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04-18-2015, 02:54 AM
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AirXpanders Completes Enrollment in XPAND US Pivotal Trial
AirXpanders Completes Enrollment in XPAND US Pivotal Trial
AirXpanders Inc., a company developing **vel tech**logy for women who require tissue expansion for breast reconstruction following a mastectomy, today an**unced that it has completed the targeted Enrollment of 150 subjects in the company’s U.S.-based, multi-center, prospective, randomized, controlled, open-label Pivotal study of the AeroForm® patient-controlled tissue expander. The XPAND study was designed to directly compare outcomes in two-stage breast reconstruction – including successful expansion to implant exchange, average number of days to achieve the desired expansion, total reconstruction time, pain and patient satisfaction – with AeroForm versus traditional saline expanders. The traditional method for tissue expansion requires women to visit their physician for frequent injections of saline until they complete the process, which can take up to six months as reported in the literature. “Today, only around 30-40 percent of women who have had a mastectomy undergo reconstruction, as many women are **t aware of their reconstruction options. Some candidates for reconstructive surgery say that the reported long and sometimes painful saline-based expansion process kept them from pursuing that option,” said XPAND Principal Investigator Jeffrey Ascherman, M.D., FACS, site chief of the Division of Plastic Surgery at New York-Presbyterian Hospital/Columbia University Medical Center. “Eliminating some of the ****** visits required to inflate saline expanders by needle injections is a definite advantage of the new expander over the traditional process. My patients have also appreciated the opportunity to play an active role in recovering their bodies after breast cancer surgery.” In an interim preliminary review of study data, as reported in the May 2014 edition of the Annals of Plastic Surgery, Kamakshi Zeidler, M.D., FACS at Good Samaritan Hospital in San Jose, California reported that 115 patients were enrolled in the XPAND study and randomized to either the AeroForm or saline group. The group who received the AeroForm patient-controlled expanders completed expansion in an average of 17 days, compared with the saline group whose expansion process extended an average of 52 days (P ??????? ??????: AirXpanders Completes Enrollment in XPAND US Pivotal Trial || ??????: rss || ??????: اسم منتداك
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