Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

DuPont at Medtec Europe 2011: High performance polymers for use in medical devices

28.02.2011
Specific grades of DuPont engineering polymers that meet demanding requirements for use in medical equipment form the focal point of the company’s exhibit on stand 4538 at Medtec Europe 2011 in Stuttgart (22 - 24 March 2011).

The availability of these specialty health care grades broadens the choice of high performance polymers with healthcare specific manufacturing control and regulatory support. These grades are intended to support healthcare companies which lead medical progress through new and innovative devices.


Image: TiGenix
The ChondroMimetic™ from TiGenix NV is marketed as a procedure pack with the collagen implant preloaded in an accurate, easy-to-use arthroscopic delivery device. Specialty health care polymers from DuPont facilitate the smooth and accurate delivery of the implant for the user, whilst providing the material regulatory compliance for the manufacturer.

This is most recently reflected by the adoption of a Special Control (SC) grade of DuPont™ Zytel® nylon for components of an accurate and easy-to-use collagen implant delivery device. The functional performance of the DuPont material and its regulatory compliance are key factors in its specification.

The ChondroMimetic™ from TiGenix NV (Leuven, Belgium) is a CE-marked collagen based implant for the treatment of small osteochondral (cartilage and underlying bone) defects. The implant supports the body's natural repair mechanisms to encourage the simultaneous repair of both articular cartilage and the bone to which it is attached. The product, which was officially launched in Europe during the 9th World congress of International Cartilage Repair Society in October 2010, is marketed as a procedure pack with the collagen implant preloaded in an accurate, easy-to-use arthroscopic delivery device.

The device consists of several polymer components, including a white outer-casing made from ABS and a translucent polycarbonate delivery tube at its tip, which allows visual progress of the implant delivery to be maintained during the surgical procedure. Significantly, the two components made from Zytel® SC – the plunger and compressor fingers – come into direct contact with the implant and are key to holding it in place and inserting it smoothly and accurately into the defect site. The DuPont material was specifically chosen for the stiffness and low-friction behaviour of the plunger as well as providing the precise flexibility of the compressor fingers.

“We specified a Special Control grade of Zytel® nylon based on the advice that the material comes with the required level of manufacturing control, testing and regulatory support for use in our delivery device,” explains Suhaib Hassan, product manager at TiGenix. “For instance, the device is required to meet the requirements of ISO 10993, which includes testing to support the storage of the implant in contact with the plastic parts of the delivery device for its entire shelf life.”

DuPont: the material supplier of choice to the health care segment
DuPont offers one of the broadest portfolios of engineering plastics and thermoplastic elastomers for medical devices, surgical devices and for diagnostic or pharmaceutical manufacturing equipment. The DuPont health care product offering provides food agency compliance (EMSA and FDA), ISO 10993-5 and -11 compliance as well as USP Class VI compliance. Speciality health care products are manufactured following GMP.

The specialty health care grades with regulatory support are available in two versions, each reflecting different levels of manufacturing control and material testing. Customers work with DuPont to identify the version that meets the needs of their specific application. Sixteen of the products are available as “special control” grades that meet very high standards of manufacturing consistency important for a wide range of non-implantable medical products. Twelve of the grades are available in “premium control” versions meeting requirements for even more demanding manufacturing controls, broader regulatory support, more testing, DMF access and the highest level of inspection.

About TiGenix. Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a public biomedical company that focuses on ‘Regenerating Motion’. The company is exploiting the power of Regenerative Medicine to develop durable treatments, validated through controlled clinical trials, for damaged and diseased skeletal tissues. TiGenix now has two products approved for marketing and sales in Europe: ChondroCelect®, the company’s lead product for cartilage regeneration in the knee, is the first cell-based product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of characterized cultured chondrocytes derived from the patient’s own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. ChondroCelect received European Marketing Authorization as the first Advanced Therapy Medicinal Product.

ChondroMimetic™ is an off-the-shelf, collagen based implant for the treatment of small osteochondral (cartilage and underlying bone) defects. ChondroMimetic received CE-mark approval for the treatment of small chondral and subchondral lesions. It will be marketed as a procedure pack with the collagen implant preloaded in an accurate, easy to use delivery device.

The company exploits a proprietary (stem) cell and biomaterials platform, which will continue to generate candidate products that address specific musculoskeletal problems. With a fully operational sales team in place, TiGenix is ready for commercial expansion and reinforcement of its leading position in Europe in the regenerative medicine field.

The DuPont Performance Polymers business manufactures and sells Crastin® PBT and Rynite® PET thermoplastic polyester resins, Delrin® acetal resins, Hytrel® thermoplastic polyester elastomers, DuPont™ ETPV engineering thermoplastic vulcanizates, Minlon® mineral reinforced nylon resins, Neoprene polychloroprene, Tynex® filaments, Vespel® parts and shapes, Sorona® EP, Kalrez® perfluoroelastomer parts, Vamac® ethylene acrylic elastomers (AEM), Viton® fluoroelastomers, Viton® FreeFlow™ processing aids, Zytel® nylon resins, Zytel® PLUS nylon resins and Zytel® HTN high-performance polyamides. These products serve global markets in the aerospace, appliance, automotive, consumer, electrical, electronic, healthcare, industrial, sporting goods and many other diversified industries.

DuPont (www.dupont.com) is a science-based products and services company. Founded in 1802, DuPont puts science to work by creating sustainable solutions essential to a better, safer, healthier life for people everywhere. Operating in more than 90 countries and regions, DuPont offers a wide range of innovative products and services for markets including agriculture and food; building and construction; communications; and transportation.

The DuPont Oval Logo, DuPont™, The miracles of science™ and Zytel® are registered trademarks or trademarks of E.I. du Pont de Nemours and Company or its affiliates.

ChondroCelect® and ChondroMimetic™ are registered trademarks or trademarks of TiGenix NV.

Editorial Contact:
Rémi Daneyrole
Tel.: +41 (0)22 717 54 19
Fax: +41 (0)22 580 22 45
Remi.daneyrole@dupont.com

Rémi Daneyrole | DuPont
Further information:
http://www.dupont.com

More articles from Trade Fair News:

nachricht Joining metals without welding
23.04.2018 | Christian-Albrechts-Universität zu Kiel

nachricht Hannover Messe 2018: Cognitive system for predictive acoustic maintenance
19.04.2018 | Fraunhofer-Institut für Digitale Medientechnologie IDMT

All articles from Trade Fair News >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Spider silk key to new bone-fixing composite

University of Connecticut researchers have created a biodegradable composite made of silk fibers that can be used to repair broken load-bearing bones without the complications sometimes presented by other materials.

Repairing major load-bearing bones such as those in the leg can be a long and uncomfortable process.

Im Focus: Writing and deleting magnets with lasers

Study published in the journal ACS Applied Materials & Interfaces is the outcome of an international effort that included teams from Dresden and Berlin in Germany, and the US.

Scientists at the Helmholtz-Zentrum Dresden-Rossendorf (HZDR) together with colleagues from the Helmholtz-Zentrum Berlin (HZB) and the University of Virginia...

Im Focus: Gamma-ray flashes from plasma filaments

Novel highly efficient and brilliant gamma-ray source: Based on model calculations, physicists of the Max PIanck Institute for Nuclear Physics in Heidelberg propose a novel method for an efficient high-brilliance gamma-ray source. A giant collimated gamma-ray pulse is generated from the interaction of a dense ultra-relativistic electron beam with a thin solid conductor. Energetic gamma-rays are copiously produced as the electron beam splits into filaments while propagating across the conductor. The resulting gamma-ray energy and flux enable novel experiments in nuclear and fundamental physics.

The typical wavelength of light interacting with an object of the microcosm scales with the size of this object. For atoms, this ranges from visible light to...

Im Focus: Basel researchers succeed in cultivating cartilage from stem cells

Stable joint cartilage can be produced from adult stem cells originating from bone marrow. This is made possible by inducing specific molecular processes occurring during embryonic cartilage formation, as researchers from the University and University Hospital of Basel report in the scientific journal PNAS.

Certain mesenchymal stem/stromal cells from the bone marrow of adults are considered extremely promising for skeletal tissue regeneration. These adult stem...

Im Focus: Like a wedge in a hinge

Researchers lay groundwork to tailor drugs for new targets in cancer therapy

In the fight against cancer, scientists are developing new drugs to hit tumor cells at so far unused weak points. Such a “sore spot” is the protein complex...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

VideoLinks
Industry & Economy
Event News

Invitation to the upcoming "Current Topics in Bioinformatics: Big Data in Genomics and Medicine"

13.04.2018 | Event News

Unique scope of UV LED technologies and applications presented in Berlin: ICULTA-2018

12.04.2018 | Event News

IWOLIA: A conference bringing together German Industrie 4.0 and French Industrie du Futur

09.04.2018 | Event News

 
Latest News

Tiny microenvironments in the ocean hold clues to global nitrogen cycle

23.04.2018 | Earth Sciences

Joining metals without welding

23.04.2018 | Trade Fair News

Researchers illuminate the path to a new era of microelectronics

23.04.2018 | Information Technology

VideoLinks
Science & Research
Overview of more VideoLinks >>>