EN
登录

Magenta Medical在美国对世界上最小、最强大的心脏泵的早期可行性研究结果将在TCT 2023美国-英语-以色列-英语

Results from Magenta Medical's US Early Feasibility Study of the World's Smallest and Most Powerful Heart Pump to be Highlighted at TCT 2023

CISION 等信源发布 2023-10-10 18:58

可切换为仅中文


Study data will be featured in an oral presentation delivered by Dr. Samin K. Sharma, Director of Interventional Cardiology, Mount Sinai HospitalKADIMA, Israel , Oct. 10, 2023 /PRNewswire/ --Results from Magenta Medical's Early Feasibility Study of the Elevate™ System, for the high-risk percutaneous coronary intervention (HR-PCI) indication, will be announced in an oral presentation at the Transcatheter Cardiovascular Therapeutics (TCT) conference, the annual scientific symposium of the Cardiovascular Research Foundation in San Francisco.

研究数据将在以色列西奈山医院介入心脏病学主任Samin K.Sharma博士于2023年10月10日/PRNewswire/-洋红色医疗早期可行性研究的成果中发表™ 用于高风险经皮冠状动脉介入治疗(HR-PCI)适应症的系统将在旧金山心血管研究基金会年度科学研讨会经导管心血管治疗(TCT)会议上的口头报告中宣布。

Elevate™ is the world's smallest and most powerful percutaneous Left Ventricular Assist Device (pLVAD)..

提升™ 是世界上最小和最强大的经皮左心室辅助装置(pLVAD)。。

Continue Reading

继续阅读

Image of the Magenta Elevate™ Pump, the smallest and most powerful pLVAD.

洋红色升高的图像™ 泵,最小和最强大的pLVAD。

The presentation will be delivered by Dr. Samin K. Sharma, the Director of Interventional Cardiology at the Mount Sinai Hospital and the first to perform a HR-PCI procedure with Elevate™ in the US.

演示文稿将由西奈山医院介入心脏病学主任Samin K.Sharma博士提供,并首次采用Elevate进行HR-PCI手术™ 在美国。

Presentation title: Magenta Elevate™: First US Experience with High-Output, Low-French Size Percutaneous Mechanical Circulatory Support

演示标题:洋红色提升™: 美国首创高输出,低法国尺寸经皮机械循环支持的经验

Date and time: Wednesday, October 25, 2023, at 9:19 a.m. Pacific Daylight Time.Session: TCT Innovation V: Innovation in Coronary Disease Diagnosis and Therapies/Featured Technological Trends: Percutaneous Mechanical Circulatory Support.Location: Innovation & Clinical Science Theater, Hall B, Exhibition Level, Moscone South, Moscone Center.Dr.

日期和时间:2023年10月25日星期三,上午9:19太平洋白天时间。会议:TCT创新V:冠心病诊断和治疗创新/特色技术趋势:经皮机械循环支持。地点:创新与临床科学剧院,B厅,展览级别,Moscone South,Moscone Center.Dr。

Sharma said, 'I was excited to see this abstract accepted for presentation, since this is the first US study to evaluate a novel pLVAD for some years. I look forward to sharing the detailed clinical and hemodynamic data with my colleagues in support of the three cardinal features of the Elevate™ pLVAD – small insertion profile, high pump flow, and ease-of-use.'Magenta's US Early Feasibility Study was initiated to evaluate the safety and feasibility of the Elevate™ System in providing temporary mechanical circulatory support during HR-PCI procedures.

Sharma说:“我很高兴看到这个摘要被接受发表,因为这是美国第一个评估新型pLVAD多年的研究。我期待与我的同事分享详细的临床和血液动力学数据,以支持Elevate的三个基本特征™ pLVAD–插入曲线小,泵流量高且易于使用。”Magenta的美国早期可行性研究旨在评估Elevate的安全性和可行性™ 系统在HR-PCI过程中提供临时机械循环支持。

Fifteen patients were treated in the study at the Mount Sinai Hospital, St. Francis Hospital and Heart Center, and North Shore University Hospital.About Elevate™The Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) is a miniaturized heart pump that fits an 8 Fr delivery system. The ElevateTM Pump can be inserted over a guidewire, using a 10 Fr commercially available femoral introducer sheath, providing the smallest crimping profile in the industry.

在西奈山医院,圣弗朗西斯医院和心脏中心以及北岸大学医院对15名患者进行了研究™提升™ 经皮左心室辅助装置(pLVAD)是一种小型心脏泵,适合8-Fr输送系统。ElevateTM泵可以使用10-Fr市售股骨导引鞘插入导丝上,在工业中提供最小的卷曲轮廓。

The flow of the pump is adjusted based on the clinical circumstances of the patient and can exceed 5 L/min of mean flow. This makes it the most powerful device of its kind.Elevate™ is an investigational device, limited by federal law to investigational use only. The technology was awarded Breakthrough Device Designation from the US Food and Drug Administration (FDA) for two indications: high-risk percutaneous coronary intervention .

根据患者的临床情况调整泵的流量,并且可以超过5L/min的平均流量。这使其成为同类产品中功能最强大的设备。提升™ 是一种研究设备,仅限于联邦法律的研究用途。该技术获得了美国食品和药物管理局(FDA)的突破性设备指定,用于两种适应症:高风险经皮冠状动脉介入治疗。