38 English Inspire System Models 3024, 4063, 4323
200-079-101 Rev A
3024EN_ch.fm 5/6/14 10:31 pm
4.625 x 6 inches (117 mm x 152 mm)
Inspire Medical Confidential
Study Results
Titration
All subjects underwent polysomnography (PSG) for titration of therapy settings at 2 and 6
months. Additional titration PSG studies were performed as needed. Through 18 months,
patients had an average of 3.3 (range 2–6) titration studies.
Safety
Of the 126 patients implanted with the Inspire UAS system in the STAR trial, 124 were followed
through 18 months. There were no unanticipated events and only 2 events required surgical
intervention. Both events consisted of an IPG migrating out of position and were resolved with
a surgical procedure performed under local anesthesia to reposition the IPG.
Many of the procedure-related adverse events reported are expected with a surgical procedure.
The procedure-related events are described in Table 4.
Table 4. Procedure-Related Adverse Events
(and the probability of experiencing them in the first 18 months)
Event Number of Subjects
with Event
Percent of Subjects
(n=126)
Incision pain 35 28%
Post-operative discomfort 31 25%
Temporary tongue weakness 23 18%
Sore throat from intubation during
implant
15 12%
Other post-operative symptoms
(such as gastrointestinal (nausea,
vomiting, abdominal pain,
constipation), body pain (back,
knee, wrist, hand), allergy to
antibiotics, anxiety, ineffective
airway clearance, loss of some
taste, inability to void)
14 11%
Headache 8 6%
Mild infection 1 1%
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