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This early result in a small sample is significantly quicker in recovery and improvement when compared to the historical control of the LT cage with Infuse IDE study.
The CHARITÉ artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study.
This phase I IDE study (STAPLE-1) evaluated the primary endpoints of safety (major device-related adverse events at 30 days) and feasibility (successful deployment of all endograft components) of the Aptus Endovascular abdominal aortic aneurysm (AAA) Repair System (Aptus Endosystems, Inc, Sunnyvale, Calif) to treat AAAs.
J.T.H. is an employee of Medtronic Inc. D.B.M. is a paid proctor and consultant for Medtronic Inc. and was an investigator in the Medtronic Melody TPV U.S. IDE study.
No financial support was received directly in support of this study, although some of the data was collected as part of an IDE study funded by Wright Medical Technologies.
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This series was a phase-I, IDE managed study to evaluate safety of the NeuroBlate System in 10 patients with recurrent GBM.
The in vitro activity of IDE was studied using either partially purified cytosolic enzyme from male Sprague-Dawley rats, or purified rat recombinant enzyme.
Ide, C. Histochemical study of lamellar cell development of meissner corpuscles.
Extending from the suggested framework of Ide (2014), this study employs numerical simulations to demonstrate how the occurrence of small events (i.e., the behavior of small patches) changes due to the surrounding large patch or background behavior.
In contrast, in a large Japanese study Ide et al [ 12] found a strong correlation between the number of missing teeth and higher OHIP scores suggesting impairment of OHRQoL.
In a recently published study, Ide et al. showed that the reproducibility of evaluation methods for dentin hypersensitivity is difficult to achieve, even when standardized techniques were used [ 35].
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