PAVmed Inc., a multi-product medical device company, has set a Q4 2016 timeline for FDA 510(k) submission of its first product, the PortIO implantable vascular access device. PortIO has entered verification and validation testing, the final phase of pre-submission testing.
“We are excited about our timeline for submitting PortIO to the FDA in 2016 and the prospects for product commercialization in 2017,” said Lishan Aklog, M.D., Chairman and CEO of PAVmed. “Since obtaining our IPO funding in April, we have accelerated the pace of advancing the products in our pipeline towards FDA submission and commercialization. Our capital and time efficient business model enables PAVmed to pursue a multi-product pipeline strategy and PortIO will be the first FDA submission from this pipeline.”
“PortIO was designed to eliminate many of the shortcomings of existing implantable vascular access devices, which result from the presence of a catheter in the bloodstream,” said PAVmed’s Chief Medical Officer, Brian J. deGuzman M.D.
PortIO 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.
Since it is about one-third the size of a traditional implantable vascular access device, PortIO can be inserted and removed near-percutaneously without requiring a surgical pocket or other dissection. In addition, unlike existing devices, PortIO 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 devices.