Medtronic Begins Post-Market, Real-World Study of the InterStim™ Micro System

RAYUS Radiology Quality Institute Distinguished Nationally by Centers for Medicare & Medicaid

Quality Institute Again Earns Certification as Provider-Led Entity for Advanced Diagnostic Imaging Guidance to Clinicians.

LX1550 Multiparameter Remote Monitoring Platform Receives FDA 510 (k) Approval: Reports LifeSignals

Further validation of ability to deliver continuous remote patient vital signs monitoring within both hospital and home settings.

U.S. News & World Report Names Tampa General Hospital as Best in Tampa Bay

This is the sixth consecutive year that Tampa General has been named by U.S. News & World Report as Tampa Bay's top hospital.

Medtronic plc today announced it has begun recruitment of the prospective, multicenter, global, post-market study of the InterStim™ Micro system for sacral neuromodulation (SNM) therapy. Medtronic announced approval from the U.S. Food and Drug Administration for the InterStim Micro neurostimulator on August 3, 2020, and CE Mark on January 13, 2020.

“SNM therapy is already proven to be safe and effective, but we expect the ELITE study to definitively reinforce established SNM evidence in patients implanted with the new InterStim Micro system,” said Victor Nitti, M.D., the Shlomo Raz Chair in urology, professor of urology and obstetrics and gynecology, and chief and fellowship director of Female Pelvic Medicine and Reconstructive Surgery at the David Geffen School of Medicine at UCLA. “We hope the results of the study will encourage even more patients suffering from incontinence to pursue SNM therapy.”

More than 37 million adults in the United States — almost one in six — suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans — about one in 12 — have bowel incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally5; however, as many as 45% who suffer from symptoms do not seek treatment.6

The Evaluation of InterStim Micro System Performance and Safety (ELITE) study will enroll 160 subjects with overactive bladder (OAB), fecal incontinence (FI) and non-obstructive urinary retention (NOUR) — the most indications of any other study on the market — across 40 sites in the United States (and United States Territories), Europe, Australia and Canada. Objectives include patient reported outcomes, disease specific quality of life questionnaires, and symptom diaries. Patients will be followed for two years.

“By initiating ELITE, Medtronic reinforces its long-standing commitment to SNM therapy,” said Brooke Story, vice president and general manager of the Pelvic Health & Gastric Therapies business, which is part of the Restorative Therapies Group at Medtronic. “In partnership with physicians, we developed SNM therapy more than 25 years ago, and the InterStim system is the gold standard in the industry. Our SNM technology is backed by the only existing 5-year clinical data on the market for all SNM indications, and we expect the ELITE study will fortify the established evidence.”


References:

1 Stewart WF, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-336.

2 United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.

3 Whitehead WE, Borrud L, Goode PS, et al. Pelvic floor disorders network. Fecal incontinence in US adults: epidemiology and risk factors. Gastroenterology. 2009;137: 512-517.

4 United States Quick Facts. United States Census Bureau Web site. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. Accessed July 19, 2016.

5 Dmochowski RR, Newman DK. Impact of overactive bladder on women in the United States: results of a national survey. Current Medical Research and Opinion. 2007;23:65-76.

6 Leede Research, “Views on OAB: A Study for the National Association of Continence.” December 16, 2015.

 

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.