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Precision SCS · 1 trial · 5 indications
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
| Arm | Type | Description |
|---|---|---|
| Precision SCS | EXPERIMENTAL | Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system |
| Name | Type | Description |
|---|---|---|
| Precision SCS | DEVICE | Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. |
Inclusion Criteria: 1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain. 2. Be an appropriate candidate for...
Precision SCS is an implantable spinal cord stimulation pain management system developed by Boston Scientific Corporation for the treatment of chronic pain, including intractable pain, back pain, and failed back surgery syndrome. It is an investigational device that has completed a Phase 3 clinical trial.
Precision SCS is developed by Boston Scientific Corporation, a medical device company traded on the New York Stock Exchange under the ticker symbol BSX. The company conducted a Phase 3 clinical trial of the device for chronic pain management.
Precision SCS is in Phase 3 clinical development. A Phase 3 trial of the implantable spinal cord stimulation system has been completed. The device is investigational and has not been reported as FDA approved.
Precision SCS has one completed Phase 3 clinical trial, identified as NCT00205855, titled 'An Implantable Spinal Cord Stimulation Pain Management System.' The trial enrolled 65 participants in the United States with chronic pain conditions, including back pain and failed back surgery syndrome.
The Phase 3 clinical trial of Precision SCS, NCT00205855, was not randomized and did not use a control group. It was an uncontrolled study that enrolled 65 participants with chronic pain in the United States.