UNASSIGNED: The MiTR system was evaluated in 7 acute and 2 chronic porcine (7-day) models to evaluate the efficacy of tissue excision with bipolar RF sealing of blood vessels and airways and application of an autologous blood patch into the excised tissue cavity. Air leak was recorded for all evaluations. The study was approved by the institutional ethical board.
UNASSIGNED: Nineteen lung tissue samples, measuring 2.5 cm long × 1.2 cm diameter, were excised. In 8 of 9 animals (89%), hemostasis and pneumostasis were observed visually at the completion of the procedure. In 2 of 2 chronic animals (100%), hemostasis and pneumostasis persisted for the 7-day observation period. Histologic examination of the excised samples showed preservation of the core parenchymal architecture without evident tissue damage of the samples that would impair pathologic analysis.
UNASSIGNED: Percutaneous resection of targeted lung tissue with the MiTR system demonstrated hemostasis and pneumostasis while obtaining a histologically intact sample. After regulatory approval, the use of this device could offer more tissue for analysis than a transthoracic needle biopsy or bronchoscopy and a far less invasive alternative to video-assisted thoracic surgery or thoracotomy. This may also expand patient and physician options for the early diagnosis and treatment of lung cancer.
■在7种急性和2种慢性猪(7天)模型中评估了MiTR系统,以评估通过双极RF密封血管和气道以及将自体血贴片应用于切除的组织腔中的组织切除的功效。记录所有评价的漏气情况。这项研究得到了机构伦理委员会的批准。
■19个肺组织样本,长2.5厘米×直径1.2厘米,被切除了。9只动物中有8只(89%)在手术完成时目测观察到止血和气滞.2只慢性动物中有2只(100%)止血和气滞持续7天的观察期。切除样品的组织学检查显示,保留了核心实质结构,而没有明显的损害病理分析的样品组织损伤。
■用MiTR系统经皮切除靶肺组织显示止血和气滞,同时获得组织学上完整的样品。经监管部门批准后,与经胸穿刺活检或支气管镜检查相比,该装置的使用可以提供更多的组织分析,并且是电视胸腔镜手术或开胸手术的侵入性要小得多的替代方案.这也可以扩展患者和医生对肺癌的早期诊断和治疗的选择。