The Need
Airway obstruction is one of the more common complications during monitored anesthesia care (MAC), largely because patients are sedated but not fully intubated. Estimates vary depending on the population, procedure, and depth of sedation, but broadly:
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Mild to moderate airway obstruction (e.g., partial collapse, snoring, need for repositioning) can occur in roughly 10–30% of MAC cases.
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Interventions such as jaw thrust, chin lift, or airway adjunct placement are needed in a similar range, often overlapping with the above.
Risk increases with:
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Deeper sedation (especially with agents like propofol or opioids)
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Obesity and Obstructive Sleep Apnea
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Older age
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Supine positioning
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Procedures involving the head/neck or airway
Because of this, MAC always includes the need for continuous monitoring and readiness to intervene quickly, which is where the SAM device can help.
How SAM Helps
Stable Positioning
Maintains sniffing position throughout the procedure, reducing the need for adjustment or manual intervention.
Procedural Efficiency
Supports streamlined workflow in high-volume procedural environments.
MRI Compatibility
Non-metallic construction enables use in MRI and other imaging modalities.
Disposable Design
Single-use construction eliminates sterilization requirements and simplifies supply chain management.
Cost Conscious Implementation
Low-cost design to support operational efficiency while maintaining patient safety standards.
Regulatory Standing
• FDA Class I medical device
• Non-Significant Risk (NSR) designation
• Investigational Device Exemption (IDE) in place
• Patent protected (U.S. Patents 11,523,961 and 11,806,285)
Quality Manufacturing
Manufactured, assembled, and packaged at Klann Plastics in Waynesboro, Virginia using medical-grade materials.
Klann Plastics is a ISO 9001:2015 certified manufacturer, UL recognized molder, and a contract manufacturer of medical devices that are FDA listed.
