Improved Medical Polymer Offers Improved Strength and Innovative Surface Technology for Chronic Implants
DSM PTG, part of DSM Biomedical, a global leader in biomedical materials science, today announced the availability of Bionate® II PCU, a versatile medical polymer with built-in surface technology designed for chronic implants.
Bionate® II PCU is a line extension of the well known Bionate® Polycarbonate Urethane family, one of the industry’s leading medical polymers for long-term implants and is backed by an established FDA Master File. The new polymer offers improved performance and processing characteristics for medical devices. It includes patented SAME® technology, a built-in surface modification utilizing surface activity and self assembly of chemical groups attached to the ends of each polymer molecule during synthesis. This breakthrough technology enables medical devices to be equipped with permanent surface modification while maintaining excellent mechanical properties. It can also eliminate the need for secondary surface treatments once a device is made.
Cincinnati-based PMC Medical, a contract manufacturer delivering solutions in complex polymer molding and assembly, evaluated the processability of Bionate® PCU versus Bionate® II PCU. "Upon the conclusion of our experiments, we determined that DSM PTG's Bionate® II PCU is more easily processed for injection molding applications," said Bob Langlois, Executive Director of Applied Technology.
In addition to providing controlled surface chemistry and better processing, Bionate® II PCU also offers improved oxidative stability and greater strength than the first generation Bionate® PCU.
“We believe Bionate® II PCU with SAME® technology offers a performance breakthrough in high-strength, biostable polymers for medical device designers. It is the next step in the continuous improvement of our biomedical thermoplastics, offering customizable surface chemistry for unique medical device designs,” said Bob Ward, President and CEO of DSM PTG. “In the case of Bionate® II PCU, we have made minor changes to a proven polymer family that improve the polymer’s processability and oxidative resistance, and significantly increase its strength.”
The Bionate® PCU family has been extensively tested and is used in many commercially-available long term implants, including pacemaker leads, ventricular assist devices, catheters, stents, spinal discs, neurostimulation devices, hip and knee joints, and spinal fixation systems.
About DSM Biomedical
DSM Biomedical develops novel materials-based solutions to meet the present and future needs of the medical device and biopharmaceutical industries. Building on the expertise and strengths of DSM and its acquisition of The Polymer Technology Group, which is now known as DSM PTG, the company’s product portfolio includes coatings, drug delivery platforms and a wide range of biomedical materials for use in short- and long-term implantable medical devices. Key product brands include Bionate® PCU and CarboSil® TSPCU, two of the most extensively tested biomedical polymers ever developed. Both polymers have excellent biostability, high strength and abrasion resistance, making them candidate materials for load-bearing orthopedic implants. ComfortCoat™ hydrophilic and antimicrobial coating technology for catheters, guidewires and stent delivery systems; and Dyneema Purity®, a high-performance polyethylene fiber technology developed specifically for use in medical applications, such as orthopedic implants. The company also markets the Trancerta™ family of bioresorbable materials for drug delivery. This portfolio is based on DSM’s core strengths in materials science combined with its extensive in-house library of synthesis methods, formulation and processing techniques. For more information, visit www.dsmbiomedical.com.
DSM – the Life Sciences and Materials Sciences Company
Royal DSM N.V. creates innovative products and services in Life Sciences and Materials Sciences that contribute to the quality of life. DSM’s products and services are used globally in a wide range of markets and applications, supporting a healthier, more sustainable and more enjoyable way of life. End markets include human and animal nutrition and health, personal care, pharmaceuticals, automotive, coatings and paint, electrical and electronics, life protection and housing. DSM has annual net sales of EUR 9.3 billion and employs some 23,500 people worldwide. The company is headquartered in the Netherlands, with locations on five continents. DSM is listed on Euronext Amsterdam. More information: www.dsm.com.