FemPulse announced today that it received FDA investigational device exemption(IDE)approval for its overactive bladder(OAB)therapy.
FemPulse今天宣布其膀胱过度活动症（OAB）疗法获得了美国食品及药物管理局（FDA）的研究设备豁免（IDE）批准。
The company can now begin the EVANESCE II pivotal clinical trial in female patients suffering from OAB.Its FemPulse system is already at the final stage of the EU MDR process for regulatory approval in that region.The company hopes for commercial availablility in Europe in 2025 and potentially U.S.approval down the line.
该公司现在可以开始对患有OAB的女性患者进行EVANESCE II关键性临床试验。其FemPulse系统已进入欧盟MDR程序的最后阶段，以获得该地区的监管批准。公司希望2025年能在欧洲上市，并有可能在美国获得批准。
Dr.Alexandra Haessler,the company’s founder and chief medical officer,created the vaginally-inserted,removable FemPulse Ring.It’s an“internal wearable,”she said in a news release,providing continuous OAB neuromodulation therapy without requiring surgery.
公司创始人兼首席医疗官亚历山德拉-海斯勒（Alexandra Haessler）博士创造了阴道插入式可拆卸FemPulse Ring。她在一份新闻稿中说，这是一种“内部可穿戴设备”，无需手术即可提供持续的OAB神经调节治疗。
According to Haessler,the discreet,patient-managed ring features a“set it and forget it”approach.The company plans for its trial—randomized against medication—to confirm the ring as a first-line alternative to medications.Haessler said the company wants to address the limited efficacy and intolerable side effects of medications that cause patients to discontinue use.
据海斯勒称，这种隐蔽的、由患者管理的环具有“设置好就不用管它”的特点。该公司计划通过与药物治疗随机对比的试验，确认该戒指是药物治疗的一线替代品。海斯勒说，公司希望解决药物疗效有限和副作用难以忍受导致患者停药的问题。
Dr.Suzette Sutherland served as the principal investigator on two previous successful clinical trials of the FemPulse Ring.She also holds the post of director of female urology at the University of Washington.Sutherland said:“My hands-on experience using the FemPulse Ring with patients and the clinical trial results confirmed my strong belief in FemPulse’s wearable therapy.I am thrilled to support FemPulse in this multi-center IDE trial and look forward to once again sharing the results at international conferences.”
苏泽特-萨瑟兰博士是FemPulse Ring前两次成功临床试验的主要研究者。她还担任华盛顿大学女性泌尿科主任一职。萨瑟兰说：“我在患者身上使用FemPulse环的亲身体验和临床试验结果证实了我对FemPulse可穿戴疗法的坚定信念。我很高兴能在这项多中心IDE试验中为FemPulse提供支持，并期待着再次在国际会议上分享试验结果。