Xpand is a prospective, randomized, controlled, open-pivot Aeroform ™ community breast tissue expansion device in patients undergoing a mastectomy, breast reconstruction.
The first patient who received the device was implanted Aeroform in New York on November 30. Another three patients were enrolled in the trial and awaiting processing.
"Taking into account the data collected in the feasibility trial of PACE was recently released, the device has the potential to offer patients Aeroform breast cancer process of free needles and more comfortable with the expansion of tissue in the breast reconstruction after mastectomy," said Leroy Young, MD , FACS, St. Louis Breast Cancer Charity and the Institute, principal investigator for the court XPAND. "This study will compare patient-controlled, carbon dioxide Aeroform device based on a standard method of saline injection, often difficult process, which has historically been an important factor decide against breast reconstruction for many women. "
The process of enlargement of tissue is often necessary after a mastectomy, to stretch the skin and muscles of the chest wall, so that the permanent breast implants can be inserted. Traditionally, surgeons implanted a tissue expander under the skin, salt and pectoral muscles in place a mastectomy. During subsequent visits to the office a week, surgeon inserts a needle through the skin into the fabric of the port expansion and give as much salt as a temporary implant in a woman can endure.
AirXpanders Aeroform tissue expander is designed to address the limitations of traditional salt extenders. The system consists of self-tissue expander technologically advanced and handle wireless remote control. Aeroform system eliminates the need for invasive injections of saline solution using compressed carbon dioxide that is released slowly through a small inner valve for filling the expander. Following the standard procedure for implantation, the patient can use the remote control at home to complete the expansion process, as prescribed by your doctor.
"This important event for the company as we begin to collect data that will be submitted to FDA in support of our 510 (k) statement," said Scott Dodson, President and Chief AirXpanders control. "Every year 250 000 women who underwent mastectomy, and for those who choose reconstruction, we believe that accountability will Aeroform that will allow these patients to move their lives, have more control in the process of expanding tissues and have the potential to avoid destructive visits to the doctor every week. "
At trial, the company's capabilities in Australia, while the expansion of tissue due to the expansion of remote Aeroform was 15 days, the percentage of time required by conventional salt extenders.
The test is designed to directly compare the results of the method of tissue expansion to expand the traditional investigation Aeroform salt, remotely controlled, a tissue expander without a needle. Registration will continue until a total of 92 aircraft and 46 Aeroform saline expanders were implanted in patients.
V. Food and Drug Administration (FDA) granted the company experienced Exemption devices (IDE) to conduct clinical trials. Participation sites include hospitals, Boston, New York, St. Louis, San Diego, Sacramento, San Jose, and Durham, North Carolina.
The first patient who received the device was implanted Aeroform in New York on November 30. Another three patients were enrolled in the trial and awaiting processing.
"Taking into account the data collected in the feasibility trial of PACE was recently released, the device has the potential to offer patients Aeroform breast cancer process of free needles and more comfortable with the expansion of tissue in the breast reconstruction after mastectomy," said Leroy Young, MD , FACS, St. Louis Breast Cancer Charity and the Institute, principal investigator for the court XPAND. "This study will compare patient-controlled, carbon dioxide Aeroform device based on a standard method of saline injection, often difficult process, which has historically been an important factor decide against breast reconstruction for many women. "
The process of enlargement of tissue is often necessary after a mastectomy, to stretch the skin and muscles of the chest wall, so that the permanent breast implants can be inserted. Traditionally, surgeons implanted a tissue expander under the skin, salt and pectoral muscles in place a mastectomy. During subsequent visits to the office a week, surgeon inserts a needle through the skin into the fabric of the port expansion and give as much salt as a temporary implant in a woman can endure.
AirXpanders Aeroform tissue expander is designed to address the limitations of traditional salt extenders. The system consists of self-tissue expander technologically advanced and handle wireless remote control. Aeroform system eliminates the need for invasive injections of saline solution using compressed carbon dioxide that is released slowly through a small inner valve for filling the expander. Following the standard procedure for implantation, the patient can use the remote control at home to complete the expansion process, as prescribed by your doctor.
"This important event for the company as we begin to collect data that will be submitted to FDA in support of our 510 (k) statement," said Scott Dodson, President and Chief AirXpanders control. "Every year 250 000 women who underwent mastectomy, and for those who choose reconstruction, we believe that accountability will Aeroform that will allow these patients to move their lives, have more control in the process of expanding tissues and have the potential to avoid destructive visits to the doctor every week. "
At trial, the company's capabilities in Australia, while the expansion of tissue due to the expansion of remote Aeroform was 15 days, the percentage of time required by conventional salt extenders.
The test is designed to directly compare the results of the method of tissue expansion to expand the traditional investigation Aeroform salt, remotely controlled, a tissue expander without a needle. Registration will continue until a total of 92 aircraft and 46 Aeroform saline expanders were implanted in patients.
V. Food and Drug Administration (FDA) granted the company experienced Exemption devices (IDE) to conduct clinical trials. Participation sites include hospitals, Boston, New York, St. Louis, San Diego, Sacramento, San Jose, and Durham, North Carolina.
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