TekniPlex Healthcare showcases offering of catheter design services
2024-03-26
TekniPlex Healthcare will highlight its recently added catheter design and manufacturing capabilities at the China International Medical Equipment Fair (CMEF), 11-14th April in Shanghai.
At Hall 8.1, Stand W41, the company also will showcase its PTA/PTCA Balloon Catheter Tubing for coronary and non-coronary angioplasty applications, which are produced and extruded in ISO-certified cleanrooms and can incorporate up to three layers of specified raw materials.
TekniPlex Healthcare now offers additional product service solutions to support its customers from early ideation stage through product development and full production of catheter-based systems. This includes product design, prototyping, an array of precision secondary processes, and clean room assembly of Class II and Class II devices, including the design, development and fabrication of stents and stent delivery systems.
At CMEF, TekniPlex Healthcare will highlight its offerings as an end-to-end service provider of interventional device solutions by featuring its PTA/PTCA Balloon Catheter Tubing for coronary and non-coronary angioplasty applications. Ranging in balloon size from 1 to 30mm, the company’s customised balloon catheter tubing is manufactured at tight tolerances (± .0005”) with concentricity of over 90%. The tubing’s controlled elongation rate provides blown balloons with uniform wall thickness, improving overall yield and substantially reducing bursting risk.
TekniPlex Healthcare’s tri-layer inner tubing constructs are particularly sophisticated. The solutions consist of polyamide (nylon) or polyether block amide copolymer (PEBA) outer layers with high-density polyethylene (HDPE) inner layers. The small-diameter, thin-wall, tight-tolerance, high-precision configurations are required for use in interventional vascular apparatuses to allow diagnostic and therapeutic devices – for example, balloon catheters for coronary, peripheral and neurovascular intervention – to more easily advance over guidewires.
The inner tubing’s HDPE inner layer reduces friction on the wire, while the outer layer is bondable to balloon catheter tubing of similar materials; the middle layer is an extremely thin adhesive ‘tie layer’. The thickness of the inner and outer layers can be customised to suit various applications.
TekniPlex Healthcare will also showcase its paratubing, which the company can produce in up to eight customer coloured, textured, or striped tube formations to distinguish between flow paths. Other examples include patented multilayer tubing configurations that offer extremely low absorption properties to help extend the usable life of insulin and other unstable drug products, such as chemotherapy drugs. Another patented configuration, designed for fluid transfer of DMSO and other solvent suspensions, allows for safe product delivery in dual hormone delivery systems and advanced cell & gene therapy processes.
“In the past few months, TekniPlex Healthcare has become a fully functioning contract development and manufacturing organisation, capable of partnering with medical and healthcare customers right from the concept stages and straight through to large-scale production,” said Chris Qualters, CEO for TekniPlex Healthcare. “In terms of balloon catheter tubing specifically, our precise manufacturing techniques can incorporate up to three layers of specified raw materials, and are extruded in ISO-certified cleanrooms. This prowess is only bolstered by participating in the initial product design and development phases.”
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