connect within 3 meters of the clinician programmer

How SynchroMed II WORKS

The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed II pump reservoir. At normal body temperatures, pressurized gas that is stored below the reservoir expands, exerting constant pressure on the reservoir. This pressure advances the drug into the SynchroMed II pump tubing.

The peristaltic action of the SynchroMed II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site.

The catheter access port (CAP) allows injection of the drug directly into the implanted catheter for drug administration and diagnostic purposes. Drug injected into the CAP bypasses the SynchroMed II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site.

Ports and suture loops on the SynchroMed II infusion pump

Real-World Data Helps Fuel Innovation

We actively monitor the performance of our products through the Product Performance Registry. 

  • Insights are collected from more than 7,900 patients at over 60 centers worldwide creating a robust view of trends.5
  • Monitor and investigate complaints and complaint trends.
  • Data analysis helps drive product enhancements and innovations.

Industry-Leading MRI workflow

Implanting the SynchroMed II infusion pump under the appropriate conditions will not restrict patients from receiving a full-body MRI scan. The SynchroMed II infusion system allows safe full-body access to 1.5 and 3.0-Tesla MRI.* The pump is designed to resume programmed therapy after the scan.


OTHER COMPATIBLE PRODUCTS

Ascenda catheter

ASCENDA CATHETER

  • Available in 2 lengths
  • Flexible and trimmable
  • Unique four-layer construction for compression resistance
  • Sutureless connector

MANUALS AND TECHNICAL GUIDES

Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. Search by the product name (SynchroMed) or model number (8637).


SynchroMed Pump MODEL SPECIFICATIONS

Model 8637-20 (20 mL reservoir) 8637-40 (40 mL reservoir)
Battery Life 4 to 7 years 4 to 7 years
Minimum flow rate 0.048mL/day 0.048mL/day

*

MR Yellow Triangle  Under specific conditions for 1.5 T and 3.0 T MRI scans. Requires interrogation to confirm pump status.

Requires interrogation to confirm pump status.


1

Hatheway JA, et al. Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures. Neuromodulation. 2015 Apr;18(3):207-13.

2

Bolash, Niazi, Kumari, Azer, Mekhail. Pain Pract. Efficacy of a Targeted Drug Delivery on-Demand Bolus Option for Chronic Pain. 2018 Mar;18(3):305-313. 

3

Medtronic data on file.

4

Ilias W, le Polain B, Buchser E, Demartini L. Patient-controlled analgesia in chronic pain patients: experience with a new device designed to be used with implanted programmable pumps. Pain Pract. 2008;8(3):164-170. 

5

Product Performance Report 2017