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www.fdanews.com/articles/63380-australian-group-wants-government-to-create-cardiac-spinal-and-eye-device-registries

AUSTRALIAN GROUP WANTS GOVERNMENT TO CREATE CARDIAC, SPINAL AND EYE DEVICE REGISTRIES

October 17, 2006

The Australian Health Insurance Association (AHIA) Oct. 16 called for the implementation of government-funded national cardiac, spinal and lens registries after further information came to light about joint replacement surgery and prosthetics in an article published by the National Joint Replacement Registry.

The AHIA wants the Australian government to implement compulsory clinical testing for all new cardiac, spinal and lens prostheses, and for the results to be approved by Australian regulators. The AHIA is also calling for clinical testing within 12 months for prosthetic devices currently in use.

The AHIA's Health Alerts website (www.healthalerts.com.au (http://www.healthalerts.com.au)) pointed to reports showing a potential increased risk of blood clots (thrombosis) for patients implanted with drug-eluting stents.

At least two firms, Boston Scientific and Cordis, a Johnson & Johnson (J&J) company, are facing questions about the long-term safety of their drug-eluting stents after researchers at the World Congress of Cardiology concluded there is an increased risk of patients developing thrombosis the longer the devices remain implanted.

Reports on the AHIA Health Alerts website also question the efficacy of blue-blocking intra-ocular lenses used in cataract surgery and intra discal electrothermal annuloplasty treatments for chronic back pain.