A life with implants and how we evolve together

On the cover of Med-Tech Innovation Magazine, Arjun Luthra, BioInteractions’ Commercial Director, discusses how the company’s surface active therapeutics are being used for the prevention and protection of medical devices against infections.

Using Surface Active Therapeutics for the prevention and protection of medical devices against infections is becoming more and more important, as the number of healthcare associated infections (HCAIs) rises. While researchers have been able to pinpoint some causes of HCAIs, there is still a need to protect complex surfaces, like implants, from device-related infections, and surgical equipment to be protected from germs and microbes. Safeguarding all surfaces in healthcare is critical to evolving the infection prevention infrastructure for patients, professionals, providers and visitors. The demand for implantable devices to be included within the evolving infection prevention infrastructure keeps increasing, as using medical implants protected with a highly effective localised antimicrobial coating improves the safety to patients by reducing device related and surgical site infections, enhances the longevity of the implanted device which leads to superior therapeutic results for patients and increasing health-outcomes.

New developments in an advanced category of coatings—Surface Active Therapeutics (the application of highly effective and localised residual therapeutics on to a wide range of substrates and geometries such as catheters, drainage systems, ventricular devices, heart valves and neurological stents) — are the state-of-the-art solutions for all medical devices today. Enhanced antimicrobial coatings, such as TridAnt®, create a continuously protective shield over the surface, comprised of a polymeric matrix which combines active and passive components to provide complete protection against pathogens. The polymeric matrix ensures the fastest contact-kill mechanism, the broadest spectrum efficacy and continuous residual protection. In addition, it has the ability to disrupt and prevent biofilms, therefore offering a new way to combat a wider range of infections more effectively, efficiently and for the entire lifetime of a patient.

Overall, these coatings are proven to provide monoclonal protection, which kills the broadest spectrum of pathogens, including gram-positive and gramnegative bacteria, as well as enveloped and non-enveloped viruses, fungi and spores such as E.coli, MRSA, Influenza, Norovirus, Clostridium difficile and SARS-Cov-2, for the lifetime of a patient. TridAnt® continues to provide superior benefits for devices and has been shown to disrupt as well as prevent biofilm for the lifetime of the device.  The technology provides protection against pathogens on a wide range of geometries and substrates ranging from soft materials such as silicone as well as woven and non-woven fabrics all the way to hard materials such as metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates, and polyurethanes).

TridAnt® is a unique Surface Active Therapeutic which provides a localised effect and therefore is completely safe to use in all environments within the body. It has been tailored specifically for life-time class 3 implants, which are implanted inside chronic areas of the human body. Its unique polymeric matrix is biocompatible and only targets microbes (prokaryotic cells). In addition, it is only effective at the surface which provides enhanced safety from the multi-action coating, unlike other eluting coatings. As a result, TridAnt®-coated medical devices are protected consistently with a highly effective, fast, durable, safe, localised shield that disrupts and prevents biofilm for the entire lifetime of the device.

What do future medical device innovations and trends look like?

There have been impressive products released over the last few years in the areas of surgically implanted devices, but many of them have to be removed and re-inserted or they are accompanied with extensive drug regimens for the entire lifetime of a patient. This has prompted developers to introduce biocompatible coatings that can meet not only the clinical but also the engineering requirements for these devices. Devices such as total artificial hearts (TAHs), ventricular assist devices (VADs), vascular stents, and prosthetic mechanical heart valves are examples of technologies used to assist vital organs in functioning normally. However, they share a common constraint: lifetime hemocompatibility, specifically thrombosis.

Surface Active Therapeutic technologies are a stateof-the-art way of providing superior biocompatibility, lifetime antithrombogenicity and significantly reducing the risk of stenosis. BioInteractions have developed Astute®, an advanced antithrombogenic coating which has been used successfully on chronic, blood-contacting medical implants for over 25 years. Astute® is a Surface Active Therapeutic that combines an active component with additional passive components to mimic the natural endothelial layer.

The active component gives the coating the ability to interrupt the blood cascade mechanism, preventing platelets from activating and hinders thrombus formation. The additional passive components prevent blood components from depositing on to the device surface. This multi-faceted approach provides superior hemocompatibility to the surface without any reduction in performance for the lifetime of the patient.

In addition, the burgeoning development of miniaturised and minimally invasive procedures includes a variety of challenges like decreasing the amount of tissue trauma by way of reducing friction during the insertion and removal of the devices. This can lead to improved surgical outcomes, less pain and more comfort during recovery.

At BioInteractions, we have sought to meet this challenge by developing a Hydrophilic Coating called Assist™, which is lubricious, flexible and significantly reduces friction. It has been applied to a wide range of medical devices, such as joints without particulate formation and delamination in high-stress and high-movement applications. Assist™ also fills in the microstructures of the surfaces which improves the laminar flow of liquids. This significantly reduces the deposition and adhesion of bodily components on the surface, enabling the devices to remain functional and safe whilst being implanted within the patient. Assist™ is instantly activated through wetting, eliminating the need for pre-soaking the surface. This not only saves preparation time for the devices but also allows for a straight-forward deployment of the device.

What are the major issues customers are dealing with today?

Universally, medical product developers and manufacturers navigate a highly regulated and particularly constrained environment. Under today’s European Union (EU) regulations, medical devices are considered medicines and are therefore tested by the European Medicines Agency (EMA) following the same tests and approval processes that drugs do. Our Product Pathway Partnership team closely work with customers to navigate all areas including optimisation of the application

process, fixture design and tooling, biocompatibility testing, regulatory compliance and providing coating services as an organisation’s commercial manufacturing partner. We provide guidance along a strategic pathway with a focus on offering a flexible approach to meeting all of the ever-revolving regulatory demands on a wide variety of devices coated with our technology. The aim of our Product Pathway Partnership is to enable customers to get to market in the most efficient and effective way possible.

Alongside the expanded Product Pathway Partnership, our integrated service streamlines the research and development of new innovative coating materials using its 30 years of expertise and a range of novel analytical resources to create the optimal coating for your device. BioInteractions’ experience and broad technology portfolio allows us to create bespoke coatings for a wide range of applications building on the innovative solutions provided today. This unique aspect of the service draws on our expertise and knowledge in applying innovative solutions to a wide variety of devices and enables us to provide revolutionary and state-of-the-art solutions for our partners.