A Medical Device Daily

Smith & Nephew's Orthopaedic Reconstruction & Trauma business (S&N; Memphis, Tennessee) and Smith & Nephew Orthopaedics KK Japan has reported the receipt of Japanese regulatory C1 Category Reimbursement approval for its Oxinium oxidized zirconium technology.

S&N's Genesis II Oxinium Total Knee System is the first orthopedic product to gain the C1 Category reimbursement in Japan, the world's second-largest orthopedic market after the U.S.

The company said that Japan's C1 classification "rewards innovative products with a higher reimbursement price and is reserved for those products where the advantages are recognized" by the MHLW [Ministry of Health, Labour and Welfare] over other available products."

Smith & Nephew Orthopaedics KK Japan received regulatory approval for the Genesis II Oxinium Total Knee System in Japan on Feb. 18.

Oxinium is a proprietary transformed metal alloy with a ceramic bearing surface that S&N said combines low friction and wear resistance technology with the strength of a metal implant.

"It is this ceramic surface that gives Oxinium its advantages over CoCr implants," the company said in a statement. "Because only the surface is changed, the rest of the component is still metal and therefore the implant retains its overall strength."

The Oxinium material presently is used for total hip and total knee joint replacements.

"Getting the Genesis II Knee System with the Oxinium Technology approved in Japan is a great opportunity for Smith & Nephew Orthopaedics KK Japan to offer a new state-of-the-art material to the Japanese patients and the surgeons who perform these procedures," said Joseph DeVivo, president of Smith &Nephew Orthopaedic Reconstruction and Trauma.

Hailing the MHLW for understanding the benefits of Oxinium, he said the company was pleased by the C1 Category reimbursement, "which recognizes the importance in making these types of new products available to the Japanese patient."

Smith & Nephew specializes in orthopedic reconstruction, orthopedic trauma & clinical therapies, endoscopy and advanced wound management products.

Israel's Hadasit tests double lumen catheter

Hadasit (Ein Kerem, Israel) reported the successful pre-clinical testing of a prototype of the Double Lumen PCI Guiding Catheter for use in the treatment of coronary artery disease.

Unlike conventional catheters, the Double Lumen PCI Guiding Catheter has two lumens rather than one. The second lumen allows for a continuous medication infusion to the coronary artery during percutaneous coronary intervention (PCI), the part of the procedure when the narrowed coronary artery is dilated.

"The potential impact of this device is far-reaching," said Dr. Rafi Hofstein, Hadasit president/CEO. "The Double Lumen PCI Guiding Catheter has potential to change existing coronary artery PCI protocol for the better and to positively affect millions of patients worldwide."

He said the next step is to build a prototype for use in a proof-of-concept study in man and added that Hadasit is seeking partners to help finance the initiative.

Hadasit is the technology transfer company of Hadassah Medical Organization in Jerusalem, Israel, and promotes and commercializes HMO's continuously generated intellectual property and R&D capabilities.

Largest order placed for female condoms

The Female Health Co. (FHC; Chicago), which manufactures and markets the FC and FC2 Female Condoms, said it has received an order for 4.3 million FC2s from the Papua New Guinea-Australia HIV and AIDS program.

This is the largest order received to date for FC2, FH's second-generation female condom. The Australian National AIDS Council Secretariat will coordinate the distribution of FC2, starting in October, by the Department of Health and the non-government organizations.

The company said there is widespread demand for the female condom in Papua New Guinea, which was first introduced there in the 1990s.

Mike Pope, vice president of The Female Health Co.'s UK and Malaysia operations, said, "This order is an indication of [our] female condom's increasing acceptance as an effective tool for prevention of HIV."

Papua New Guinea accounts for 70% of all HIV infections in the Australasia region. Funding for the FC2 order is from AusAID, the Australian government's Overseas Aid Program.