FemPulse announced today that it received FDA investigational device exemption(IDE)approval for its overactive bladder(OAB)therapy.
FemPulse今天宣布其膀胱過度活動癥（OAB）療法獲得了美國食品及藥物管理局（FDA）的研究設備豁免（IDE）批準。
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.
該公司現在可以開始對患有OAB的女性患者進行EVANESCE II關鍵性臨床試驗。其FemPulse系統已進入歐盟MDR程序的最后階段，以獲得該地區的監管批準。公司希望2025年能在歐洲上市，并有可能在美國獲得批準。
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.
公司創始人兼首席醫療官亞歷山德拉-海斯勒（Alexandra Haessler）博士創造了陰道插入式可拆卸FemPulse Ring。她在一份新聞稿中說，這是一種“內部可穿戴設備”，無需手術即可提供持續的OAB神經調節治療。
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.
據海斯勒稱，這種隱蔽的、由患者管理的環具有“設置好就不用管它”的特點。該公司計劃通過與藥物治療隨機對比的試驗，確認該戒指是藥物治療的一線替代品。海斯勒說，公司希望解決藥物療效有限和副作用難以忍受導致患者停藥的問題。
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.”
蘇澤特-薩瑟蘭博士是FemPulse Ring前兩次成功臨床試驗的主要研究者。她還擔任華盛頓大學女性泌尿科主任一職。薩瑟蘭說：“我在患者身上使用FemPulse環的親身體驗和臨床試驗結果證實了我對FemPulse可穿戴療法的堅定信念。我很高興能在這項多中心IDE試驗中為FemPulse提供支持，并期待著再次在國際會議上分享試驗結果。
