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NOTE: This report has been prepared to provide rapid advice of the Resolutions of the Advisory Committee on Medical Devices (ACMD) at its recent meeting. It should not be assumed that advice given to the TGA represents the decisions of the TGA.
The 2011/3 meeting of the ACMD was held on 16 September 2011. The recommendations listed below were supported by the ACMD.
ACMD 2011/3 meeting report and resolutions
Resolution: 2011/9
ACMD advised:
- The application from AMO Australia Pty Ltd for Conformity Assessment Certification for Healon Endocoat (Vitrax II) (a viscoelastic solution containing sodium hyaluronate) manufactured by Abbott Medical Optics Inc (USA) has demonstrated compliance with the essential principles for safety, quality and performance (Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002) subject to the resolution of any issues relating to sterilisation.
Resolution: 2011/10
ACMD advised:
- The application from Abbott Vascular Division of Abbott Australasia Pty Ltd for Conformity Assessment Certification for Xience Prime Everolimus Eluting Coronary Stent System, Xience Prime SV Everolimus Eluting Coronary Stent System and Xience Prime LL Everolimus Eluting Coronary Stent System manufactured by Abbott Vascular (USA) has demonstrated compliance with the essential principles for safety, quality and performance (Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002) for improving coronary luminal diameter in the following:
- Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions
- For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset
- For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels (Reference Vessel Diameter ≤ 2.77mm), and in lesions where treatment results in the jailing of side branches (Lesions with a side branch < 2mm in diameter or ≥2 mm in diameter with an ostial stenosis <50%) and for the treatment of elderly patients (age ≥65) and women (female gender).
Resolution: 2011/11
ACMD advised:
- The application from Biotronik Australia Pty Ltd for Conformity Assessment Certification for Linoxsmart S DX 65/15, Linoxsmart S DX 65/17 (STEROID-ELUTING ICD LEADS) manufactured by Biotronik SE & Co KG (Germany) has demonstrated compliance with the essential principles for safety, quality and performance (Schedule 1, Therapeutic Goods (Medical Devices) Regulations 2002) subject to satisfactory data from the current clinical trial.