General AeroForm® Questions
AeroForm® has been granted regulatory approval in Europe and Australia.
In the US, AirXpanders® has completed its FDA-approved pivotal trial. AeroForm is currently under review by the FDA.
Ideal candidates for AeroForm® are women who have had a mastectomy and require tissue expansion as part of their breast reconstruction process.
Yes. We are currently investigating the use of the AeroForm® in burn patients and patients who suffer from severe disfigurement as a result of an accident or birth defect.
Yes. Following a mastectomy, the decision to pursue breast reconstruction surgery is a very personal choice. The aim of the AeroForm® tissue expander is to offer a needle-free, patient-controlled solution for those debating their breast reconstruction options following a mastectomy, whether immediately or some years later. Currently the device is not yet available to patients in the US.
It is expected that AeroForm® will be covered under existing US Medicare codes. Reimbursement coverage for reconstructive breast procedures by both US Medicare and private insurers is mandated in the US under the Women’s Healthcare Act of 1998 (US).
The AeroForm® is reimbursed in Australia through the Private Health Insurance Prostheses List, which provides rebates for the cost of approved implantable medical devices used in certain surgical procedures that are performed in private hospitals.
If you have private health insurance with hospital coverage, there should be no out-of-pocket expenses for the AeroForm®, although there may be other out-of-pocket costs associated with your surgery. Speak with your physician and your private health insurer for more information on costs as they relate to your specific situation.
If you do not have private health insurance, speak to your physician about the availability of the AeroForm® in the public hospital in which you will have your reconstructive procedure.
We’ve made it as simple as possible for you to use your AeroForm® device in the comfort of your own home. AeroForm® is designed to administer a maximum of three doses per day, at a minimum interval of three hours between each dose. Once you have located your device with the wireless dose controller, a central green light and a steady tone will indicate dosing is in progress. A flash of green lights and a musical tone will indicate when dosing is complete. After dosing, your controller will switch off.
Yes, You will be able to deliver three 10cc doses per day, with a 3 hour lock out between doses, until the tissue expander has reached its target volume.
Every patient is unique in their recovery process. In a recently published clinical trial, AeroForm® patients achieved full tissue expansion within a few weeks. This may make it possible for the patient to schedule and complete their breast reconstruction much sooner than under the traditional saline expansion process.
Data published to date from AirXpanders®’ U.S. and Australian-based clinical studies has demonstrated a statistically significant reduction in expansion time for women using AeroForm® compared to women undergoing traditional saline expansion. Patients in the studies completed expansion within an average of 17 days, as compared to three to six months for saline expanders.
Once the device reaches full volume, it will not allow you to continue daily dosing.
If you are a patient with the AeroForm device currently implanted and you have specific questions on how to use your dose controller, how to dose or any other questions relating to your device, please refer to your Patient Home Instructions booklet and/or contact your physician.
Please consult with your physician to determine when your individual expansion has been completed and you have healed enough to receive permanent implants.