PAVmed Seeks US FDA Nod for PortIO Intraosseous Infusion System.
M2 PHARMA-December 21, 2016-PAVmed Seeks US FDA Nod for PortIO Intraosseous Infusion System
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- US-based medical device company PAVmed Inc. (NASDAQ: PAVM) has filed a 510(k) premarket notification submission with the US Food and Drug Administration for its first product, the PortIO Intraosseous Infusion System, the company said.
The PortIO Intraosseous Infusion System consists of an implantable vascular access device and insertion kit.
Instead of a catheter located in a vein, it has a short extension from the device, which a physician inserts into a bone, leaving the device to reside completely beneath the skin.
This allows direct access to the bone marrow, which is a well-established route for the delivery of medications, fluids and other substances.
PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or significant dissection and will not require confirmation of the position of the tip by x-ray or other means.
Once in place, the device can be accessed by the nurse through the skin using the same techniques as existing implantable ports.
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|Date:||Dec 21, 2016|
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