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Access for Life subcutaneous sensor-equipped device features: 
  1. Two sensor-equipped implantable medical devices are positioned subcutaneously, one proximal and one distal to the arteriovenous fistula or graft.

  2. The device facilitates percutaneous access by providing real-time visual or haptic guidance for needle insertion at a predetermined optimal puncture site. This minimizes the risk of vascular wall injury and extravasation (infiltration) by ensuring accurate needle placement and minimizing the number of needle passes.

  3. The device is designed to potentially mitigate the development of several access-related complications, including pseudoaneurysms, hematomas, thromboses, and stenosis, while also reducing the risk of nosocomial infection.

  4. The integrated sensors potentially enable real-time monitoring of needle depth during cannulation, thereby minimizing the risk of inadvertent perforation of the posterior vascular wall.

  5. The incorporated sensors provide real-time feedback regarding needle dislodgement, potentially serving as an early warning system to prevent a "never event."

  6. The real-time dislodgement alert provided by the device may promote the adoption of nocturnal hemodialysis. This treatment modality offers potential advantages for patients, including improved sleep quality, cardiovascular stability, and enhanced removal of uremic toxins.

  7. The device facilitates continuous data collection through integrated sensors. This real-world data has the potential to be utilized in developing and refining personalized predictive algorithms for optimizing treatment regimens. Additionally, anonymized and aggregated data analysis ("Big Data") could yield valuable insights for improving vascular access procedures and patient outcomes across broader populations.

Clinical Application Areas for Adults and Pediatrics
  • Hemodialysis

  • Chemotherapy

  • Blood disorders

  • Digestive disorders

  • Chronic disease patients in need of repetitive vascular access

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