A Medical Device Daily

Genzyme (Cambridge, Massachusetts) said it has received the CE mark for Synvisc-One, the single-treatment form of Synvisc (hylan G-F 20) that the company said has been shown in the European Union to provide up to six months of proven pain relief from osteoarthritis (OA) of the knee.

It said Synvisc-One is the only viscosupplementation product available in Europe that is labeled to provide this long-term duration of pain relief from a single injection.

Genzyme said it believes that Synvisc-One "will simplify osteoarthritis pain management and provide added patient convenience, while reducing the overall cost of therapy associated with multiple injections and offering a treatment option that will expand the benefits of viscosupplementation to a broader number of patients."

"The European approval of Synvisc-One is based on positive clinical data which demonstrated that combining three doses of Synvisc in a single treatment is safe and effective in providing pain relief for up to six months in patients with knee osteoarthritis," said Ann Merrifield, president of Genzyme Biosurgery, the business unit of Genzyme Corp. that manufactures and markets Synvisc.

She added: "Delivering the benefits of Synvisc through one treatment rather than three will provide additional options for physicians and their patients to reduce the cost and burden of multiple injections."

Genzyme said it also will pursue marketing approvals for Synvisc-One in wider geographies in Canada, Asia and Latin America based on the Europe CE-mark approval.

Synvisc is currently delivered through three intra-articular administrations of 2 mL each given at one-week intervals. Synvisc-One is delivered as three combined doses in a single 6 mL administration. The company said competitive injection regimens call for up to five injections.

Genzyme's regulatory filing for the CE mark was based on final data from a prospective, randomized, double-blind, placebo-controlled study that involved 253 patients at 21 sites across Europe. In this study, a statistically significant improvement in pain from osteoarthritis of the knee was observed over 26 weeks when compared to pain relief for patients receiving placebo treatment.

Statistically significant differences in favor of Synvisc-One also were observed in several secondary outcome measures of efficacy, including patient and clinician global assessments.

Data from the study were presented earlier this year at the European League Against Rheumatism annual meeting in Barcelona, Spain, and have been accepted for a podium presentation at the American Association of Orthopaedic Surgeons annual meeting in San Francisco next March, Genzyme said.

"Synvisc-One provides long-term pain relief for patients without the systemic safety risks associated with traditional OA therapies such as NSAIDs and COX2 inhibitors," stated Xavier Chevalier, MD, head of rheumatology at Hopital Henri Mondor (Creteil, France). "This is a unique opportunity for physicians to treat patients with a single injection viscosupplement that offers a very good risk-benefit profile."

Enzo Biochem plans to acquire distributor

Enzo Biochem (New York) said its Enzo Life Sciences subsidiary has signed a letter of intent to acquire 10 P's, a privately owned distributor of life science research products, with offices in Belgium serving the Benelux countries.

Upon completion of the acquisition, which is subject to definitive agreements being signed, Enzo will have local, directly owned presence from which to market its growing line of life sciences reagents and systems in those European countries.

Financial terms were not disclosed. The deal is expected to close in February.

"This proposed acquisition is one more step in our plan to build Enzo Life Sciences into a major participant in the research products global marketplace," said Barry Weiner, president of Enzo Biochem. "Our intention is to continue to evaluate and consummate additional acquisitions that fit in with the infrastructure we have built for this division."

Carl Balezentis PhD, president of Enzo Life Sciences, said that10 P's "represents a strategic step in our plan to strengthen our global direct sales effort, which is being led by our recent Axxora acquisition. 10 P's not only will provide us with the opportunity to improve and expand relationships with the end-users of our products, but also affords us with an important local presence in a key European region."

He said that in addition, "10 P's enjoys exclusive relationships with other reagent manufacturers that will provide Enzo with the opportunity to further expand our product line."

"We are [pleased] that our company will be joining an organization that shares our focus of providing innovative, high-quality research reagents," said Jean-Paul Sanders, president of 10 P's. "Additionally, we are pleased that Enzo Life Sciences will retain our employees, and that we will work together to bring growth to all of the company's product lines."

German hospital gets TomoTherapy system

TomoTherapy (Madison, Wisconsin) said that Helios Hospital Berlin-Buch has installed the TomoTherapy Hi-Art treatment system for advanced cancer care.

The company said the hospital wanted a rapid installation process, and it responded. The order was placed on Nov. 16 and the system was fully installed one month later. The first patient treatments are scheduled to begin the week of Jan. 21, TomoTherapy said.

Helios Hospital Berlin-Buch is the newest hospital constructed by the Helios Hospital Group, which TomoTherapy described as "the largest, most medically advanced hospital group in Germany." Helios Hospital Group is a subsidiary of Fresenius ProServe, an international healthcare services and facilities management firm.

"The Helios Hospital Group is an ideal partner for us," said Rik Van den Neste, MD, director of European sales for TomoTherapy. "They are a leader in the private hospital movement in Germany and committed to the most up-to-date medical care."

Helios Hospital Berlin-Buch will become the seventh facility in Germany to install the TomoTherapy Hi-Art treatment system. The system was introduced in the U.S. in July 2003, and today there are more than 150 Hi-Art radiation therapy systems in use around the world.

The Hi-Art system combines integrated CT imaging with conformal radiation therapy to deliver sophisticated radiation treatments with speed and precision, TomoTherapy said, while reducing radiation exposure to surrounding healthy tissue.