The NanoGraft: A superiority substitute over the commercial vascular grafts

Background Information

Globally, millions of patients are affected by heart attack or limb gangrene/amputation due to blockage of small diameter (< 5 mm) blood vessels. After more than half a century of research, the available surgical treatment to bypass the blocked vessel is based on synthetic vascular grafts that provide only sub-optimal benefits. More than 50% of the synthetic grafts fail at one year due to poor healing, leading to excessive inflammation and blood clot. Another reason attributed to the failure is the mismatch in mechanical properties of the commercial graft with the native blood vessel. Hence, there is a critical clinical unmet need for more effective small-diameter arterial conduits that promotes healing and rapid tissue regeneration integrated with the native blood vessel.

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Research

o address the limitations, our team developed a highly flexible vascular graft to substitute blood vessels from woven nanotextiles, named NanoGraft. The nanothreads were developed into a tubularconstruct by a custom-designed robotic device detailed in the US patent US20190110883A1. Extensive mechanical and in vitro lab testing were performed to confirm that our graft meets the ISO requirements of the vascular prosthesis. Detailed large animal studies in pigs confirmed the superior properties of nanotextile vascular graft over the commercial standards. The novel material showed minimal foreign body inflammatory reaction with no sign of blood clots, along with rapid healing and host tissue integration. All the nanotextile-based graft implanted in the pig model showed uninterrupted blood flow compared to 66% block in the commercial grafts at one month.

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Application

The advent of nanotechnology in medical textiles surpassed the limitations of current synthetic graft. Superior strength, flexibility, and accelerated healing response favor the translation of the material to a commercial product. Therefore, a pivotal long-term preclinical study is warranted as a final step of validation toward a first-in-human pilot trial. This could potentially address the need of tens of thousands of patients that require the bypass surgery

Applictions

Publications

Joseph J, Krishnan AG, Cherian AM, Rajagopalan B, Jose R, Varma P, et al. Transforming Nanofibers into Woven Nanotextiles for Vascular Application. ACS Appl Mater Interfaces 2018. Jun13;10(23):19449-19458

Sulaiman NS, Bond AR, Bruno VD, Joseph J, Johnson JL, Suleiman M-S, et al. Effective decellularisation of human saphenous veins for biocompatible arterial tissue engineering applications: Bench optimisation and feasibility in vivo testing. J Tissue Eng. 2021 Jan 1;12:2041731420987529.

Patents

Menon D,Joseph J, Varma P, Nair SV. Strong, flexible and thrombus free, small diametervascular graft fabricated from electrospun polymeric nanoyarns, and process thereof.US20190110883