Medtronic plc has announced the initiation of the U.S. expansion of the Global SYMPLICITY Registry $(GSR.AU)$ DEFINE clinical trial. This study is focused on documenting the safety and effectiveness of the Symplicity™ Spyral renal denervation $(RDN)$ system in a real-world setting for patients with uncontrolled hypertension. The first U.S. procedure was conducted by Dr. Stan Thornton at Thomas Hospital in Fairhope, Alabama. The GSR-DEFINE trial is an extension of the existing Global SYMPLICITY Registry and aims to enhance understanding of renal denervation's impact on U.S. patients. The trial is a prospective observational study involving 251 sites across 55 countries, with a total of 5,000 patients globally. The Symplicity Spyral RDN system has shown promising results in previous studies, including a three-year decline in office systolic blood pressure of 16.3 mm Hg in evaluated patients outside the U.S. The results of the GSR-DEFINE trial will be documented in the future as the study progresses. The Symplicity RDN system is currently approved for commercial use in over 75 countries.
免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。