US FDA clears Endophys blood pressure monitor

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Endophys has received US Food and Drug Administration (FDA) clearance on its new Blood Pressure Monitor (BPM) that allows an interface to a standard patient care monitor.

According to a press release, the company’s 6 French device will be expanded to include an 8 French device in the near future. Key features of the system include:

  • Reduced time-to-treatment: According to the company release, the pressure-sensing access system is designed to optimise patient outcomes and potential tissue salvage, as a separate arterial line no longer needs to be placed.
  • The pressure sensing access system is intended to reduce the opportunity for complications (e.g. arterial occlusions, haematoma/bleeding, artery dissection, etc.) and patient discomfort by providing accurate pressure monitoring and vascular access in one step with one device.
  • A high-precision Fabry-Perot pressure sensor and fibre optic channel is into the sheath wall. This is designed to provide accurate and continuous pressure readings 1,000 times per second down to 0.1 mmHg immediately upon insertion.