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 recommendations made to the TGA represent the decisions of the TGA.
The 2010/2 meeting of the ACMD was held on 18 June 2010. ACMD resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA. These recommendations for approval may be subject to specific conditions.
2010/2 meeting report and resolutions
RTI Biologicals Sterling Bovine Bone
Emergo Asia Pacific P/L
- an application by Emergo Asia Pacific Pty Ltd for the provision of a conformity assessment certificate for the Sterling Wedges, Sterling Cancellous chips, Sterling Cancellous cubes, Sterling Cancello-Pure Wedges, Sterling Interference screw ST and Sterling Interference screw HT, and CopiOs Wedges, CopiOs Cancellous chips and CopiOs Cancellous cubes intended for use as follows:
- The Sterling Screws (ST) are intended to provide interference fixation of femoral and/or tibial tunnels in an anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction using a soft tissue graft.
- The Sterling screws (HT) are intended to provide interference fixation in an interior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction using a bone-tendon-gone graft.
- The other "void filling" products are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed in bony voids or gaps of the skeletal system (e.g. extremities, spine, ilium and/or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The products are intended to provide a void filler that remodels into the recipient's skeletal system.
Outflow Graft (an accessory to a Heartware System)
HeartWare Ltd
- an application by HeartWare Limited for the provision of a conformity assessment certificate for Outflow Graft, provided as an implantable accessory to the Heartware System which is intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure. During the implantation procedure the graft is attached to the outflow cannula of the pump and later attached to the aorta. The graft component provides the conduit for blood to transfer from the outflow cannula of the HeartWare Pump to the aorta.
Mitroflow Aortic Pericardial Heart Valve Model LX
Sorin Group Australia
- an application by Sorin group Australia for the provision of a conformity assessment certificate for the Mitroflow Aortic Pericardial Heart Valve, Model LX sizes 19mm, 21mm, 23mm, 25mm, and 27 mm indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Xenoform Soft Tissue Repair Matrix
Boston Scientific Pty Ltd
- an application by Boston Scientific Pty Ltd for the provision of a conformity assessment certificate for the Xenoform Soft Tissue Repair Matrix indicated for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
Consideration of the activity reports from the ACMD Subcommittees
The 2010/3 ACMD meeting is proposed for 10 September 2010.