A U.S. government health-care agency is seeking manufacturer studies on intravascular diagnostic and imaging medical devices that can help federal officials’ effectiveness reviews of that equipment.
On Dec. 14, 2011, the Agency for Healthcare Research and Quality (AHRQ) posted a Federal Register notice—Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices—requesting “scientific information submissions from manufacturers of intravascular diagnostic and imaging medical devices.” The medical imaging areas AHRQ wants data on are:
- Coronary Flow Reserve (CFR)
- Fractional Flow Reserve (FFR)
- Intravascular Magnetic Resonance Imaging (MRI)
- Intravascular Ultrasound (IVUS)
- Intravascular Ultrasound (VH-IVUS) with Virtual Histology
- Optical Coherent Tomography (OCT)
- Near- Infrared Spectroscopy (NIR)
AHRQ says the scientific information being solicited is to inform the agency’s “Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging Techniques versus Angiography Alone, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program.”
The agency is “looking for studies that report on intravascular diagnostic and imaging medical devices, including those that describe adverse events,” the notice says. Access to published and unpublished scientific information provided by stakeholders on those devices and systems “will improve the quality of this comparative effectiveness review,” AHRQ says. The deadline to submit such research is Jan. 13, 2012.