SANTA CLARA, Calif., April 08, 2024 (GLOBE NEWSWIRE) -- Shockwave Medical Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, today announced that investigators presented six-month data from the full population of the REDUCER-I study, alongside interim long-term follow-up results to three years.

加利福尼亚州圣克拉拉，2024年4月8日（环球通讯社）--Shockwave Medical Inc.（纳斯达克：SWAV）是心血管疾病治疗转化技术开发和商业化的先驱，今天宣布，研究人员提供了REDUCER-I研究全部人群的六个月数据，以及三年的中期长期随访结果。

These findings confirm the positive, ‘real-world’ outcomes of Shockwave Reducer, a novel technology for the treatment of refractory angina. Results were presented earlier today at the 73rd Annual Scientific Sessions of the American College of Cardiology in Atlanta, GA..

这些发现证实了冲击波减少剂（一种治疗难治性心绞痛的新技术）的积极“现实世界”结果。今天早些时候，在佐治亚州亚特兰大举行的美国心脏病学会第73届年度科学会议上公布了研究结果。。

REDUCER-I is a post-market, multi-center, observational study designed to collect long-term outcomes on Shockwave Reducer in a large, ‘real-world’ population of 400 patients. The lead enrollers of the study were Drs. Stefan Verheye1, ZNA Middelheim Hospital, Antwerp, Belgium, Tim van de Hoef, University Medical Center Utrecht, Utrecht, Netherlands, and Ranil de Silva, Royal Brompton and Harefield Hospitals, London, United Kingdom..

REDUCER-I是一项上市后的多中心观察性研究，旨在收集400名患者的大型“现实世界”人群中冲击波减速器的长期结果。该研究的主要参与者是比利时安特卫普ZNA Middelheim医院的Stefan Verheye1博士，荷兰乌得勒支大学医学中心的Tim van de Hoef以及英国伦敦皇家布朗普顿和哈雷菲尔德医院的Ranil de Silva。。

The primary effectiveness endpoint for the study was the percentage of patients experiencing improvement in their symptoms of angina defined as a reduction in Canadian Cardiovascular Society (CCS) grade at six months compared with baseline. The primary safety endpoints were the rate of device- and/or procedure-related periprocedural serious adverse events (SAEs) and major adverse cardiac events (MACE) up to 30 days post implant..

该研究的主要有效性终点是心绞痛症状改善的患者百分比，定义为与基线相比，六个月时加拿大心血管学会（CCS）评分降低。主要安全性终点是植入后30天内器械和/或手术相关的围手术期严重不良事件（SAE）和主要不良心脏事件（MACE）的发生率。。

Six-month results demonstrated an improvement in ≥1 CCS class in 70% of patients, and ≥2 CCS classes in 24% of patients. The proportion of patients with CCS class III/IV declined from 72% at baseline to 18% at six months, with a mean change in CCS class of -0.9 ± 0.8 (p<0.0001). Reduction in symptoms of angina was consistent at longer-term follow-up, with CCS class III/IV symptoms experienced by only 15% of patients at two years and 11% at three years (p<0.0001).

六个月的结果显示，70%的患者≥1 CCS分级改善，24%的患者≥2 CCS分级改善。CCS III/IV级患者的比例从基线时的72%下降到6个月时的18%，CCS级的平均变化为-0.9±0.8（p<0.0001）。在长期随访中，心绞痛症状的减轻是一致的，两年时只有15%的患者出现CCS III/IV级症状，三年时只有11%（p<0.0001）。

Use of Shockwave Reducer also demonstrated a very favorable safety profile, with SAE and MACE rates uniformly low at 1.1% and 1.6%, respectively..

冲击波减速器的使用也显示出非常有利的安全性，SAE和MACE率分别低至1.1%和1.6%。。

“Results from the REDUCER-I study continue to demonstrate the safety and effectiveness of Shockwave Coronary Sinus Reducer as a novel therapy for refractory angina,” said Dr. Verheye. “We observed consistent reduction in symptoms of refractory angina and improvements in quality of life, results which align with those from the COSIRA study, previously published in The New England Journal of Medicine, in a challenging patient cohort characterized by high rates of cardiovascular risk factors and coexisting comorbidities for whom there have historically been no other treatment options.”.

“REDUCER-I研究的结果继续证明冲击波冠状窦减压器作为难治性心绞痛的新疗法的安全性和有效性，”Dr。维赫耶。“我们观察到难治性心绞痛症状持续减轻，生活质量改善，这与之前发表在《新英格兰医学杂志》上的COSIRA研究结果一致，这是一个具有挑战性的患者队列，其特征是心血管危险因素发生率高，并且历史上没有其他治疗选择的共存合并症。”。

COSIRA-II, a US IDE double-blind randomized sham-controlled clinical trial, is currently enrolling patients to evaluate further the safety and effectiveness of Shockwave Reducer for the treatment of patients with refractory angina and no conventional revascularization options. Results from COSIRA-II are intended to support the regulatory filing for US FDA approval of Shockwave Reducer.

COSIRA-II是一项美国IDE双盲随机假对照临床试验，目前正在招募患者，以进一步评估冲击波减少剂治疗难治性心绞痛且无常规血运重建选择的患者的安全性和有效性。COSIRA-II的结果旨在支持美国FDA批准冲击波减速器的监管备案。

Shockwave Reducer is an investigational device, limited by U.S. law to investigational use..

冲击波减速器是一种研究装置，受美国法律限制用于研究用途。。

Additional Reducer Data Presented At ACC

ACC提供的其他减速器数据

In a separate late-breaking clinical trial session at ACC, Michael Foley, MD, National Heart and Lung Institute, Imperial College, London, UK, presented data from the ORBITA-COSMIC trial (Principal Investigator Dr. Rasha Al-Lamee, MD PhD), a randomized, placebo-controlled, double-blind, multicenter trial investigating the efficacy of Shockwave Coronary Sinus Reducer.

在ACC的另一次晚期临床试验会议上，英国伦敦帝国理工学院国家心肺研究所医学博士Michael Foley介绍了ORBITA-COSMIC试验（首席研究员Rasha Al-Lamee博士，医学博士）的数据，这是一项随机，安慰剂对照，双盲，多中心试验，研究冲击波冠状窦减压器的疗效。

The study confirmed symptomatic relief from angina over time in patients that had received Reducer. Although the trial missed the primary imaging endpoint of myocardial blood flow assessed by magnetic resonance imaging, there was evidence of redistribution of blood flow to the subendocardial ischemic regions, supporting the putative mechanism of action of Shockwave Reducer.

该研究证实，随着时间的推移，接受减量治疗的患者心绞痛症状缓解。尽管该试验错过了通过磁共振成像评估的心肌血流的主要成像终点，但有证据表明血流重新分布到心内膜下缺血区域，支持了冲击波减少剂的假定作用机制。

ORBITA-COSMIC provides additional evidence for the use of Reducer as an additional therapeutic option for patients with refractory angina, documented myocardial ischemia and no option for conventional revascularization..

ORBITA-COSMIC为使用还原剂作为难治性心绞痛患者的额外治疗选择提供了额外的证据，记录了心肌缺血，并且没有常规血运重建的选择。。

About Shockwave Medical, Inc.

关于Shockwave Medical，Inc。

Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes.

Shockwave Medical是创新产品开发和商业化的领导者，这些创新产品正在改变心血管疾病的治疗方法。其首创的血管内碎石术（IVL）技术通过安全地使用声压波破坏具有挑战性的钙化斑块，改变了动脉粥样硬化性心血管疾病的治疗方法，从而显着改善了患者的预后。

Shockwave Medical has also recently acquired Reducer, which is under clinical investigation in the United States and Canada and is CE Marked in the European Union and the United Kingdom. By redistributing blood flow within the heart, Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina.

Shockwave Medical最近还收购了Reducer，该公司正在美国和加拿大进行临床研究，并在欧盟和英国进行CE标记。通过重新分配心脏内的血流，Reducer旨在为全球数百万患有难治性心绞痛的患者提供缓解。

Learn more at www.shockwavemedical.com..

更多信息，请访问www.shockwavemedical.com。。

About Reducer

关于减速器

Shockwave Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies.

Shockwave Reducer在欧盟被CE标记用于治疗难治性心绞痛，这是一种痛苦而衰弱的疾病，当冠状动脉向心肌输送的血液不足时，尽管使用标准的血运重建或心脏药物疗法进行治疗。

It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. Reducer has been shown to provide relief from symptoms of angina in patients lacking conventional revascularization options. Placement of Reducer is performed using a minimally invasive transvenous procedure.

它影响着全世界数百万患者，这些患者通常由于其致残症状而导致生命受到严重限制，其发病率正在上升。Reducer已被证明可以缓解缺乏常规血运重建选择的患者的心绞痛症状。使用微创经静脉手术进行减压器的放置。

While Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to Reducer in October 2018, and it is being studied in the COSIRA-II clinical trial..

虽然Reducer在美国未被批准用于商业用途，但FDA于2018年10月授予Reducer突破性设备名称，目前正在COSIRA-II临床试验中进行研究。。

Forward-Looking Statements

前瞻性声明

This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms.

本新闻稿包含与我们的期望、预测、信念和前景有关的声明，这些声明是1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。在某些情况下，您可以通过前瞻性词语来识别这些陈述，例如“可能”、“可能”、“将”、“应该”、“期望”、“计划”、“预期”、“相信”、“估计”、“预测”、“潜在”或“继续”，以及类似的表达方式，以及这些术语的负面影响。

Forward-looking statements in this press release include, but are not limited to, statements regarding potential future results of pending clinical trials and the timing and efficacy of, and our ability to obtain, regulatory approval for our products. You are cautioned not to place undue reliance on these forward-looking statements.

本新闻稿中的前瞻性声明包括但不限于关于未决临床试验的潜在未来结果以及我们产品获得监管批准的时间和功效以及我们获得监管批准的能力的声明。提醒您不要过度依赖这些前瞻性声明。

Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware..

前瞻性陈述仅是基于我们当前的预期、估计和假设的预测，仅在做出之日有效，并受到风险和不确定性的影响，其中一些我们目前尚不清楚。。

Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements are discussed in our filings with the Securities and Exchange Commission (SEC), including in the sections titled “Risk Factors” in our most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in our other reports filed with the SEC.

我们向美国证券交易委员会（SEC）提交的文件中讨论了可能导致我们的实际业绩和财务状况与前瞻性报表中所示存在重大差异的重要因素，包括我们最近的10-K表年度报告和随后提交的10-Q表季度报告中题为“风险因素”的部分，以及我们向SEC提交的其他报告中的部分。

Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations..

除法律要求外，我们不承诺在本协议日期后更新任何前瞻性声明，以使这些声明符合实际结果或修订后的预期。。

Media Contact:

媒体联系人：

Scott Shadiow

Scott Shadiow

+1.317.432.9210

+1.317.432.9210

sshadiow@shockwavemedical.com

sshadiow@shockwavemedical.com

Investor Contact:

投资者联系人：

Debbie Kaster

Debbie Kaster

dkaster@shockwavemedical.com

dkaster@shockwavemedical.com

1Dr. Verheye is a paid consultant of Shockwave Medical. He has not been compensated in connection with this press release.

1Dr。Verheye是Shockwave Medical的付费顾问。他没有得到与本新闻稿有关的赔偿。