Advanced Vertebral Solutions' Spinal Implant Made of Solvay's Zeniva® PEEK Receives FDA Clearance

Advanced Vertebral Solutions (AVS), a supplier of minimally invasive spinal implants and delivery systems, has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its new Steerable TLIF spinal fusion implant made of Zeniva® polyetheretherketone (PEEK) resin from Solvay Advanced Polymers, LLC. Zeniva® PEEK - part of Solvay's Solviva® line of biomaterials - has a modulus very close to that of bone plus excellent toughness and fatigue resistance.
The EXPRESS IBFD™ TLIF implant, made from 30- and 40-mm-diameter Zeniva® PEEK rod stock, is an implant for interbody fusion of the anterior column of the spine. These implants are hollow so that bone can grow through the device, fusing the adjacent bony surfaces of the vertebrae. AVS has developed a unique "active steering" technology that minimizes instrument exchanges and simplifies the minimally invasive surgical technique, thereby enabling its rapid adoption among spine surgeons.

"Zeniva® PEEK provides the exceptional properties that are required of a high-precision implant in this critical application." said Mike Dugery, President of Advanced Vertebral Solutions.

Zeniva® PEEK is a comparable or better-performing alternative to metals such as titanium for these intervertebral implantable devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. Based on biocompatibility testing, Zeniva® PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity. It also boasts high strength and stiffness and has radiolucent properties which permit x-ray procedures. Advanced Vertebral Solutions uses Zeniva® PEEK rod stock and performs high-precision machining to produce a full range of sizes and configurations.

"We're excited about the commercial adoption of Zeniva® PEEK for this unique spinal fusion implant," said Shawn Shorrock, Global Healthcare Market Manager for Solvay Advanced Polymers. "We've made significant investments and performed all applicable required testing to ensure that our Zeniva® PEEK meets or exceeds the critical regulatory performance standards set by the FDA for this application."

Zeniva® PEEK and the entire line of Solviva® Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay's biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.

Solvay is currently in active product trials with several medical device manufacturers, not only with Zeniva® PEEK, but using the broad range of Solviva® Biomaterials.

In addition to Zeniva® PEEK, Solvay's Solviva® Biomaterials line includes Proniva® self-reinforced polyphenylene (SRP); Veriva® polyphenylsulfone (PPSU); and Eviva® polysulfone (PSU). These sterilizable products are available in resin for injection molding or extrusion.

The British Plastics Federation Supports EFSA's Re-Confirmation on the Safety of BPA

The British Plastics Federation (BPF) has welcomed the European Food Standards Agency's (EFSA) confirmation of the safety of Bisphenol A.

The EFSA research, spearheaded by the European Commission, based on 'a detailed and comprehensive review of recent scientific literature and studies on the toxicity of bisphenol A at low doses' concludes that 'they could not identify any new evidence which would lead them to revise the current Tolerable Daily Intake for BPA of 0.05 mg/kg body weight set by EFSA in its 2006 opinion and re-confirmed in its 2008 opinion.' The review also highlighted that 'data currently available does not provide convincing evidence of neurobehavioural toxicity of BPA.'

Philip Law, Director of Public & Industrial Affairs at the BPF said, "The Bisphenol A issue has become highly politicised in recent years and in some countries has become divorced from the reality and nature of its use. The EFSA's ruling on the safety of BPA provides a solid endorsement which should set consumers minds at ease. Plastics based on Bispehnol A are perfectly safe and not only are they endorsed by the European Food Standards Agency but also by a raft of other independent bodies including the NHS."

The BPF fully supports the findings of the EFSA review and its conclusions which provide an authoritative approval of the continued safe use of products produced using Bisphenol A.

Natural fibres from banana plant waste

The EC-funded BADANA project aims to develop procedures for the extraction of natural fibre from banana plant waste. The fibres will be used to develop thermoplastic composite products for the automotive industry.

The Badana project, led by consultancy Smithers Rapra, is half way through its two-year funding period and the first prototype of the multi-phase decorticating machine (MPDM) which automates the process of extracting fibre from the leaves of the banana plant has been developed.

Work has also been undertaken to analyse the fibres of a variety of banana species grown in the Canary Islands. This has helped in the development of formulations for modifying the fibre surface in order to ensure good adhesion between the fibres and the polymer with which they are compounded.

Successful candidate formulations have been selected and lab scale trials, involving injection moulding and rotational moulding of the developed plastic composites, have been carried out. The results have shown good behaviour of the fibre compared to other natural fibres in terms of mechanical properties and coupling to the plastic matrix, as well as resistance to degradation under processing conditions.

In the next few months the BADANA project will focus on completing the lab scale trials of the MPDM and optimising the machine design. Work will be undertaken to manufacture the composites on an industrial scale to enable industrial trials to take place. Parts such as components for car doors, washing machines and kayaks are expected to be tested at this stage of the project.

The Badana project will run until June 2011. The project partners are: BSH Electrodomésticos (Spain), Colorex Master Batches (Netherlands), Consejo Superior de Investigaciones Científicas (Spain), Grupo Antolín Ingeniería (Spain), Grupo Regional de Cooperativas Plataneras del Archipielago Canario (COPLACA) (Spain), PEVA (Hungary), Queen’s University Belfast (UK), Rototek (UK), Sivel (Bulgaria), Universidad de Las Palmas de Gran Canaria (Spain), and Universidad de Zaragoza (Spain).

Efficient Rovings for Wind Turbine Blades

For wind turbine blade applications, glass fiber yarns and reinforcements producer AGY has made available boron-free S-1 HM™ rovings suitable for both epoxy and polyester resin systems. According to ASTM calculations, in comparison to typical E-Glass products which offer tensile modulus of approx 70-75GPa, the S-1 HM™ rovings exhibit 90GPa tensile modulus of glass fibers, 20% more tensile modulus, 50 and 20% increase in compressive strength and compressive modulus, respectively, and consequently shows fatigue improvement by nearly 10-times. Added length of wind turbine blades allow the turbine to operate at full efficiency, thus reducing the cost of the electricity consumed, and also by and large make the complete wind turbine structure cost effective. The direct roving product form is tailored for standard conversion to unidirectional fabrics and prepregs, and multiaxial fabrics.

Evonik Introduces a New, Tougher Grade of PEEK

Evonik Industries have launched a new grade of PEEK, the VESTAKEEP® 5000 G that, according to the company, possesses 20 percent higher impact strength than any previously used PEEK grade. The new VESTAKEEP® is of particular interest for suppliers to the oil and gas industries, who work in the temperature range -40 to 150°C and sometimes significantly beyond these limits. The high elastic modulus of the new PEEK therefore meets increasing requirements with regard to long-term exposure to high temperatures.

Evonik claims that its partners and customers, who have tried out the new PEEK have been able to achieve higher tear strengths with VESTAKEEP® 5000 G than with any other PEEK material on the market.

A concrete example of an application is provided by very large gasket rings with diameters of up to 2000 mm. In the HCM process, the gasket rings formerly used to break during the attempt to press them into the cavity of the metallic base plate. A similar situation arose in the production of rings by the extrusion technique: Production previously failed because gravitational forces made a circular geometry of large diameter impossible. VESTAKEEP® 5000 G can withstand such stresses and large rings are easier to produce.

Ski Socks & Ultra Durable Travel Bags Made from Arkema's Biosourced PA 11 to Hit the Market

One year after the market launch by Arkema of its Rilsan® 11 biosourced polyamide grade for the spinning of high performance synthetic textile fibers, the very first manufactured articles are entering the market: ski socks by Monnet, the French sports socks specialist, and a range of ultra durable luggage made from textiles by UNITIKA, a Japanese company specializing in technical fibers.

Last year Arkema presented at the TECHTEXTIL tradeshow a specific grade in its Rilsan® PA11 range of technical polymers derived 100% from castor oil, for extrusion into textile fibers. Just over a year later, articles made of Rilsan® featuring outstanding durability are about to enter the market.

Monnet, the famous sports and outdoor socks brand, have added to its "Green Vert" catalogue a range of new sports socks made of Rilsan® designed jointly with SOFILA, the French nylon yarn spinning specialist who recently developed Rilsan® PA11 fibers. These ski socks are typically very soft to the touch, lightweight and very comfortable, and offer natural bacteriostatic and thermoregulating properties. Tested by many manufacturers within the textile sector, Rilsan® PA11 fibers from SOFILA are soon to be used in many other hosiery brands.

In another sector, UNITIKA, a Japanese company specializing in technical fibers for garment and luggage manufacture, have contributed to the design of a new luggage range entirely manufactured from Rilsan® fiber. Thanks to Rilsan® 11, the outstanding characteristics of these bags include superior sturdiness and wear resistance.

Rilsan® PA11 production requires less fossil energy and entails lower CO₂ emissions than the production of polymers of fossil origin. Arkema continues its development work on its biosourced polyamide in order to target new markets in which ecological challenges and a quest for technical performance have become a genuine concern as well as a differentiating factor.

Polymer-Treated Anti-Microbial Hospital Curtains

With an intention to eliminate hospital-acquired infections caused by harmful microorganisms such as viruses, pathogens, molds and fungi that come into contact with the curtains installed in the hospital premises, Nano Mask Inc has unwrapped antimicrobial curtains. The curtains are developed using the nano silver technology. As part of this technology, an antimicrobial colloid composed of silver nanoparticles is treated with polymers.

Charged magnetic waves coming out of silver nano particles not only kill the viruses, they also stop them to reproduce further. Nano silver technology is tested to have the ability to eradicate Staphylococcus aureus and its sub-species ATCC 6538P, Klebsiella pneumonia and gram negative ATCC 4352. The curtains are also flame-, mildew- and dust proof; anti-static; disposable and recyclable. Presently available in the US and Europe, the curtains come in three different styles and 13 different colors.