Investigational Medical Device

Known as: Investigational Device 
A device that is the subject of clinical investigation or research to determine the safety or effectiveness of the device. Investigational devices… (More)
National Institutes of Health

Papers overview

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Review
2016
Review
2016
Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized…
OBJECTIVE The purpose of this study was to report the outcome of a study of 2-level cervical total disc replacement (Mobi-C… (More)
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2013
2013
Early report from an investigator-initiated investigational device exemption clinical trial on physician-modified endovascular grafts.
OBJECTIVE To determine whether a physician-modified endovascular graft (PMEG) is a safe and effective method for treating… (More)
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2012
2012
Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.
Between May 2001 and June 2004, 388 total knee arthroplasty cases were enrolled in a prospective, randomized, multicenter… (More)
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Highly Cited
2011
Highly Cited
2011
Lumbar disc arthroplasty with Maverick disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial.
STUDY DESIGN Randomized, controlled, multicenter, investigational device exemption trial. OBJECTIVE To investigate the safety… (More)
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2010
2010
THA with Delta ceramic on ceramic: results of a multicenter investigational device exemption trial.
UNLABELLED Although the published studies on the outcomes of total hip arthroplasty (THA) performed with currently available… (More)
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2010
2010
Prospective study of cervical arthroplasty in 98 patients involved in 1 of 3 separate investigational device exemption studies from a single investigational site with a minimum 2-year follow-up…
OBJECT Cervical total disc replacement (TDR) was developed to address some of the shortcomings associated with anterior cervical… (More)
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2004
2004
Relationship of proximal fixation to postoperative renal dysfunction in patients with normal serum creatinine concentration.
OBJECTIVES This study was performed to determine whether there is deterioration in renal function during follow-up in patients… (More)
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Review
2004
Review
2004
A cardiologist in the carotids.
Carotid endarterectomy for stroke prevention has been the standard of care for 50 years in patients with extra-cranial carotid… (More)
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Highly Cited
2000
Highly Cited
2000
Lumbar interbody fusion using the Brantigan I/F cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration…
STUDY DESIGN A carbon fiber-reinforced polymer cage implant filled with autologous bone was designed to separate the mechanical… (More)
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2000
2000
Hyperspectral diagnostic imaging of the cervix: report on a new investigational device.
OBJECTIVE To describe our experience with a noncontact in vivo fluorescence imaging device for the detection and localization of… (More)
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