Tissue expanders used for post-mastectomy breast reconstruction have remained unchanged since the late 70’s. These conventional saline tissue expanders (TEs) require patients to make regular visits to their surgeon’s office to have a large bolus of saline injected into their expander to inflate it. These trips are time consuming and for many women can be stressful due to additional visits to the surgeon to have a needle inserted into her breast, along with the post-expansion discomfort due to the large saline bolus. These weekly trips add up to months of an unpleasant and disruptive appointment schedule.
The AeroForm® Tissue Expander System is the first significant innovation in TEs in over 40 years. The System is comprised of two primary components: the AeroForm Tissue Expander and the AeroForm Dosage Controller.
The AeroForm Tissue Expander is the first and only TE that utilizes a gas rather than saline for expansion. Each AeroForm Expander contains a small cylinder of compressed CO2 that is released in 10cc increments remotely through instructions from the Dosage Controller.
AeroForm gives patients the opportunity to actively participate in their reconstruction journey by giving them the option to decide when and where to dose. This means fewer office visits, no needles, and minimal discomfort from a low volume daily expansion. The patient and her physician can decide her dosing schedule based on her comfort level and reconstruction plans. And because the patient can dose daily, she may reach her expansion goals in weeks rather than months.1
Patients use the Dosage Controller up to three times a day to gradually inflate the Expander. The Controller is pre-programmed to release only 10cc of gas at a time; there is a 3-hour lockout between doses and a 24-hour lockout after the third dose.
Implantation of the AeroForm Expander is very similar to saline expanders. But unlike it’s saline predecessors, it has an anatomical shape with focused lower pole projection that creates a more naturally-shaped pocket for the permanent implant.
A pivotal, prospective, multicenter, open-label clinical study was performed to compare the safety and efficacy of the AeroForm System to traditional saline expanders in women undergoing breast reconstruction following mastectomy. This study is summarized below:
Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial
Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K.https://www.ncbi.nlm.nih.gov/pubmed/27879582
AeroForm is a new type of remote-controlled, needle-free, carbon dioxide-based expander involving a potentially faster method of tissue expansion. Results are presented here from the AirXpanders Patient Activated Controlled Tissue Expander pivotal trial comparing AeroForm to saline tissue expanders.
Women undergoing two-stage breast reconstruction were randomized at 17 U.S. sites in this U.S. Food and Drug Administration-approved investigational device exemption trial. Expansion in the investigational arm was performed by the patient in 10cc increments up to 30cc/day of carbon dioxide and in the control arm by the physician with periodic bolus injections of saline. Reconstruction success, safety endpoints, expansion and reconstruction times, pain and satisfaction were assessed.
|Mastectomy||Simple||75 (44.6%)||42 (47.7%)|
|Modified Radical||20 (11.9%)||8 (9.1%)|
|Nipple Sparing||59 (35.1%)||33 (37.5%)|
|NA||14 (8.3%)||5 (5.7%)|
|Reconstruction||Unilateral||28 (16.7%)||16 (18.2%)|
|Bilateral||140 (83.3%)||72 (81.8%)|
|Immediate||154 (91.7%)||83 (94.3%)|
|Delayed||14 (8.3%)||5 (5.7%)|
One hundred fifty women were treated: 98 with carbon dioxide expanders (n = 168) and 52 with saline expanders (n = 88). The treatment success rate (all breasts exchanged successfully excluding non-device-related failures) was 96.1 percent for carbon dioxide and 98.8 percent for saline, meeting the study objective of statistical equality for reconstruction success. Median time to full expansion and completion of the second-stage operation was 21.0 and 108.5 days (carbon dioxide) versus 46.0 and 136.5 days (saline), respectively, with a similar rate of overall complications. Ease of use for the carbon dioxide expander was rated high by patients (98 percent) and physicians (90 percent).
The AirXpanders Patient Activated Controlled Tissue Expander trial results demonstrate that a carbon dioxide-based expander is an effective method of tissue expansion with a similar overall adverse event rate compared to saline expanders, and provides a more convenient and expedient expansion.