Over the years, a variety of embolizing agents have been used, from gelatin foam to polyvinyl alcohol (PVA) particles and recently— drug eluting beads. Polyvinyl alcohol particles were first introduced as an intravascular embolization agent in 1974 in the form of a sponge. Gelatin foam has been used as an intravascular embolization agent for more than 30 years, with the first intravascular used for cavernous carotid fistulas.
Embolization is a minimally invasive therapy to stop bleeding as well as to stop blood flow to a tumor in order to shrink it or in preparation for removal. Embolization is an option for some patients with tumors that cannot be removed by surgery.
Cancer is one of the major group of diseases of our time as it leads to rising morbidity and mortality, and also diminishes the quality of life of a large number of affected individuals to a great extent. For instance, hepatocellular carcinoma (HCC) is the 6th most common cancer worldwide with over 500,000 new cases diagnosed every year. Embolization particle are used in the treatment of various types of cancer such as liver cancer, brain cancer, lung cancer.
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The market for embolization particle is expected to reach around USD 1,909.76 million by 2023 from USD 899.41 million in 2016.
Currently embolic particles, such as calibrated microspheres and polydisperse particles are being used. On the other hand, microsphere technology is an important advancement in narrowing embolization particle size distribution. Microspheres have several advantages over polyvinyl alcohol particles and gelatin sponge.
Company like Terumo in 2015, invested in Quirem Medical, to focus and develop the interventional oncology segment. Lifepearl and Hydropearl are drug-eluting microsphere products used for chemoembolization.
On the other hand, drug eluting particles is the next phase in the evolution of embolization particles. Drug-eluting beads is a novel system which consists of embolic microspheres preloaded with doxorubicin that controls the release of chemotherapeutic agents.However, drug-eluting bead transarterial chemoembolization therapy is used for the treatment of hypervascuarized tumors. Through the intra-arterial delivery of microspheres, drug-eluting bead transarterial chemoembolization allows embolization as well as local release of chemotherapeutic agents in the treatment of hepatic malignancy, which is an alternative therapeutic option for unresectable tumours.
Cook Medical, in 2012, launched the first drug-eluting stent called Zilver PTX in Australia to treat peripheral arterial disease and which now is available in 50 countries. According to the company’s reports “Many physicians now are convinced, drug elution is the future of treating lesions in the leg arteries, and Australian Zilver PTX launch is an important step in Cook’s efforts to bring this advanced treatment to patients and physicians worldwide.”
On the other hand, in February 2017 BTG and the Society of Interventional Oncology established a working group to explore the role of minimally invasive therapies in immuno-oncology which included interventional radiologists and immuno-oncologists. This working group will identify unmet clinical needs and the critical areas of science that require further dedicated research. The working group plans to publish a white paper to guide research and clinical practice later this year.
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Microfluidics affords numerous advantages in designing embolization particle over conventional techniques. Microfluidic are cost-effective, and require minimal training to operate. Moreover, every particle produced in microfluidics is the same size, no size filtering of the generated particles is required which is much advantageous than standard microsphere synthesis methods, in which size specificity should be attained by removing large particles through a series of filters.
Tissue engineering, is another method like microfluidics which will enhance the effects and potency of particle embolization materials. Materials used for particle embolization can be redesigned with tissue engineering to improve its functionality.
In some developed countries like the United States, strict regulatory rules have been notified to the manufacturers in order to prevent hazardous drugs from entering the market.
The preparation of embolizing drugs fall under the FDA and CDSA, which is responsible for the drugs to stick to strict compliances of safety and hygiene. The approval scenario for these particles cross over to the manufacturing side as well and it is imperative for the manufacturers to adhere to the stipulated guidelines. Failure to do so, restricts a potential drug’s entry into the market. Embolization particle are not new to these stringent regulations which pose as a direct roadblock for the market.
Adding to the limitations further, lack of interventional neuroradiology labs coupled with lower professional expertise in neuroradiology is another factor hampering the embolization particles to be available to the target consumer base. Interventional radiology is a rapidly growing area of medicine. Interventional radiologists are specially trained doctors who infer x-rays, ultrasound, and other medical images to guide small instruments through blood vessels and other pathways to treat disease without an open surgical incision. Mostly all procedures performed by interventional radiologists are minimally invasive i.e. they do not require an open surgical incision.
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The ever developing field of healthcare will witness an exponential uptake of innovative trends out of sheer convenience to impart a better patient satisfaction and effective remediation. On this pretext, embolization particles are developing a niche in Medicine and Surgery which will pave way for a better future for the same.
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