A Medical Device Daily

In partnership with Germany's Society for the Promotion of Medical, Biological and Environmental Technologies, the Hohenstein Institute (Boennigheim, Germany/Elon, North Carolina) has developed textile technologies that it says will improve the future of wound treatment.

According to the institute, which is a leading global textile research and testing laboratory, the new textile technology will be used in wound compresses to deliver active ingredients that encourage healing.

The technology, called Nanosol, can be adapted for different types of medicines to ensure appropriate release rates and shelf life. The Nanosol technology currently has been applied to deliver antibiotics to prevent infection, proteins to promote healing, and vitamins to encourage skin regeneration. Additional therapeutic applications are in development.

Hohenstein scientist Dr. Dirk Hoefer and his research team have developed a method to coat individual cellulose fibers with inert silicon (SiO2) and then to bind active ingredients to the silicon coating. When incorporated into a wound compress and applied, the moisture from the wound activates release of the medicine continually and directly into the wound site.

Testing conducted at the institute confirmed the delivery effectiveness of the new technology.

The institute said the project demonstrates "the enormous benefit textiles can play in the therapeutic treatment of wounds." It said that as the techniques are commercialized, efficient and cost-effective production of wound therapy systems will be possible. "Soon, wound compresses enhanced with a broad variety of active ingredients will be available to speed healing, simplify treatment, and reduce the amount of time required for care," Hohenstein said.

ISO certification for IlluminOss

IlluminOss Medical (East Providence, Rhode Island), developer of the IlluminOss Photodynamic Bone Stabilization System for orthopedic surgery, reported that it had received an ISO 13485 Certificate of Registration issued by BSI (British Standards Institute).

The certification indicates that the company has implemented a quality system that conforms to the International Organization for Standardization (ISO) standards for medical devices and is one of the key regulatory requirements for a CE mark in the European Union as well as other international markets.

ISO 13485 defines standards for the design, development, production and distribution of medical devices. It ensures conformity with specified quality controls in the development of safe and effective devices.

Bob Rabiner, founder/president of IlluminOss, said, "ISO 13485 certification represents a major milestone for IlluminOss and patients worldwide. We believe that our minimally invasive technology will fundamentally improve the treatment of hundreds of thousands of bone fractures by driving much earlier restoration of functionality, improving the durability of orthopedic repairs, decreasing pain and reducing scarring."

IlluminOss is a privately held, early-stage device company focused on developing minimally invasive orthopedic systems for the stabilization and treatment of bone fractures. The IlluminOss Photodynamic Bone Stabilization System utilizes a photodynamic (light-curable) polymer system intended to eliminate the need for traditional, inconvenient and painful methods of bone fixation with external pins, plates and screws.

The company is currently developing the IlluminOss Photodynamic Bone Stabilization System for small bones such as fractures of the hands, wrists, clavicle and arms, but it anticipates that the system also will have applications in the spine and long bones.

French center using Hi•Art system

TomoTherapy (Madison, Wisconsin) said that Centre Oscar Lambret (Lille, France) has begun treating cancer patients using the TomoTherapy Hi•Art treatment system, a CT platform-based radiotherapy solution for improved cancer care.

This is the first of two Hi•Art treatment systems that Centre Oscar Lambret has ordered. The second system will be installed later in 2009.

The decision by Centre Oscar Lambret to adopt TomoTherapy's technology follows calls for research proposals launched by the French national cancer institute, INCA, in July 2005 to promote implementation of image-guided radiotherapy technology that was not previously available in France.

To date, six centers in France have adopted TomoTherapy's solution, including: Institut Curie (Paris), Institut Bergonié (Bordeaux), Centre Paul Strauss (Strasbourg), Centre René Gauducheau (Saint Herblain) and Institut Claudius Regaud (Toulouse).

"We are extremely pleased to announce that another well-respected institution in France, Centre Oscar Lambret in Lille, has chosen to invest in the TomoTherapy platform," said Jef Van Dam, general manager of TomoTherapy EMEA. "We are privileged to be working with the Centre, and proud of TomoTherapy's growing presence within France's prestigious radiation oncology community."

Eric Lartigau, MD, PhD, professor of radiation oncology at the University of Lille and chairman of the radiation oncology department and director of research and co-operations at the Centre Oscar Lambret, said, "The choice [of TomoTherapy] was guided by the need to offer IMRT [intensity-modulated radiation therapy] treatment to our patients. The IMRT delivered by TomoTherapy was the best option for us in order to implement rapidly a modern and very efficient technique. The need to distribute very accurate dose and reduce normal tissues morbidity has been a key criteria in our choice."

"The strong interest that we see for TomoTherapy equipment in France is related to the better treatment quality and increased clinical confidence that the system's design makes possible via daily 3-D image guidance and unique dose modulation capabilities," said Patrice Lompech, sales director for TomoTherapy in France and Luxembourg.

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