STATEMENT AND Q&A FROM BOSTON SCIENTIFIC REGARDING SPINAL CORD STIMULATORS

NEWS CENTER Maine (NCM) sent a list of questions to Boston Scientific (BS) and these were their responses:

Boston Scientific statement

“We cannot comment on the specifics of any patient’s case without their express consent, but are
saddened when any patient with one of our products does not have a positive experience.

“At Boston Scientific, it is our privilege to provide safe and effective products and therapies that touch the
lives of more than 30 million patients around the world each year. Boston Scientific has a strong safety
record, with an average annual complaint rate across our entire product range of less than 0.15%, and an
even lower rate of adverse events.

“Chronic pain is an inherently difficult condition to treat, and the decision to pursue any particular therapy
needs to be made carefully between patients and their doctor. SCS therapy is unique in that it allows the
patient to try the therapy before they decide on the final implant. This means one SCS implant could have
two procedures associated with it, the trial and the permanent implant. The first procedure, approximately
a 1 week trial, allows the patient to evaluate the therapy and carefully determine with their doctor if the
benefit for them is worth moving forward with the permanent procedure.

“Our spinal cord stimulators have offered long-term pain relief to more than 150,000 people since their
introduction in 2004. While we can’t completely eliminate risk when complex technologies and patient
conditions are involved, we aim to have the lowest possible rate of adverse events associated with our
products, and never stop working to further improve the safety and effectiveness of our devices – all with
the end goal of improving the lives of the patients we treat.”

NCM: According to the FDA spinal cord stimulators account for the third highest number of medical
device injuries, 80-thousand adverse reports since 2008. Of that number how many of these reports
involved spinal cord stimulators manufactured by Boston Scientific?

BS: The 80,000 figure in the FDA database (MAUDE) lacks the information needed to determine how
involved, if at all, a medical device is in a patient’s adverse event. For that reason, the FDA has cautioned
that reporting captured in that database “cannot be used to establish rates of events, evaluate a change in
event rates over time or compare event rates between devices,” and “cannot be interpreted or used in
isolation to reach conclusions about the existence, severity, or frequency of problems associated with
devices.”

BS: There are many events in the MAUDE database that are grouped in a broad category called “injuries.”
Boston Scientific includes in reportable “injuries” not only those that are permanent, but those that may be
temporary or reversible with moderate medical or surgical intervention. Situations in this category may
include reversible infections or discomfort at the implant site that require prescription or even over-the-
counter medication. In our internal quality assessments, over 95% of the injury reports were temporary or
reversible in nature. Many of the events are related to surgical procedure or post-operative care, which are
known complications and outlined in the directions for use information provided to the physicians and
patients.

NCM: What do you offer patients who are experiencing pain, flare ups and other health problems they
believe is connected to the spinal cord stimulator manufactured by Boston Scientific?

BS: We have a dedicated customer care center and on-site clinical support teams that are devoted to
helping patients who need technical assistance for their implantable device and related patient
accessories. Our teams do not provide medical or therapy advice as these decisions are made between
the patient and their physician.
NCM: What is the safety record for spinal cord stimulators manufactured by Boston Scientific since it
went onto the market in 2004?
BS: The safety and effectiveness of our spinal cord stimulation products are supported by multiple clinical
studies [i],[ii],[iii],. [iv],[v], [vi] These studies demonstrate effective long-term pain relief and a low rate of adverse
events for SCS when implanted appropriately.

•
In a recent study, about 90% of patients implanted with a Boston Scientific SCS device for an
average of four years reported they were “better” or a “great deal better” as a result of their SCS
therapy.i
•
Our newest SCS system is the first FDA-approved device which can deliver both paresthesia and
paresthesia-free therapy at the same time, allowing patients to customize their stimulation. One
clinical trial found that if patients are able to choose between paresthesia and paresthesia-free
therapies, the number of patients whose pain was effectively controlled by SCS therapy increased
by 62 percent.i
•
A real-world study of more than 200 patients using the latest Boston Scientific SCS system at the
last follow-up (mean 3 months), reported a 5.2-point drop in a patient’s pain score on a 10-point
pain score scale. Further, about 40% of these patients also reported greater than 80% pain relief.vi

NCM: Do you work with a patient’s doctor to help find other options, pain management when they
experience pain and other symptoms following the implantation of the spinal cord stimulator?

BS: Our dedicated customer care center and on-site clinical support teams provide technical support
requested by physicians. Our teams do not provide medical or therapy advice as these decisions are made
between the patient and their physician.

Boston Scientific has a toll-free number for patients to call: 1-866-360-4747

[i]
North J. WHISPER: A Multicenter, Prospective Randomized Controlled Crossover Trial Evaluating Subperception SCS at ≤ 1.2 kHz. NANS 21st
Annual Meeting, January 11–14, 2018, Las Vegas, NV.
[ii]
Thomson S.J., Tavakkolizadeh M., Love-Jones S., Patel N.K., Gu J.W., Bains A., Doan Q., Moffitt M. 2018. Effects of Rate on Analgesia in
Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation 2018; 21: 67–76North JM,
Hong KJ, Cho PY.
[iii]
Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation in Implanted Patients With Failed Paresthesia-Based Stimulation: Results of
a Prospective Randomized Controlled Trial. Neuromodulation. 2016 Oct;19(7):731-737.
[iv]
Thomson S.J., Kruglov D., Duarte R.V. 2017. A Spinal Cord Stimulation Service Review From a Single Centre Using a Single Manufacturer Over
a 7.5 Year Follow-Up Period. Neuromodul ation 2017; 20: 589–599.
[v]
Veizi E, Hayek SM, North J, et al. Spinal cord stimulation (SCS) with anatomically guided (3D) neural targeting shows superior chronic axial low
back pain relief compared to traditional SCS-LUMINA study. Pain Med 2017;18(8):1534–48.
[vi]
Metzger C. Outcomes Using an SCS Device Capable of Delivering Combination Therapy (Simultaneous or Sequential) and Advanced
Waveforms/Field Shapes. 1st Joint Congress of the European INS Chapters. September 19–22, 2018, Nijmegan, The Netherlands.