|New Study Demonstrates Superior Clinical and Quality of Life Benefits of Medtronic Sacral Neuromodulation Compared to Standard Medical Treatment for Overactive Bladder at Six Months|
InSite Study Results Show Efficacy and Quality of Life Advantages with InterStim® System
MINNEAPOLIS – October 4, 2012 – The first-ever study to compare the clinical benefits of Medtronic, Inc. (NYSE: MDT) sacral neuromodulation (SNM) with standard medical treatment (oral medication) in less-severe overactive bladder (OAB) patients – defined as those failing at least one previous OAB medication – found SNM, delivered by the Medtronic InterStim® system, to be associated with superior efficacy and quality of life (QOL) versus medication alone.1,2 Results of the study, which represents a less-severe segment of SNM eligible subjects than have been previously studied in a multicenter trial, were presented today at the American Urogynecologic Society (AUGS) annual scientific meeting in Chicago.
An intent-to-treat analysis of results at six months found that 61 percent of patients who received sacral neuromodulation (n=70) reported significant improvement in OAB symptoms (≥50 percent improvement in average leaks/day, or ≥50 percent improvement in voids/day, or a return to normal voiding frequency [<8 voids/day]) compared to 42 percent of patients who received standard medical treatment (n=77, p<0.05).
Favorable results were also reported by patients in the as-treated population, which compared the responses of patients actually receiving the Medtronic InterStim system (n=51) to those receiving standard medical treatment (n=73). A significantly greater therapeutic OAB success rate was reported in 76 percent of as-treated study participants with SNM delivered via the InterStim system compared with 49 percent of patients receiving standard medical treatment (p<0.01).
Results also showed that 71 percent of as-treated SNM subjects with urinary urge incontinence (n=38) reported improvement in OAB symptoms (≥50 percent improvement in average leaks/day), while 47 percent of subjects treated with SMT (n=57) showed improvement (p<0.05). Complete urinary continence was achieved in 40 percent of SNM subjects and 21 percent of SMT subjects. Of the study participants with urgency-frequency issues, 61 percent of SNM subjects (n=33) achieved normal voiding patterns (<8 voids/day) compared to 37 percent in the SMT group (n=46, p<0.05).
Additionally, an as-treated analysis of an OAB quality of life questionnaire showed that patients receiving SNM had significantly greater improvements in OAB quality of life at six months compared to SMT, including levels of concern, coping ability, sleep habits, social functioning, total health-related quality of life and a measure of how much urinary symptoms interfere with everyday activities (all p<0.001). Average improvement in the total health-related quality of life score at six months in SNM was more than three times greater than that in SMT (40.1 vs. 12.5).
The prospective, multicenter, post-approval study included patients with bothersome OAB symptoms, including urinary urge incontinence or urgency-frequency, who had unsuccessfully used at least one OAB medication. For this analysis, 147 study patients were randomized to receive either sacral neuromodulation (n=70) or standard medical treatment with OAB medication (n=77). Of the 70 patients in the SNM group, 51 had the InterStim system implanted after undergoing successful test stimulation. SNM trial participants were not allowed to take any OAB medications.
“The InterStim system is a well-established treatment option for patients with refractory overactive bladder symptoms, and this study confirms the therapy is effective,” said Steven Siegel, M.D., InSite study lead investigator and director of the Metro Urology Centers for Female Urology and Incontinence in Woodbury, MN. “These results also show that the InterStim system provides significant quality of life improvements in less-severe overactive bladder patients than previously studied.”
To date, more than 125,000 people worldwide have received Medtronic’s InterStim system. The system delivers mild electrical pulses to the sacral nerves through a thin wire lead and a neurostimulator about the size of a stopwatch, which is implanted under the skin in the lower back near where the sacral nerves are located. The therapy is reversible – the system can be turned off or surgically removed at any time – and it is FDA approved for MRI head scans under specific conditions.3 After an extensive clinical evidence review, sacral neuromodulation was recently labeled a “recommendation” for refractory idiopathic OAB patients by the American Urological Association’s OAB Guidelines Panel, based on evidence that the clinical benefits outweigh the risks.
“The InSite study results are an important input into the growing body of evidence about the standard of care for overactive bladder management,” said Cindy Kent, vice president and general manager, gastro/urology therapies at Medtronic. “The data clearly demonstrate that InterStim therapy is effective in helping patients manage their symptoms and enjoy their lives.”
In safety analysis, 23.7 percent of patients randomized to receive sacral neuromodulation had device-related adverse events and 26.0 percent of patients randomized to receive standard medical therapy had OAB medication-related adverse events. The most common device-related adverse events were implant site pain (8.5 percent), lead migration (3.4 percent) and infection (3.4 percent). Researchers reported a low incidence of serious adverse events: 7.8 percent for sacral neuromodulation and 5.3 percent for standard medical therapy. There were no unanticipated device-related adverse events and there were no differences between the two groups for any individual adverse event or for any serious adverse events.
Additional information about Medtronic sacral neuromodulation with the InterStim system can be found at www.everyday-freedom.com.
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Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission.
Justin Ihle, Public Relations, 1-763-526-0911
Jeff Warren, Investor Relations, 763-505-2696