PRA March-April 2018 issue

Page 34

Medical Industry Biocompatible PEEK for implants Frequency of bone diseases and obesity worldwide, along with a rapidly ageing population, represent a major share in the growing implantable devices market. PEEK is among a new class of polymers that exhibits structural strength, safety, biocompatibility and commercial viability, and thus, is favoured for medical implantable devices. This segment is projected to propel the global PEEK market, which has the potential to grow at a CAGR of 6.3% from 2016-2021, across various applications, according to a report from Markets and Markets. Speciality chemicals supplier Solvay knows too well how PEEK fits the requirements in the medical sector. China-based artificial joint applications pioneer Okani Medical Technology has developed an all-polymer knee implant based on Solvay’s Zeniva PEEK. Okani’s novel ORGKnee implant is said to offer a longer service life at a lower cost than traditional metallic implant systems. The material shows suitability for femoral and tibial tray components of Okani’s knee implant, which simulates normal walking behaviour over ten years. The ORGKnee implant is also found to exhibit 50% less wear versus a metal implant, as measured by material loss over 3 million cycles. Accordingly, unlike implants made of cobalt chrome or titanium alloys, Zeniva PEEKmoulded implants exhibit a modulus similar to cortical bone, which can improve patient comfort, provide a more stable fixation over time and extend implant lifetime due to significantly reduced wear of the total knee-joint The ORGKnee implant prosthesis, says is based on Solvay’s Okani. Zeniva PEEK Additionally, PEEK’s injection moulding capability enables large-scale production of the knee implants for shorter time than it would take to make metal implants, which can take up to three months to manufacture, machine and polish using methods that can pose risks both to workers and the environment, Okani said. The implant is to undergo preclinical trials by April and standard clinic trials by China’s Food and Drug Administration (CFDA) in September. The new solution is expected to be commercialised in 2020 after obtaining approvals. Diabetes management made easier With the prevalence of so-called lifestyle diseases, such as diabetes, that are on the increase, and aided by the rising geriatric population, obesity and other risk factors, more patients welcome healthcare modalities that enable better compliance at home and at a lower cost.

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Diabetes is increasingly becoming a health scourge worldwide. The International Diabetes Federation (IDF)’s 2015 Diabetes Atlas forecast is grim. By 2040, one adult in ten or 642 million worldwide will have diabetes. Diabetes is debilitating and costly. It is projected to rack up spending of more than US$802 billion over IDF’s forecast period. Therefore, the market for global insulin delivery device is predicted to cross above US$14 billion by 2020, according to Persistence Market Research. Insulin syringes have been a preferred delivery device for self-medication of diabetes. But more convenience of use pushed for development of other technologies. Thus, alternative insulin delivery devices now come in the form of pens, pumps, implantables, wearables, and various other formats. New Jersey-headquartered Valeritas Holdings has come up with a convenient wearable device option specifically for Type-2 diabetes patients. A simple, affordable, all-in-one option that is worn like a patch and can eliminate the need for taking multiple daily shots, the V-Go wearable basal plus bolus insulin delivery V-Go's wearable device features basal plus bolus an injectioninsulin delivery device moulded features cartridge made cartridge from Topas's COC made of cyclic olefin copolymer (COC) from Topas Advanced Polymers, a business unit of engineering thermoplastics manufacturer Polyplastics. V-Go administers a continuous preset basal rate of insulin over 24 hours and provides discreet on-demand bolus dosing at mealtimes. A critical component of the V-Go’s insulin delivery device is the cartridge made of COC, which is opted over competitive thermoplastics due to its purity, drug compatibility, biocompatibility, and dimensional stability. Additionally, COC can also be moulded with zero draft and offers good injection moulding characteristics, with dimensional stability and minimal shrinkage. Unlike other engineering thermoplastics or glass, COC offers a non-ionic, minimally reactive surface. This non-polar substrate does not promote adsorption, denaturation, aggregation, or precipitation. Furthermore, the resin has low leachables and extractables, compared to glass and other medical grade polymers for drug delivery, and thus preserves long-term drug purity and enables better quality at high yields. Concurrently with the above innovations, the medical devices industry continues to advance medical and healthcare equipment to ensure efficacy of treatment and delivery of medications; and medicalgrade plastics will be at the pinnacle of this evolution.


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