Loading...Loading...On Friday, Medtronic plc MDT released results from the SPHERE Per-AF study comparing Sphere-9 to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.The findings were presented as late-breaking clinical data at the Heart Rhythm Society 2024 Annual Meeting and published in Nature Medicine.  The study demonstrated the safety and efficacy of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter for persistent atrial fibrillation (AFib). Atrial fibrillation (AFib) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure, and other heart-related complications. Related: Medtronic’s Latest Generation Of Transcatheter Aortic Valve Replacement Implant Passes FDA’s Muster, Shares Gain.AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.The Sphere-9 Catheter demonstrated a favorable safety profile with a primary safety endpoint rate of 1.4% (1.0% for the control arm). No safety events were reported, including pulmonary vein stenosis, esophageal events, or cardiac tamponade. More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.Sphere-9 demonstrated 73.8% freedom from AFib vs.

正在加载。。。正在加载。。。周五，美敦力plc MDT发布了SPHERE Per AF研究的结果，将SPHERE-9与传统的Thermocool SmartTouch SF射频消融导管与Carto 3系统进行了比较。这些发现在2024年心律学会年会上作为最新的临床数据发表在《自然医学》上。该研究证明了使用Sphere-9导管，多功能脉冲场（PF）和射频（RF）消融以及高密度（HD）标测导管的Affera标测和消融系统治疗持续性心房颤动（AFib）的安全性和有效性。心房颤动（AFib）是一种颤动或不规则的心跳（心律失常），可导致血栓，中风，心力衰竭和其他与心脏相关的并发症。相关报道：美敦力最新一代经导管主动脉瓣置换植入物通过FDA的审查，分享收益。AFib是最常见且治疗不足的心律失常之一，影响全球6000多万人。Sphere-9导管表现出良好的安全性，主要安全终点率为1.4%（对照组为1.0%）。没有报告安全事件，包括肺静脉狭窄，食管事件或心脏压塞。超过95%的Sphere-9手术使用单次经腹穿刺，而对照组为62%。Sphere-9显示出73.8%的AFib自由度。

only 65.8% observed in the control arm. Following 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 Catheter also observed less recurrence of atrial arrhythmias throughout the 12-month follow-up period.Treatment with the Sphere-9 catheter demonstrated superior efficiency over the control arm for procedural characteristics, in.

在对照组中仅观察到65.8%。在100%急性隔离肺静脉和线性病变后，用Sphere-9导管治疗的患者在整个12个月的随访期间也观察到房性心律失常的复发较少。Sphere-9导管治疗在手术特征方面显示出优于对照组的效率。

Skin-to-skin procedural time.

皮肤到皮肤的程序时间。

The time between the first and last ablation.

第一次和最后一次消融之间的时间。

Energy application time.

能源应用时间。

Patients treated with the Sphere-9 catheter experienced improvements in quality of life.Read Next: Medtronic Recalls Neurosurgery Catheter Tubing, FDA Identifies As Serious Recall.Price Action: MDT shares are down 1.45% at $84.67 at last check Monday.Photo by Tony Webster via Wikimedia CommonsLoading...Loading...Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com.

用Sphere-9导管治疗的患者生活质量有所改善。接下来阅读：美敦力召回神经外科导管，FDA认定为严重召回。价格走势：周一最后一次检查显示，MDT股价下跌1.45%，至84.67美元。托尼·韦伯斯特（TonyWebster）通过Wikimedia CommonLoading拍摄的照片。。。正在加载。。。Benzinga API为您带来的市场新闻和数据©2024 Benzinga.com。

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