PAVmed files 510(k) FDA for PortIO Intraosseous Infusion System

PAVmed files 510(k) FDA for PortIO Intraosseous Infusion System

First product regulatory submission marks major corporate milestone.

January 9, 2017
Manufacturing Group
Devices/Implants/Equipment Industry/Regulations

New York, New York – PAVmed Inc., a highly differentiated, multi-product medical device company, has filed a 510(k) premarket notification submission with the U.S. Food and Drug Administration (FDA) for its first product, the PortIO Intraosseous Infusion System. 

Lishan Aklog, M.D., chairman and CEO of PAVmed, 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 commercialization in 2017 and beyond.”

PAVmed’s Chief Medical Officer, Brian J. deGuzman M.D., explained “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.”

Timothy P. Murphy, M.D., a member of PAVmed’s medical advisory board, Professor and Director of the Vascular Disease Research Center at the Brown University’s Warren Alpert Medical School and the former President of the Society of Interventional Radiology, stated “We eagerly anticipate PortIO’s regulatory clearance and introduction into clinical practice.  We expect PortIO to have significant advantages relative to traditional ports and intraosseous devices, which gives it the potential to be game-changing with respect to improved outcomes and reduced costs.”

About PortIO
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.

Source: PAVmed

FDA device cardiology