Medical device thrombosis costs the U.S. healthcare system an estimated $1 billion annually with over 50,000 deaths per year caused by thromboembolism. The current standard of care is either uncoated products or products coated with heparin or lubricious materials. The challenge with coatings for devices is that they are difficult to present on both the inner and outer surfaces of the device, have limited long term effectiveness due to lack of bio-durability, and are prone to stripping in vivo or during chemical and physical preparation of the device prior to its use. Coatings also add costs to the manufacturing process and heparin coatings in particular can result in many serious side effects.
IBI's Endexo™ technology for blood contacting medical devices, addresses such thrombosis problems. Endexo anti-thrombogenic additives, (not coatings) are low molecular weight fluoro-oligomers that impart a passive surface to the implantable medical device thereby reducing platelet adhesion and thrombus formation.
The video below illustrates the simple process of using the Endexo™ technology. The Endexo™ SMMs (surface modifying molecules) are added to the base polymer and compounded prior to the normal manufacturing process. The Endexo SMMs then migrate or self-locate to the air/device interface: intraluminal, extraluminal and cut surfaces. This passive surface leads to a reduction of platelet adhesion and activation, protein adsorption and thrombus formation (average reduction 75%+ reduction versus control group). Endexo™ technology is compatible with a wide range of base polymers, has passed ISO 10993 bio-compatibility tests, has long-term effectiveness, and has minimal or no impact on device functionality and manufacturing processes. The AngioDynamics BioFlo PICC with Endexo™ technology was recently cleared by the FDA for commercial sale in the US.
Two specific applications where Endexo™ additives have demonstrated advantages include:
Vascular Access Devices which represent more than a billion dollar global market opportunity. Thrombosis leads to catheter dysfunction which can lead to inadequate blood flow, an inability to aspirate or infuse and potential for thromboemboli.
Products containing Endexo demonstrated a 75% + reduction in thrombus versus control; conducted in a test environment
Hollow Fiber Membranes (e.g. hemodialyzers and hemoconcentrators), which represent greater than a two billion dollar global market opportunity. Thrombosis within fibers and dialysis units leads to filter failure and reduced filtration efficiency. The current use of heparin solutions can result in many side effects for dialysis patients and there is a clinical desire to reduce the amount of heparin used.
Endexo™ dialyzers demonstrated reduced thrombus versus commercial control.
Interface Biologics utilizes an efficient OEM licensing model for this technology and currently has two OEM licensing agreements:
Fresenius Medical Care
(for chronic dialysis systems)
(FDA 510(k) clearance for BioFlo PICC)