Surgical planning/navigation-enhancement system

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Saatavilla:

BresMedical Pty Ltd

luokka:

Class I

Valmistaja:

BresMedical Pty Ltd 45 Lancaster Street, Ingleburn, NSW, 2565 Australia

Terapeuttinen alue:

61496 - Surgical planning/navigation-enhancement system

Käyttöaiheet:

The ImplaNav system is an integrated software-hardware solution able to track in real time the position of a dental drill tip in action and to create its dynamic representation over a surgical virtual planning based on a tomographic scan. The ImplaNav system aims to reduce the risks and improve the outcome of the operation as an additional verification and monitoring instrument supplementary to the equipment already used by the practitioner on a routine basis. More specifically, the ImplaNav software allows a surgical planning through the virtual insertion or implants in a multi-view interface. In its navigation function the system aims to give an indicative status of the surgical drill during the surgical procedure with respect to the virtual planning. The system can also be used for educational purposes. In practice, the ImplaNav navigation and dental drill guide automatic design technology can be applied to plastic or bone-like phantoms in order to simulate or reproduce a surgical procedure into a context such as a surgical skills laboratory. The ImplaNav system should only be used during surgery by oral surgeons, dentists, orthodontists, maxillofacial surgeons while it can be used by students and other professionals for training purposes on anatomical replicas instead of real patients. The system is only meant to be used with the reference set of instruments provided by the manufacturer as part of the ImplaNav system. The ImplaNav system does not aim to replace conventional surgical procedures in oral and maxillo-facial implant placement. Any use of the system which is not merely additional guidance in implant placement is considered a misuse.

Valtuutuksen tilan:

A

Valtuutus päivämäärä:

2015-09-18