A Medical Device Daily

Spine and orthopedic biosurgery firm Orthovita (Malvern, Pennsylvania) reported receiving CE-mark approval for its Vitagel Surgical Hemostat product and Cellpaker plasma collection system. The approval allows the company to market Vitagel as a surgical hemostat in Europe.

Vitagel is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. The Cellpaker plasma collection system is used in conjunction with Vitagel.

Orthovita said Vitagel “stimulates hemostasis and healing through multiple mechanisms, amplifying the patient’s own biology. Vitagel [combines] a collagen/thrombin suspension with the patient’s own plasma. The resultant fibrin/collagen clot stems bleeding and provides a robust 3-D matrix for soft tissue healing.

Antony Koblish, president/CEO of Orthovita, said, “We believe that Vitagel is the only surgical hemostat using collagen and thrombin pre-blended directly into the product that is currently approved for use in Europe. We ... plan to launch Vitagel in the European marketplace this September.” Orthovita develops tissue-engineered products. Its synthetic-based biomaterials products are for use in spine surgery, the repair of fractures and a broad range of clinical needs in the trauma, joint reconstruction, revision and extremities markets.

The company’s Vitoss bone graft substitute technology platforms offer synthetic alternatives to the use of autograft or cadaver-based bone material. Our longer-term U.S. clinical development program is focused on our internally developed Cortoss bone augmentation material technology platform, primarily designed for injections in osteoporotic spines to treat vertebral compression fractures.

Air Liquide grows its homecare business

Noting that homecare for chronic respiratory diseases is experiencing strong global growth, Air Liquide (Paris) reported that it has followed its acquisition of Linde UK last May by making strategic acquisitions in the homecare sector, thus continuing its growth strategy by consolidating its positions in home markets and expanding into new areas.

The acquisition of Linde UK enabled the company to enter the UK hospital and homecare markets, and it now has added five regional companies in Germany, mainly located in Bavaria and the Berlin area.

Air Liquide said it now is No. 1 in the German homecare market, which it described as “the leading potential European market for growth in the group’s Healthcare Business Line.” The newly acquired companies serve more than 15,000 patients suffering from chronic respiratory illnesses or sleep apnea.

The company said it has made nine such acquisitions in Germany in the past 18 months.

Air Liquide recently made its first acquisition in homecare in China, by taking over Celki International, a company established in Hong Kong and in the south of China. The 130-employee firm supplies respiratory products and services to the Chinese market. Air Liquide said Celki will serve as a base for expansion, to identify and seize opportunities in the new homecare market in that country.

Jean-Marc de Royere, senior vice president in charge of the Healthcare World Business Line for Air Liquide, said, “These acquisitions illustrate the strategy for homecare decided in 2005, by strengthening our European bases and preparing for establishment in emerging markets. Our experience of integrating acquired companies in our network has been very positive to date and we fully expect this progress to continue.”

CE mark for Gebauer SL Keratome

Gebauer (Neuhausen, Germany) reported that its Gebauer SL Keratome for LASIK and Epi-LASIK procedures has received CE-mark approval.

All product components making direct patient contact are single-use and sterile, so the Gebauer SL Keratome reduces potential problems due to wear and repeated cleaning and helps to decrease cycle times in the operating room, the company said.

It added that the Gebauer SL “complies with the strict sterilization rules now applicable in many countries.”

Gebauer said the ergonomic and lightweight SL Handpiece enables the surgeon to have a motionless hand while performing the surgical procedure.

“The SL Keratome is the product breakthrough that refractive surgeons have been asking for — simplicity, versatility and single-use at a small investment,” said Managing Director Steffen Gebauer. “The motionless handpiece grip, simple foot pedal control, intelligent Click-And-Go set-up and the complete single-use set with stainless steel vacuum ring are a unique product package.”

Two BARA-MED sales

Environmental Tectonics (ETC; Southampton, Pennsylvania) said it has contracted with an unnamed medical equipment distributor in an unspecified former Soviet republic for the delivery and installation of two BARA-MED monoplace hyperbaric chambers.

The company said this sale will increase ETC’s presence in the hyperbaric medical field outside the U.S./North America from 19 to 20 countries. This, however, will be the first country that will use the Russian language for the operator interface with BARA-PRESS, a Windows-based software control system with full semi-automatic override and manual backup.

ETC said this system “serves to maximize operational efficiency and enhance patient comfort and safety by allowing chamber technicians to focus their attention on patients, not on the equipment, clock/timer, or records keeping.”

Gene Davis, president of ETC’s Biomedical Systems Division, said, “Being able to offer our BARA-PRESS control system in Russian will potentially open up many more markets in the numerous countries in the former Soviet Union.”

Digilab BioVisioN (Hannover, Germany) said it has received ISO 9001:2000 certification by the T V Rheinland organization. The certification covers Digilab’s business of offering research collaborations and services encompassing the discovery of peptide biomarkers and the characterization of proteases and their inhibitors using the firm’s Peptidomics-Technologies and pre-analytical sample prep products.

The company said it has been a global leader in molecular spectroscopy systems for more than 40 years, and is a developer of differentiated applications for the life sciences research and in vitro diagnostics markets.