Objectives: The lecture will show a new medical devices that is unique and helps to overcome the Problem with female adrogenic alopecia.
Under the very strict new CE rules this hair implant gots ist certification as medical device.
We will show how to use and how to manage it.
Introduction: The HairsteticsTM hair implant device is a novel comprehensive alopecia solution. The product has been approved in Israel, Brazil, New Zealand, Switzerland, EU and Thailand. Till now it has been applied for the treatment of 140 patients. The relative scarcity of treatment options for alopecia, in general, is obfuscated by the serious side effects of some pharmaceuticals that are specific to their use in female patients, especially during pregnancy. Applicability of the surgical approach, i.e. hair transplantation, is subject to the status of donor hair population and is disparaged in cases of
Materials / method: This was a prospective, single-arm, multi-centre, international, open-label, non-randomized clinical study recruiting in Europe (France, Romania and UK) and India, in compliance with the applicable rules and regulations. The study population consisted of male and female subjects, 19 years of age or older, who are diagnosed with hair loss (alopecia) and that can and wish to be treated by synthetic hair implantation. The primary endpoints were number, duration and severity of expected adverse device/procedure effects during three months after the implantation. The secondary endpoints were subjec
Results: All of the device/procedure-related adverse events reported appear to be mild to moderate, thus lending support to the safety findings reported in the Hairstetics™ hair implant device first-in-man study. There were no occurrences of device/procedure-related serious adverse events or device deficiencies that could have led to such. Subjects undergoing full implantation indicated their satisfaction with the procedure outcome. Even in the worst scenario analysis, 91% of such subjects graded their satisfaction with the aesthetic status six months after the procedure higher than prior to it. In gen
Conclusion: In view of the reported results of the clinical studies the HairsteticsTM hair implant device continues to show a promising safety profile. Together with overall durable satisfaction of the implanted subjects with the procedural outcome, the benefits expected to be associated with use of the Hairstetics appear to outweigh the anticipated risks. The Bochum (Germany) Group will serve as Research Center für this field in futire (www.hautteam.de)
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