Colospan announced today that it won FDA investigational device exemption for its CG-100 temporary intraluminal bypass device for gastrointestinal resection procedures.
Following the IDE win, Israel-based Colospan plans to launch its pivotal study for the CG-100 device, which is designed to reduce diverting stoma rates in patients undergoing those resection procedures.
In comparison to diverting stoma that is usually deployed for four-to-six months and requires a second surgery for removal, the CG-100 is meant to be deployed for just 10 days and includes easy removal under X-ray without the need for a second surgery, according to a news release.
Colospan intends to launch its prospective, randomized pivotal study in the first quarter of 2020. It is slated to be conducted across the U.S. and Europe to support future regulatory approval efforts in the U.S.
“We are pleased to have received FDA approval of our IDE application and we look forward to initiating the pivotal study which is a leap forward towards bringing our novel device closer to the market,” Colospan CEO Boaz Assaf said in the news release. “The pivotal study will allow us to assess the potential of our device to improve patients’ lives, significantly reduce healthcare costs and as a result empower physicians to deliver an improved standard of care. This is a significant milestone for our company as we advance the clinical development of our novel technology in the U.S.”
Colospan 公司今天宣布，其 CG-100用于胃肠道切除的临时旁路装置获得 FDA 的研究设备豁免。
在 IDE 获胜后，总部位于以色列的 Colospan 计划启动其 CG-100设备的关键研究，该设备旨在降低接受这些切除手术的患者的口腔憩频率。
据一份新闻稿称，与通常配置4至6个月、需要进行第二次手术切除的造口术相比， CG-100计划仅部署10天，包括在不需要第二次手术的情况下使用 X 射线进行简单切除。
Colosspan 首席执行官 Boaz Assaf 在新闻稿中表示：“我们很高兴收到 FDA 对我们 IDE 应用程序的批准，我们期待着启动这一关键研究，这是我们将新设备推向市场的一个飞跃。”“关键研究将使我们能够评估我们设备的潜力，以改善患者的生活，显著降低医疗成本，从而使医生能够提供更好的护理标准。这是我们公司在美国推进新技术临床开发的一个重要里程碑。”