Medtronic Receives CE Mark For Leading Transcatheter Pulmonary Valve Replacement System For Congenital Heart Disease
Medtronic Receives CE Mark For Leading Transcatheter Pulmonary Valve Replacement System For Congenital Heart Disease
Harmony Transcatheter Pulmonary Valve system approval expands minimally invasive treatment options for patients with congenital heart disease across European Union
Harmony 经导管肺动脉瓣系统的批准扩展了针对欧洲联盟先天性心脏病患者的微创治疗期权。
Medtronic plc, a global leader in healthcare technology, today announced it received CE (Conformité Européenne) Mark for the Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). The Harmony TPV system has already been implanted in over 2,200 patients and now has access to help many more patients across the European Union.
美敦力公司作为全球领先的医疗科技公司，今天宣布其获得了 Harmony 经导管肺动脉瓣 (TPV) 系统的CE（欧洲合规）标志，该系统是面对具有原生或手术修复的右心室流出道 (RVOT) 的先天性心脏病患者的一种微创替代开放心脏手术的选择。Harmony TPV 系统已经在超过2200名患者中植入，现在可以帮助更多的患者，遍及整个欧洲联盟。
The Harmony TPV system is designed to treat patients with RVOT anomalies with severe pulmonary valve regurgitation (PR), a condition where blood leaks back into the right lower chamber of the heart after being pumped into the lungs. Harmony TPV system clinical trials demonstrate ease of implant, conformability to the anatomy, and strong clinical and hemodynamic outcomes for congenital heart disease patients up to three years.
Harmony TPV 系统旨在治疗具有严重肺动脉瓣反流 (PR) 的右心室流出道 anomalies 的患者，这种病症指的是血液在被泵入肺部后又回流到心脏的右下腔。Harmony TPV 系统的临床试验展示了植入的简便性、与解剖结构的适应性以及针对先天性心脏病患者三年内强劲的临床和血流动力学成果。
