A Medical Device Daily

Genzyme (Cambridge, Massachusetts) reported that it has received approval to expand the CE-mark labeling for Synvisc (hylan G-F 20) to include treatment of pain due to osteoarthritis (OA) of the ankle and shoulder. Approval of this new label will broaden the use of Synvisc beyond its established use in knee and hip OA patients, Genzyme said. Synvisc has been shown in European clinical trials to provide up to 12 months of pain relief in knee OA.

Genzyme said it will begin marketing Synvisc immediately in the European Union with its new label.

The approval of Synvisc in the ankle and shoulder follows clinical studies conducted in Europe in these two joints. The studies were prospective, multi-center, open investigations conducted throughout Europe. Both studies found treatment with one or two injections of Synvisc to be well-tolerated, the data showing that Synvisc significantly decreases ankle and shoulder pain due to OA.

Genzyme said that data from the ankle study have been accepted for presentation at the annual meeting of the American College of Rheumatology (ACR; Atlanta) this fall in Washington, and data from the shoulder study at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS; Rosemont, Illinois) in San Diego, February 2007. Both abstracts will be presented at the annual congress of the Osteoarthritis Research Society International (OARSI; Mount Laurel, New Jersey) in Prague in December.

The company also said that recently reported data from an independent clinical study found Synvisc to be superior in magnitude and duration of pain relief, functional improvement and patient satisfaction to another viscosupplementation product in treating patients with OA of the knee.

Ann Merrifield, president of Genzyme Biosurgery , said, “We are eager to begin our marketing and sales effort and will continue to emphasize the strong clinical data that Synvisc has now generated in four major joints.”

Genzyme says it is using evidence-based medicine to broaden Synvisc label claims to establish its efficacy and safety. In addition, two meta-analyses in 2004 and 2006 also affirmed the benefit of Synvisc and its class of viscosupplements, using research methodologies providing tools to evaluate new treatments using an evidence-based approach.

Synvisc is marketed in more than 60 countries and has been used to treat more than three million people, Genzyme said. Synvisc is currently approved in the U.S. for treatment of pain due to OA of the knee, and the company is pursuing a label expansion in the U.S. that would include the hip indication.

Kodak lands Estonia contract

East-Tallinn Central Hospital (Tallinn, Estonia) has awarded Kodak (Rochester, New York) a contract for PACS and Enterprise Information Management Solutions for the Baltic e-Health project.

The Baltic e-Health project is part-funded by the European Regional Development Fund, and covers the Baltic Sea Regions, to encourage e-Health as a way to enhance access to healthcare in rural areas and thereby counteract rural migration. This will be achieved by creating the Baltic Health Network, a large transnational IT infrastructure for e-Health, the first cross-border health data network of its kind across the Baltic countries connecting more than 200 hospitals and 6,000 general practitioners.

Initially, Kodak will deliver PACS, remote reporting and archiving solutions to the East-Tallinn Central Hospital to facilitate participation in two pilot projects, in radiology and ultrasound. The eRadiology pilot will link the East-Tallinn Central Hospital, the Funen Hospital (Odense, Denmark) and the Vilnius University Hospital (Vilnius, Lithuania). During the pilot phase, radiologists from Estonia and Lithuania will test e-communication and the network infrastructure by remotely reporting on studies from the Funen Hospital.

The eUltrasound pilot will test communication between East-Tallinn, Norrlands University Hospital (Umea, Sweden), and the St.Olav’s Hospital (Trondheim, Norway).

Kodak will work with Danish company Medical Insight (Hedehusene Denmark), specializing in systems for managing and distributing patient images and healthcare data, across disparate technology environments.

“We chose Kodak because of its leading market position and wealth of experience in national and regional e-health projects,” said Dr Peeter Ross, director of R&D, East-Tallinn Central Hospital. “Here in Estonia we . . . required a supplier who could match our aspirations to participate in the wider European e-Radiology market.

Kodak says that, to date, more than 250 European sites handling over 10 million annual studies are managed by Kodak Carestream Solutions that enhance communication of patient data across the continuum of care, enabling the right information to be available wherever needed and regardless of where it is stored or generated. Kodak said its involvement in the Baltic e-Health Project is the latest in a series of recent e-Health contracts awarded to it for Carestream Solutions.

Biofisica wins CE-mark for POSiFECT RD

Biofisica (Atlanta), a high-tech wound care company, reported receiving CE-marking for its POSiFECT RD Bio-Electric Stimulation Therapy, its flagship wound care product.

Biofisica worked with the British Standards Institute throughout the conformity assessment process, and that it now plans to launch POSiFECT RD in the UK in the next 90 days, followed by staged rollouts in France, Germany and the Nordic region.

POSiFECT RD (RD referring to the dressing’s round shape) is the first device available that combines two technologies — moist wound-care dressing and electrical stimulation — in a disposable sterile dressing that facilitates healing, Biofisica said.

“We can now begin to provide this pioneering therapeutic option to tissue viability nurses throughout the UK for the care of their patients,” said Rafael Andino, president of Biofisica. “It is intensely satisfying to develop a technology that . . . has the potential to help heal non-healing chronic wounds instead of simply ‘managing the wound’ as other products do.”

Biofisica says that the bio-electric technology associated with POSiFECT dovetails with normal tissue repair by stimulating the wound bed as would the body’s own “current of healing.” POSiFECT RD is indicated for managing chronic wounds where conventional therapies have failed.

The company also has offices in the UK.