A Medical Device Daily

Royal Philips Electronics (Eindhoven, the Netherlands) reported that it has been awarded two contracts to supply its Achieva 7.0T (Tesla) MRI whole body research systems to Leiden University Medical Center and University Medical Center Utrecht.

It said that these new systems, the first 7.0T MRI systems in the Netherlands, will support the establishment of a national Virtual Institute for Seven Tesla Applications (VISTA), a partnership with Dutch universities for the exploration of the clinical benefits of ultra-high field MRI. Philips did not disclose the value of the contracts.

Philips said the Achieva 7.0T is capable of producing a level of imaging detail allowing clinical researchers to improve their understanding of physiology and cognitive processes of the brain and of neurological diseases, such as Alzheimer's, Parkinson's, epilepsy and multiple sclerosis, “with excellent accuracy.”

Researchers at participating Dutch universities and Philips Medical Systems will collaborate with VISTA to develop ideas and share information through annual workshops, forums, panels and internet communications that will further advance applications of this new medical technology.

“The advanced capability of the Philips Achieva 7.0Tesla MR research system will enable us to increase our knowledge and understanding of some of medicine's most challenging areas,” said Peter Luyten, senior MR researcher at the University Medical Center Utrecht. “Although ultra high-field MR research is still in its early stages, it is already clear that it could help provide significant insights into the diagnosis, intervention and treatment of degenerative neurological diseases. And ultimately many new applications outside the brain will become possible by means of this new technology platform as well.”

“Our intention is that VISTA will become a global center of excellence for ultra high-field MR research, capitalizing on expertise from within the Netherlands as well as attracting researchers from across the world that will lead to innovations that will have direct clinical benefits,” Luyten said.

HydraFlex system gets first use in Germany

Raymedica (Minneapolis) reported that the first device using its HydraFlex Nucleus Arthroplasty System was implanted at Kreiskrankenhaus (Bogen, Germany), last month by Dr. Rudolph Bertagnoli, one of three international surgeons participating in a Raymedica-sponsored clinical evaluation of the HydraFlex. The system is intended to provide safety and effectiveness data regarding this emerging technology designed specifically for use in what is called a less-invasive anterior lateral retroperitoneal approach (ARPA).

The HydraFlex System incorporates instrumentation that allows controlled repeatability, reproducibility and permits consistency of implantation. The ARPA allows a more thorough, consistent nucleus cleanout and the ability for closure of the annular incision. Also of importance is that the ARPA is less destabilizing to the lumbar motion segment than the traditional posterior approach, according to Raymedica.

“I believe HydraFlex represents the next generation in nucleus arthroplasty technologies,” said Bertagnoli, chief of the Spine Department Klinikum St. Elisabeth (Straubing, Germany). “Ease of insertion and intraoperative versatility make it a very welcome advancement to the surgical options spine surgeons currently possess. I am very excited to participate in its clinical evaluation.”

The HydraFlex device is designed with the Raymedica's pre-formed hydrogel that it says has been used in more than 4,000 patients more than 10 years. Using the PDN-SOLO family as a platform, a program consisting of a more anatomic shape of the implant for a better fit and fill of the disc space, softer core to reduce the risk of subsidence, faster hydration to allow faster stabilization, increasing the hydrogel footprint to reduce pressure on the vertebral endplates, coupled with elegant instrumentation, has resulted in the HydraFlex NAS.

“Raymedica continues to deliver innovative systems that maintain or restore motion preservation of the spine,” said John Viscogliosi, CEO and chairman and CEO of Raymedica. “Nucleus Arthroplasty procedures are one of the fastest growing segments of spine surgery, and HydraFlex will provide spine surgeons with a unique nucleus replacement option.”

Raymedica bills itself as the pioneer in nucleus arthroplasty, having developed the world's first nucleus replacement device in 1996.

EU license issued to Aastrom unit

Aastrom Biosciences (Ann Arbor, Michigan) reported that it has received a human pharmaceuticals manufacturing license, through its wholly owned subsidiary, for the production of the company's Tissue Repair Cell (TRC) products. Aastrom said that this is the first manufacturing license issued to it in the European Union (EU) and enables it to produce its human cell and tissue products for clinical use in compliance with EU regulations.

The newly-licensed manufacturing facility was established as a collaboration at the Fraunhofer Institute for Interfacial Engineering and Biotechnology (Fraunhofer IGB; Stuttgart, Germany).

Aastrom said it is currently involved in several clinical trials that use TRC-based products for tissue regeneration. The new manufacturing site will be used to expand these studies, and will serve as a pilot facility for centralized manufacturing that is a requirement of the company's commercialization strategy. The TRC manufacturing process, including Aastrom's patented AastromReplicell System, has been installed and validated at the German site, in compliance with EU Good Manufacturing Practices.

“Our successful establishment of a licensed centralized manufacturing facility to produce Aastrom's TRC products for tissue regeneration is an important operational milestone in our commercial business strategy,” said R. Douglas Armstrong, PhD, CEO and chairman of Aastrom.

The licensed European facility incorporates the company's technologies for automated, process-controlled production of reliable, patient-specific cell-based products, overcoming what has been a hurdle in the cell-based product industry. Traditional pharmaceuticals are typically produced in a single lot, and used for many thousands of patients; this manufacturing model cannot be used for autologous cell/tissue products.

Each autologous TRC product is manufactured for a specific patient.

Aastrom has pioneered a scalable cell/tissue manufacturing process that aids regulatory compliance; traditional cell culture production approaches are manual and lack the advantages of Aastrom's technology.

The Fraunhofer IGB provides R&D solutions in the fields of health, environment and technology.