Medtronic's IN.PACT AV Access Study Results Bode Well

美敦力IN.PACT AV研究获积极结果,或为主动脉-外周心室领域重大突破

2019-09-11 12:00:45 YAHOO!FINANCE

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Medtronic plc MDT released the preliminary results from the IN.PACT AV Access clinical study. The study compared the investigational IN.PACT AV drug-coated balloon with percutaneous transluminal angioplasty in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. The results of the study, which met all primary safety and effectiveness endpoints, will prove to be a major stride forward for the company’s endeavor to treat patient suffering from renal diseases. This will likely be a major breakthrough in the Aortic Peripheral Ventricular (APV) business segment. Details of the Results The IN.PACT AV Access study is a randomized controlled trial (RCT), which has enrolled 330 subjects at 29 sites in United States, Japan and New Zealand. The study enrolled a complex patient population, which has been undergoing dialysis for an average of 4.3 years. Overall, the IN.PACT AV DCB group highlighted clinical benefit compared with the PTA control group. Among several crucial findings of the study, an outcome indicated that the primary patency rate of the target lesion at 180 days was 86.1% in the IN.PACT AV DCB group compared with 68.9% in the PTA control group. Moreover, per the Kaplan-Meier estimates, freedom from all-cause death through 360 days was 90.6% in the IN.PACT AV DCB study group compared with 90.4% in the PTA control group. The information complements the initial safety data presented at the FDA’s Advisory Committee meeting of the Circulatory System Devices Panel in June, which showed no difference in mortality rates in this patient population. These results assure that IN.PACT AV DCB not only addresses AV fistulae lesions, but also enhances the quality of life of patients undergoing dialysis. This newly-released data showcases the potential of IN.PACT AV DCB to treat restenosis in high-risk patients who currently avail few long-term treatment options. In the United States, the IN.PACT AV DCB is an investigational device and has not yet attained regulatory approval for commercial use. In January 2016, the CE indication for the IN.PACT Admiral DCB was extended for the treatment of failing arteriovenous access in patients with end-stage renal disease undergoing dialysis. Glimpse of APV Business In first-quarter fiscal 2020, APV revenues rose 1.7% at CER (down 0.2% as reported) to $467 million on high-single-digits growth in Venous and mid-single digits rise in Aortic. The upsides were partially offset by high-single digits decline in Peripheral. Market Prospects Per a report by MarketsAndMarkets, the peripheral vascular devices market is expected to see a CAGR of 6.8% and reach $14.4 billion by 2024. We believe that rising cases of peripheral artery disease, penetration of companies in untapped markets, more demand for minimally-invasive angioplasty procedures, technological advancements and increasing awareness among people will continue to drive global acceptance of the technology. Considering encouraging factors, we believe that the company’s development regarding IN.PACT Admiral DCB is strategic and is expected to broaden its customer base. Price Performance The stock has rallied 12.3% in the past year compared with the industry’s 0.2% growth.
美敦力公布了IN.PACT AV准入临床研究的初步结果。这项观察性研究比较了IN.PACT AV药物涂层球囊与经皮腔内血管成形术治疗新生或无支架再狭窄动静脉瘘病变的疗效。 这项研究的结果满足了所有主要的安全性和有效性指标,将被证明是该公司努力治疗肾病患者的一大进步。这可能是主动脉-外周心室(apv)业务领域的一个重大突破。 结果的细节 in.pact av接入研究是一项随机对照试验(rct),在美国、日本和新西兰的29个地点招募了330名受试者。 这项研究招募了一个复杂的病人群体,他们平均接受了4.3年的透析。总的来说,与pta对照组相比,in.pact av-dcb组突出了临床益处。在这项研究的几个关键发现中,结果表明,在180天时,in.pact av-dcb组的靶病变一级通畅率为86.1%,而pta对照组为68.9%。 此外,根据kaplan-meier的估计,in.pact av-dcb研究组在360天内免于全因死亡的比例为90.6%,而pta对照组为90.4%。这些信息补充了6月份在fda循环系统设备小组咨询委员会会议上提交的初步安全性数据,该会议显示这一患者群体的死亡率没有差异。这些结果保证了in.pact av-dcb不仅解决了av瘘管病变,而且提高了透析患者的生活质量。 这项最新公布的数据显示了in.pact av-dcb治疗高危患者再狭窄的潜力,这些患者目前很少有长期治疗选择。 在美国,in.pact av-dcb是一种试验设备,尚未获得商业用途的监管批准。2016年1月,在接受透析的终末期肾脏疾病患者的动静脉通路失败的治疗中,延长了in.pact上将DCB的CE适应证。 APV业务一瞥 在2020财年的第一季度,由于静脉血的高个位数增长和主动脉的中个位数增长,APV的收入在CER上升了1.7%(据报道下降了0.2%),达到4.67亿美元。上行部分被外围高个位数的下降所抵消。 市场前景 根据marketsandmarkets的一份报告,预计到2024年,外围血管设备市场的复合年增长率将达到6.8%,达到144亿美元。 我们相信,不断上升的外周动脉疾病病例、公司在尚未开发的市场的渗透、对微创血管成形术的更多需求、技术进步和人们日益提高的意识,将继续推动全球对这项技术的接受。考虑到一些令人鼓舞的因素,我们认为,该公司对in.pact上将dcb的发展具有战略意义,并有望扩大其客户群。 价格表现 与行业0.2%的增长率相比,该股去年上涨了12.3%。

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