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 OLEDs applied to paper-thin stainless steel
21.09.2017 | Fraunhofer-Institut für Organische Elektronik, Elektronenstrahl- und Plasmatechnik FEP

nachricht New VDI standards established for cleanroom technology
11.09.2017 | Fraunhofer-Institut für Produktionstechnik und Automatisierung IPA

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: The pyrenoid is a carbon-fixing liquid droplet

Plants and algae use the enzyme Rubisco to fix carbon dioxide, removing it from the atmosphere and converting it into biomass. Algae have figured out a way to increase the efficiency of carbon fixation. They gather most of their Rubisco into a ball-shaped microcompartment called the pyrenoid, which they flood with a high local concentration of carbon dioxide. A team of scientists at Princeton University, the Carnegie Institution for Science, Stanford University and the Max Plank Institute of Biochemistry have unravelled the mysteries of how the pyrenoid is assembled. These insights can help to engineer crops that remove more carbon dioxide from the atmosphere while producing more food.

A warming planet

Im Focus: Highly precise wiring in the Cerebral Cortex

Our brains house extremely complex neuronal circuits, whose detailed structures are still largely unknown. This is especially true for the so-called cerebral cortex of mammals, where among other things vision, thoughts or spatial orientation are being computed. Here the rules by which nerve cells are connected to each other are only partly understood. A team of scientists around Moritz Helmstaedter at the Frankfiurt Max Planck Institute for Brain Research and Helene Schmidt (Humboldt University in Berlin) have now discovered a surprisingly precise nerve cell connectivity pattern in the part of the cerebral cortex that is responsible for orienting the individual animal or human in space.

The researchers report online in Nature (Schmidt et al., 2017. Axonal synapse sorting in medial entorhinal cortex, DOI: 10.1038/nature24005) that synapses in...

Im Focus: Tiny lasers from a gallery of whispers

New technique promises tunable laser devices

Whispering gallery mode (WGM) resonators are used to make tiny micro-lasers, sensors, switches, routers and other devices. These tiny structures rely on a...

Im Focus: Ultrafast snapshots of relaxing electrons in solids

Using ultrafast flashes of laser and x-ray radiation, scientists at the Max Planck Institute of Quantum Optics (Garching, Germany) took snapshots of the briefest electron motion inside a solid material to date. The electron motion lasted only 750 billionths of the billionth of a second before it fainted, setting a new record of human capability to capture ultrafast processes inside solids!

When x-rays shine onto solid materials or large molecules, an electron is pushed away from its original place near the nucleus of the atom, leaving a hole...

Im Focus: Quantum Sensors Decipher Magnetic Ordering in a New Semiconducting Material

For the first time, physicists have successfully imaged spiral magnetic ordering in a multiferroic material. These materials are considered highly promising candidates for future data storage media. The researchers were able to prove their findings using unique quantum sensors that were developed at Basel University and that can analyze electromagnetic fields on the nanometer scale. The results – obtained by scientists from the University of Basel’s Department of Physics, the Swiss Nanoscience Institute, the University of Montpellier and several laboratories from University Paris-Saclay – were recently published in the journal Nature.

Multiferroics are materials that simultaneously react to electric and magnetic fields. These two properties are rarely found together, and their combined...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

“Lasers in Composites Symposium” in Aachen – from Science to Application

19.09.2017 | Event News

I-ESA 2018 – Call for Papers

12.09.2017 | Event News

EMBO at Basel Life, a new conference on current and emerging life science research

06.09.2017 | Event News

 
Latest News

Rainbow colors reveal cell history: Uncovering β-cell heterogeneity

22.09.2017 | Life Sciences

Penn first in world to treat patient with new radiation technology

22.09.2017 | Medical Engineering

Calculating quietness

22.09.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>