Implantable Intraosseous Vascular Access Device

The intraosseous route provides a means for infusing fluids, medications, and other substances directly into the bone marrow cavity which communicates with the central venous circulation via nutrient and emissary veins. This route, which has been used for decades, is well established and has been shown to bioequivalent to the intravenous route. PortIO is a novel, implantable, intraosseous vascular access device, which, unlike existing long-term vascular access devices, does not have a component residing in a vein. It is designed to be highly resistant to occlusion and, we believe, may not require regular flushes or radiologic confirmation. It can be inserted and removed without the need for surgical dissection and provides a limitless number of potential access sites in chronically ill patients have poor or no central venous access. We believe PortIO will have the potential to decrease costs by shifting the procedure to a less expensive office or bedside setting.

long-term vascular access devices have several limitations directly related to the presence of a catheter in a vein

Current Limitations

The core technologies underlying currently available long-term vascular access devices have several limitations directly related to the presence of a catheter in a vein. Up to 10% become infected, which can lead to costly and severe complications and even death. They require regular flushes to clear stagnant blood and prevent clot formation and occlusion. Nonetheless, up to one third become occluded at some point requiring treatment with clot-dissolving agents or removal and implantation of a new device. Most devices also require surgical insertion and removal, as well as radiologic confirmation of proper placement. In addition, many chronically ill patients have poor or no central venous access as a result of repeated instrumentation of the veins or the presence of pacemaker or defibrillator leads. A limitation of non-implantable intraosseous devices is that the device exits the skin and can be difficult to protect and susceptible to dislodgement.

Market Opportunity

Long-term vascular access devices, including implanted ports, are used to deliver various fluids, medications, and other substances to patients with a wide variety of clinical conditions over a period of weeks to months. Short-term, non-implantable intraosseous devices, which are inserted into the bone marrow instead of a vein, are commonly used in military trauma, pediatric emergencies, and other situations where rapid vascular access is required. The annual addressable markets for implantable vascular access ports and non-implantable intraosseous devices are estimated to be $500 million and $150 million respectively.

 

*PAVmed has not yet received clearance from the FDA or any other regulatory agency for PortIO.