Arjun Luthra, commercial director of BioInteractions, shares how Surface Active Therapeutics represent a leap in safeguarding medical devices.
BioInteractions
In the ever-evolving landscape of healthcare, the need for advanced protective measures for medical devices has never been more critical. Surface Active Therapeutics represent a groundbreaking leap in safeguarding these devices, ensuring they remain free from infections and complications throughout their lifespan. As healthcare-associated infections (HCAIs) continue to pose significant challenges, innovative solutions like those developed by BioInteractions are pivotal. By integrating cutting-edge antimicrobial and antithrombogenic coatings, BioInteractions is leading the charge in enhancing patient safety, improving implant efficacy, and delivering superior therapeutic outcomes.
Surface Active Therapeutics are advanced active treatments which do not need to release their ingredients that are applied directly to the surface of a medical device to help reduce the impact of clinical issues such as thrombosis, Fibrin Sheath Formation or infection. They provide highly effective and sustained protection therapeutic benefits to the patient. They use enhanced materials that form a continuous protective shield over the surface. This shield is made of a polymer matrix, which combines active and passive components to improve the biocompatibility of the implant, enhance the efficacy of the device and elevates the therapeutic benefits to the patient.
Recent advancements in Surface Active Therapeutics involve applying effective localised therapeutics to various substrates and geometries, including catheters, drainage systems, ventricular devices, heart valves, and neurological stents. Advanced antimicrobial coatings like BioInteractions’ TridAnt create a continuous protective shield that combines active and passive components to protect against pathogens comprehensively. This matrix ensures a rapid contact-kill mechanism, broad-spectrum efficacy, continuous residual protection, and the ability to disrupt and prevent biofilm growth, effectively combating a wide range of infections for the patient's entire lifetime.
These coatings offer the best protection, killing a broad spectrum of pathogens, including bacteria, viruses, fungi, and spores. These include E. coli, MRSA, Influenza, Adenovirus, Norovirus, Clostridium difficile, and SARS-CoV-2. The technology is effective on various geometries and substrates, from soft materials like silicone and fabrics to hard materials like metals (stainless steel and nitinol) and polymers (polyamides, polycarbonates, and polyurethanes).
TridAnt is a unique Surface Active Therapeutic that provides a localised effect, making it safe for use throughout the body. It is designed for lifetime efficacy on class 3 implants in chronic areas of the human body. Its polymeric matrix is biocompatible, targeting only microbes (prokaryotic cells) and remaining effective at the local surface to provide sustained efficacy for the patient. This targeted approach enhances safety by avoiding the systemic effects seen with other eluting coatings, which also reduce in efficacy over time. Consequently, TridAnt-coated medical devices maintain a highly effective, fast, durable, and localised protective shield against a broad spectrum of pathogens which disrupts and prevents biofilm throughout the device's lifetime.
BioInteractions: Pioneering innovation
BioInteractions is at the forefront of innovation in the development of biocompatible coatings for medical devices. Recent surgically implanted devices often require removal, re-insertion, or extensive drug regimens for the patient's lifetime. This has driven the need for coatings that meet both clinical and engineering requirements. Devices like total artificial hearts (TAHs), ventricular assist devices (VADs), vascular stents, and prosthetic mechanical heart valves assist vital organs but face the common challenge of lifetime hemocompatibility, specifically thrombosis.
Surface Active Therapeutic technologies offer superior biocompatibility, lifetime antithrombogenicity, and significantly reduce the risk of fibrin sheath formation. BioInteractions developed Astute, an advanced antithrombogenic coating used on chronic, blood-contacting medical implants for over 25 years. Astute combines active and passive components to provide the highest performance and most durable antithrombogenic coating on the market. The active component prevents platelet activation and halts the blood cascade mechanism to inhibit thrombus formation, while the passive components prevent blood components from depositing on the device surface. This multi-faceted approach ensures superior hemocompatibility without compromising performance of the device whilst reducing the risk of clotting over the patient's lifetime.
Additionally, the development of miniaturised and minimally invasive procedures presents challenges such as reducing tissue trauma through decreased friction during device insertion and removal. BioInteractions has addressed this challenge by developing Assist, a hydrophilic coating that reduces friction. It is uniquely flexible and durable which enables it to be applied to a wide range of medical devices. Assist fills in surface microstructures, improving the flow of liquids and reducing bodily component deposition and adhesion. This ensures devices remain functional and safe while implanted. Assist is instantly activated through wetting, eliminating the need for pre-soaking and saving preparation time, allowing for straightforward device deployment.
Through these innovations, BioInteractions continues to lead the way in enhancing the safety and efficacy of medical devices, improving surgical outcomes, and providing better therapeutic results for patients.
Current issues faced by medical product developers
Medical product developers and manufacturers navigate a highly regulated environment. Under current European Union (EU) regulations, medical devices are tested by the European Medicines Agency (EMA) following a similar approval processes as pharmaceuticals. BioInteractions' Product Pathway Partnership team works closely with customers to navigate all aspects, including optimising the application process, fixture design, tooling, coating performance testing, regulatory compliance, and providing coating services. This partnership aims to help customers get to market efficiently and effectively with the highest quality coated device.
The expanded Product Pathway Partnership alongside BioInteractions' integrated service streamline the research and development of new innovative coating materials. With 30 years of expertise and novel analytical resources, BioInteractions creates optimal coatings for various devices. This service further leverages BioInteractions' experience and technology portfolio to develop bespoke coatings for unique clinical unmet needs that have never been seen before, providing revolutionary and state-of-the-art solutions for their partners.
The future of Surface Active Therapeutics
Surface Active Therapeutics promises to revolutionise medical device technology, making implants safer, improving medical implant performance, and enhancing patient safety. Advanced antimicrobial and antithrombogenic coatings, such as TridAnt and Astute, will play a pivotal role. The TridAnt coating provides quick and sustained, broad-spectrum protection against pathogens, ensuring enhanced cleanliness and reducing post-surgical infections, leading to quicker recoveries and fewer complications.
Astute combines active and passive antithrombogenic protection which prevents platelet activation and fibrin sheath formation, addressing significant risks associated with blood-contacting implants. This innovation will ensure lifetime antithrombogenicity, enhancing the safety and functionality of devices like heart valves and stents, minimising the need for additional surgeries and long-term medication.
Personalised, biocompatible coatings tailored to individual patient needs will further improve outcomes by ensuring optimal performance and minimal adverse reactions. Patients will benefit from improved implant longevity, better therapeutic results, and enhanced quality of life.