Medtronic Gets FDA Nod for IN.PACT AV for ESRD Patients

美敦力新版药物涂层球囊IN.PACT AV获得美国FDA批准

2019-11-27 14:00:53 YAHOO!FINANCE


Medtronic plc MDT announced that it received the FDA clearance for IN.PACT AV drug-coated balloon to treat failing arteriovenous access in patients with end-stage renal disease currently undergoing dialysis. The IN.PACT AV DCB is a paclitaxel-coated balloon, which will be used for the treatment.Patients with ESRD undergo surgeries to create AV fistulae to enable hemodialysis. However, over time the fistulae fail to provide the required access due to vessel restenosis . To prevent this, Medtronic had been working to bring the technology to surgeons in the United States to help improve the lives of ESRD patients.The recent approval is expected to strengthen the company’s foothold in the global hemodialysis market and expand its offerings of DCB. A Peek Into the StudyThe FDA approval is based on data from a prospective, global, multicenter, blinded, randomized (1:1), investigational device exemption (“IDE”) study. The study evaluated the safety and effectiveness of the IN.PACT AV DCB on the enrolled patients at 29 sites in the United States, Japan and New Zealand.The primary end-point of proving the superiority of IN.PACT AV DCB compared to percutaneous transluminal angioplasty (“PTA”) was met by the early data presented at the Cardiovascular Interventional Radiological Society of Europe (“CIRSE”). Further, the data presented at VIVA 2019 stressed on the superior patency of the DCB, with respect to both de novo and restenotic lesions, and all studied types of AV access.Why is the Approval Significant?ESRD patients have to undergo maintenance surgeries every year to restore the functioning of the fistula lesions created for hemodialysis, which result in disruptions to critical hemodialysis care and increased healthcare costs. Pivotal randomized results from the IN.PACT AV Access trial proved that it can extend the gap between the reintervention surgeries, thereby maximizing a patient’s uninterrupted access to dialysis care.Per the company, no treatment was available for AV fistulae lesions, with the ability to maintain primary patency and reduce reinterventions over time until recently. Medtronic believes that the FDA approval will allow it to expand the IN.PACT DCB platform. The company also plans to leverage the technology of its IN.PACT Admiral platform for the same.Notably, in 2016, the CE Mark for IN.PACT Admiral DCB was expanded for the treatment of failing AV access in patients with ESRD undergoing dialysis.Industry ProspectsPer a report by Allied Market Research, the global hemodialysis market size was valued at $71,501 million in 2017 and is expected to reach $99,747 million by 2025, witnessing a CAGR of 4.2% from 2018 to 2025. The key factors driving the market are the increasing incidents of hypertension and diabetes, which are leading to rise in the number of ESRD patients.Given the huge potential of the market, the approval has come at the right time.Price PerformanceThe company’s shares have gained 20% in the past year compared with the industry’s growth of 8.1%.Zacks Rank & Other Key PicksCurrently, Medtronic carries a Zacks Rank #2 (Buy).Some other top-ranked stocks from the broader medical space are Haemonetics Corporation HAE, National Vision Holdings, Inc EYE and ResMed Inc RMD.Haemonetics, currently flaunting a Zacks Rank #1 (Strong Buy), has a projected long-term earnings growth rate of 13.5%.National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently sports a Zacks Rank #1. stocks here.ResMed’s long-term earnings growth rate is estimated at 12.9%. It currently flaunts a Zacks Rank #1.5 Stocks Set to DoubleEach was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.Today, See These 5 Potential Home Runs >>
美敦力(Medtronic) plc MDT 公司宣布收到 FDA 对 IN 的许可。PACT AV 药物包衣气球治疗晚期肾脏病患者目前正在接受透析失败的动静脉通路。英军.PACT AV DCB 是一种紫杉醇涂层气球,将用于治疗。患有 ESRD 的患者进行手术以产生 AV 瘘管,使血液透析。然而,随着时间的推移,由于血管再狭窄,瘘管无法提供所需的通路.为了防止这种情况发生,美美敦力(Medtronic)公司一直致力于将这项技术应用于美国的外科医生,以帮助改善 ESRD 患者的生活。近期获批有望巩固公司在全球血液透析市场的立足点,扩大 DCB 产品的供应。 研究的 Peek Into FDA 的批准基于前瞻性、全球性、多中心、盲目性、随机(1:1)、研究设备豁免( IDE )研究的数据。该研究评估了智能网的安全性和有效性。PACT AV DCB 对美国、日本和新西兰29个地区的患者进行了研究。证明智能网优势的主要终点。PACT AV DCB 与经皮穿透光血管成形术(“ PTA ”)相比,是由欧洲心血管介入放射学会(“ CIRSE ”)提供的早期数据满足的。此外,在 VIVA 2019年提供的数据强调 DCB 的优越的通畅性,对于去 novo 和 recetamine 病变,以及所有研究类型的 AV 通路。为什么审批很重要?ESRD 患者每年必须进行维护手术,以恢复因血液透析而造成的瘘管病病变的功能,从而导致关键血液透析护理中断,并增加医疗费用。来自 IN 的枢轴随机结果。PACT AV 准入试验证明,它可以扩大再通术之间的差距,从而最大限度地扩大病人不间断地获得透析护理的机会。据该公司介绍,直到最近, AV 瘘管损伤还没有治疗方法,能够维持初级的通畅性,减少再通气。美美敦力(Medtronic)相信, FDA 的批准将使其扩大 IN 。PACT DCB 平台.该公司还计划利用智能网的技术。同样的 PACT 海军平台。值得注意的是,2016年, IN 的 CE 标志。在接受透析的 ESRD 患者中, PACT 外周血 DCB 被扩大用于治疗 AV 通路失败。行业前景根据联合市场研究公司的报告,2017年全球血液透析市场规模为71,501百万美元,预计到2025年将达到99,747百万美元,2018年至2025年的复合年增长率为4.2%。驱动市场的关键因素是高血压和糖尿病事件的增加,导致 ESRD 患者数量的增加。考虑到市场的巨大潜力,批准时机已经成熟。价格表现该公司股价在过去一年中上涨了20%,而该行业的涨幅为8.1%。Zacks 排名和其他关键选择目前,美敦力(Medtronic)公司拥有 Zacks 排名第二(购买)。其他一些来自更广泛医疗领域的顶级股票是 Haemonitics Corporation HAE 、 National Vision Holdings 、 Inc EYE 和 ResMed Inc RMD 。目前排名第一的 Haemotics 预测长期收益增长率为13.5%。National Vision 的长期盈利增长率估计为17.8%。该公司目前的体育 Zacks 排名第一。这里的股票。ResMed 的长期收益增长率估计为12.9%。它目前炫耀的 Zacks 排名1.5的股票设置为双倍每是手工挑选的 Zacks 专家作为#1最喜欢的股票,以获得+100%或更多在2020年。每一个都来自不同的部门,具有独特的品质和催化剂,可以促进异常增长。本报告中的大多数股票都是在华尔街的雷达下飞行的,这提供了一个很好的机会进入地面。今天,请参阅这5个潜在的首页运行>>