2023年5月10日

分享這篇文章分享本文魁北克市,5月10日2023 /時間/ - OpSens Inc . (“OpSens”或“公司”)(TSX:行動)(OTCQX: OPSSF),醫療設備cardiology-focused公司提供創新的解決方案基於其專有的光學技術,高興地宣布SavvyWire納入完整的TAVR臨床研究探討標準化入侵血流動力學的影響(矽)在經導管主動脈瓣置換術或TAVR程序。完成TAVR,愛德華生命科學公司"讚助的研究者發起的一項研究,將決定完成血管再生的策略涉及了經皮冠狀動脈介入(PCI)使用藥物洗脫支架治療所有合適的冠狀動脈病變氣球充氣TAVR成功之後,優於單獨藥物治療的策略在降低心血管死亡的綜合結果,新的心肌梗死,ischemia-driven血管再生或住院治療不穩定性心絞痛或心力衰竭。完整的TAVR研究是一項隨機、多中心、非盲試驗盲判決的結果與計劃招生4000名患者高達120的中心。的矽氮亞使用SavvyWire將招收200名患者,20中心橫跨美國和加拿大。“我們期待的結果完成TAVR標準化入侵血流動力學研究中,在SavvyWire有可能簡化的急性和長期的血流動力學評估病人post-TAVR,”大衛·伍德博士說,導演,哥倫比亞大學心血管中心創新和全球完成TAVR研究的首席研究員。的矽氮亞使用SavvyWire已經開始招生,並預計在2023年晚些時候完成,結果在2024年初預期。伍德博士將提供更新的進展研究更多的數據可用。SavvyWire不僅僅是一個線,作為世界第一,隻有sensor-guided TAVR解決方案。它獨特的提供了一個穩定的主動脈瓣3-in-1解決方案交付和定位,連續準確的血流動力學測量過程期間,和可靠的左心室踱步而不需要輔助設備或靜脈訪問。關於完成TAVR (https://www.clinicaltrials.gov/ct2/show/NCT04634240) OpSens主要關注心髒病。 The Company offers an advanced optical-based pressure guidewire that aims at improving the clinical outcome of patients with coronary artery disease. Its flagship product, the OptoWire, is a second-generation fiber optic pressure guidewire designed to provide the lowest drift in the industry and excellent lesions access. The OptoWire has been used in the diagnosis and treatment of more than 200,000 patients in more than 30 countries. It is approved for sale in the United States, the European Union, the United Kingdom, Japan and Canada. OpSens has recently received FDA clearance and Health Canada approval to commercialize the SavvyWire for transcatheter aortic valve replacement procedures (TAVR). This unique guidewire is a 3-in-1 solution for stable aortic valve delivery and positioning, continuous accurate hemodynamic measurement during the procedure, and reliable left ventricular pacing without the need for adjunct devices or venous access. OpSens' SavvyWire is on trend with a minimalist approach to TAVR and advances the procedure, allowing patients to leave the hospital earlier, sometimes the same day. The TAVR procedure is growing rapidly globally, driven by the aging population and recent studies that demonstrate its benefits for a broader array of patients. The global TAVR market is currently estimated at over 200,000 procedures and is expected to reach 400,000 in 2027. OpSens is also involved in industrial activities in developing, manufacturing, and installing innovative fiber optic sensing solutions for critical applications. SOURCE OpSens Inc. For further information: Louis Laflamme, CPA, President and Chief Executive Officer, 418.781.0333; John Hannigan, FCA, Chief Financial Officer, 418.781.0333 ×