Medical device firm PAVmed is seeking approval in the US for its PortIO intraosseous infusion system.
The company has filed a 510(k) premarket notification submission with the US Food and Drug Administration (FDA) for the product, which includes an implantable vascular access device and insertion kit.
In place of a catheter in a vein, the system has a short extension from the device, which is inserted into a patient’s bone by a physician.
It lets the device to be placed completely underneath the skin and allows for direct access to bone marrow to deliver medications, fluids and other substances
The device can be inserted and removed near-percutaneously without the need for a surgical pocket or significant dissection and will also not require confirmation of the position of the tip by X-ray or other means.
Once placed, a nurse can access the device through the skin by the same techniques as existing implantable ports.
PAVmed chairman and CEO Lishan Aklog said: “We are excited to have achieved this important corporate milestone, the submission of our first product for regulatory clearance, on schedule and under budget.
“Our growth strategy is built on a capital and time efficient business model which enables us to pursue an expanding multi-product pipeline. PortIO is the first FDA submission from our pipeline and we look forward to additional regulatory submissions and product commercialisations in 2017 and beyond.”
PAVmed chief medical officer Brian deGuzman said: “PortIO was designed to eliminate many of the shortcomings of existing implantable vascular access devices and intraosseous infusion systems.
“We expect PortIO to provide physicians with a rapid and efficient system to establish an intraosseous route for delivery of medications, fluids and other substances. We look forward to receiving FDA clearance and beginning commercialization of this exciting product in 2017.”