iVAS Elite balloon system | 合法醫療器材資訊網

...makingittheleastinvasivevertebralaugmentationsystemintheStrykerportfolio....Supportsabilitytoperformvertebralaugmentation/kyphoplastyathigh(er) ...

Warning/adverse events

Serious adverse events, some with fatal outcome, associated with the use of bone cements for vertebroplasty, kyphoplasty and sacroplasty include myocardial infarction, cardiac arrest, cerebrovascular accident, pulmonary embolism and cardiac embolism. Although it is rare, some adverse events have been known to occur up to one year post-operatively. Additional risks exist with the use of bone cement.

Please see Instructions for Use (IFU)[1] for a complete listing of warnings, precautions and adverse events