Scholarlink

Background <p>Frequently, the breast surgeon must employ complex oncoplastic techniques (OBS) to guarantee optimal cosmetic results. The success of the REGENERA™ implant in combining the benefits of OBS with the simplicity of breast conserving surgery (BCS) has been previously reported in five patients with short follow-up. The goal of this study was to build on these promising data by reporting safety and efficacy results in a larger population with a longer follow-up.</p> Methods <p>Fifteen females with non-malignant breast lesions who underwent lumpectomy and implantation of REGENERA™ device, followed-up for six months, were included in this interventional FIH study. Fourteen of these, were included in a long-term observational study (LTFU) and followed-up for 24 months. Safety (incidence of adverse events [AEs]) and performance (changes in breast appearance, interference with imaging) of the device, and investigator and patient satisfaction were evaluated. Data from these two studies are reported herein. (Registered on clinicaltrials.gov: NCT05533099 and NCT04131972).</p> Results <p>A total of 113 AEs were reported. Only 3 (2.6%) were considered possibly device-related. The great majority (91,2%) were mild/moderate and only in one case the device was explanted. The REGENERA™ implant demonstrated high levels of performance, with an aesthetic score of ‘Excellent’ in 85.7% of patients, no interference with imaging, and high levels of patients and investigator satisfaction.</p> Conclusions <p>Data continue to be strongly supportive of the use of the REGENERA™ implant in BCS, further paving the way for an innovative surgical approach.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Scaffold-based breast conserving surgery in patients with non-malignant breast lesions: long-term follow-up of a first-in-human pilot study on the REGENERA™ biomimetic breast implant

  • 期刊论文

  • 发表日期：

    2025年9月27日

查看全文
  • Maria Donatella Mariniello,
  • Manuela Roncella,
  • Dionisia Mazzotta,
  • Irini Gerges,
  • Livio Colizzi,
  • Margherita Tamplenizza,
  • Alessandro Tocchio,
  • Federico Martello,
  • Maria Ghilardi,
  • Maria Cristina Cossu,
  • Serena Danti,
  • Matteo Ghilli

摘要

Background

Frequently, the breast surgeon must employ complex oncoplastic techniques (OBS) to guarantee optimal cosmetic results. The success of the REGENERA™ implant in combining the benefits of OBS with the simplicity of breast conserving surgery (BCS) has been previously reported in five patients with short follow-up. The goal of this study was to build on these promising data by reporting safety and efficacy results in a larger population with a longer follow-up.

Methods

Fifteen females with non-malignant breast lesions who underwent lumpectomy and implantation of REGENERA™ device, followed-up for six months, were included in this interventional FIH study. Fourteen of these, were included in a long-term observational study (LTFU) and followed-up for 24 months. Safety (incidence of adverse events [AEs]) and performance (changes in breast appearance, interference with imaging) of the device, and investigator and patient satisfaction were evaluated. Data from these two studies are reported herein. (Registered on clinicaltrials.gov: NCT05533099 and NCT04131972).

Results

A total of 113 AEs were reported. Only 3 (2.6%) were considered possibly device-related. The great majority (91,2%) were mild/moderate and only in one case the device was explanted. The REGENERA™ implant demonstrated high levels of performance, with an aesthetic score of ‘Excellent’ in 85.7% of patients, no interference with imaging, and high levels of patients and investigator satisfaction.

Conclusions

Data continue to be strongly supportive of the use of the REGENERA™ implant in BCS, further paving the way for an innovative surgical approach.