Shockwave Medical在美国推出新型 Forward血管内碎石平台，以变革难以通过的钙化病变的治疗方式-动脉网

Shockwave Medical Launches Novel Forward Intravascular Lithotripsy Platform in U.S. to Transform Treatment of Difficult-to-Cross Calcified Lesions

CISION 等信源发布 2025-03-04 20:59

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Now available in the U.S., the Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter safely modifies and crosses occlusive or extremely narrowed calcific peripheral artery disease

现在在美国上市的Shockwave Javelin外周血管内碎石术导管，能够安全地改变并穿过闭塞性或极度狭窄的钙化外周动脉疾病。

SANTA CLARA, Calif.

加利福尼亚州圣克拉拉

，

March 4, 2025

2025年3月4日

/PRNewswire/ -- Today, Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the U.S. launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).

/PRNewswire/ -- 今天，Shockwave Medical, Inc.（隶属于强生医疗科技公司，是循环恢复领域的全球领导者）宣布在美国推出其Shockwave Javelin外周IVL导管，这是一种新型的血管内碎石术（IVL）平台，旨在修饰钙化并穿越患有外周动脉疾病（PAD）患者的极度狭窄血管。

The first-of-its-kind forward IVL platform has a similar safety and efficacy profile of legacy Shockwave IVL catheters and bolsters the company's market-leading IVL portfolio. .

首个同类前向IVL平台具有与传统Shockwave IVL导管相似的安全性和有效性，并增强了该公司市场领先的IVL产品组合。

继续阅读

Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD).

Shockwave Javelin Peripheral IVL 导管，一种新型的血管内碎石 (IVL) 平台，旨在修饰钙化并穿越外周动脉疾病 (PAD) 患者极度狭窄的血管。

PAD is the narrowing or blockage of the vessels that carry blood from the heart to the legs, reducing blood flow and affecting more than eight million people aged 40 and older in the U.S.

PAD是将血液从心脏输送到腿部的血管变窄或阻塞，导致血流减少，影响美国超过八百万名40岁及以上的人。

1,2

People suffering from PAD have impaired quality of life and increased risk of heart attack or stroke.

患有PAD的人生活质量受损，心脏病发作或中风的风险增加。

Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.

慢性肢体威胁性缺血（CLTI）是外周动脉疾病（PAD）中最先进和最严重的形式，影响着美国近两百万患者。其一年内主要截肢率为40%，五年死亡率为50%，比大多数癌症的预后更差。

'Physicians have faced significant challenges in tackling complex calcific lesions in narrowed peripheral vessels, and there is a growing need for more effective crossing and treatment tools,' said JD Corl, M.D., FACC, FSCAI, Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital..

“医生在处理狭窄的外周血管中的复杂钙化病变时面临重大挑战，对更有效的穿通和治疗工具的需求日益增长，”JD Corl医学博士、FACC、FSCAI、基督医院林德纳研究中心和教育中心PAD/CLI项目的医学主任表示。

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'With proven safety and effectiveness similar to existing IVL devices, Shockwave's new IVL platform will bring a transformative approach to our peripheral practices, enabling us to make cases more efficient and optimize outcomes for our patients living with PAD, especially those with more complex CLTI.' .

“凭借与现有IVL设备相似的经过验证的安全性和有效性，Shockwave的新IVL平台将为我们的外周手术带来变革性的方法，使我们能够提高病例处理效率，并优化PAD患者尤其是那些患有更复杂CLTI的患者的治疗效果。”

The forward IVL platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150 centimeters and features a single distal emitter that creates up to 120 shockwave pulses.

前向IVL平台旨在治疗钙化和交叉闭塞性疾病或极狭窄的病变，这些病变导丝可以通过，但器械可能无法通过。Shockwave Javelin的工作长度为150厘米，并配备一个远端发射器，可产生多达120个冲击波脉冲。

Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to calcium than the balloon-based platform. Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD IDE trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters..

每次冲击波脉冲都会产生一个超出导管尖端的球形能量场。这种新颖的设计使得碎石术能够比基于球囊的平台更靠近钙化部位。尽管所研究的钙化病变具有挑战性，但FORWARD PAD IDE 试验的临床结果表明，Shockwave Javelin 的安全性和有效性与基于球囊的 Shockwave IVL 导管相似。

'As the pioneer of IVL technology, our goal is to continue to deliver innovations that address the unmet needs of the physicians that we serve,' said

“作为IVL技术的先驱，我们的目标是继续提供创新，以满足我们所服务的医生未被满足的需求，”

Nick West

尼克·韦斯特

, M.D., Chief Medical Officer, Shockwave Medical. 'By listening to and leveraging their valuable insights, we developed our transformational forward IVL platform with the unique capability to both modify calcium and cross extremely narrowed vessels. We are proud to be leading the charge in offering endovascular interventionalists more flexibility to address critical treatment needs and potentially reduce the risks associated with CLTI for their patients.' .

医学博士，Shockwave Medical首席医疗官表示：“通过倾听并利用他们宝贵的见解，我们开发了具有变革意义的前向IVL平台，该平台具有独特的修改钙化和穿越极度狭窄血管的能力。我们很自豪能够引领潮流，为血管内介入医生提供更大的灵活性，以应对关键的治疗需求，并有可能降低与CLTI相关的风险，从而造福患者。”

Combined with Shockwave E8, Shockwave L6, Shockwave M5+, and Shockwave S4 IVL catheters, the addition of the Shockwave Javelin Peripheral IVL catheter offers physicians a comprehensive IVL portfolio to treat challenging calcified lesions above and below the knee across the entire peripheral anatomy. .

结合Shockwave E8、Shockwave L6、Shockwave M5+ 和 Shockwave S4 IVL导管，新增的Shockwave Javelin Peripheral IVL导管为医生提供了一套全面的IVL产品组合，用于治疗膝上和膝下整个外周解剖结构中具有挑战性的钙化病变。

About Shockwave Medical

关于Shockwave Medical

Shockwave Medical Inc., part of Johnson & Johnson MedTech, 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 Inc. 是强生医疗科技的一部分，是开发和商业化创新产品的领导者，这些产品正在改变心血管疾病的治疗方式。其首创的血管内碎石术 (IVL) 技术通过安全使用声压波来破坏难以处理的钙化斑块，从而显著改善了患者的治疗效果，彻底改变了动脉粥样硬化性心血管疾病的治疗方法。

Its Reducer technology, which is under clinical investigation in .

其Reducer技术正在临床研究中。

the United States

美国

and is CE Marked in the European Union and the

并且在欧盟和

United Kingdom

英国

, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at

，旨在通过重新分配心脏内的血液流动，为全球数百万难治性心绞痛患者提供缓解。欲了解更多信息，请访问

www.shockwavemedical.com

。

Cardiovascular Solutions from Johnson & Johnson MedTech

来自强生医疗科技的心血管解决方案

Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation.

在强生公司，我们正在应对世界上最复杂和普遍的健康挑战。通过心血管产品组合，我们为医疗保健专业人员提供先进的标测和导航、微型技术和精确消融技术，针对心力衰竭、冠状动脉疾病、中风和心房颤动等具有重大未满足需求的病症进行治疗。

We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. .

我们是心脏康复、循环系统修复和心律失常治疗的全球领导者，同时也是神经血管护理领域新兴的领导者，致力于攻克全球两大主要死亡原因：心力衰竭和中风。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的实力使我们能够构建一个世界，在这个世界里，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且更少侵入性，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今全面的医疗保健解决方案领域进行创新，以提供明日的突破性成果，并对人类健康产生深远影响。

Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at .

了解我们的医疗技术部门在全球范围内的规模以及在心血管、骨科、外科和视觉解决方案方面的深厚专业知识。

https://thenext.jnjmedtech.com

. Follow us at

关注我们

@JNJMedTech

and on

并且继续

领英

. Shockwave Medical, Inc. is part of Johnson & Johnson MedTech.

Shockwave Medical, Inc. 是强生医疗科技公司的一部分。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding the Shockwave Javelin Peripheral IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

本新闻稿包含《1995年私人证券诉讼改革法案》中定义的关于Shockwave Javelin外周IVL导管的“前瞻性声明”。读者应注意不要依赖这些前瞻性声明。这些声明是基于对未来事件的当前预期。

If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment.

如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与Shockwave Medical, Inc.和/或Johnson & Johnson的预期和预测大相径庭。风险和不确定性包括但不限于：商业成功的不确定性；专利面临的挑战；竞争，包括技术进步、竞争对手获得的新产品和专利；生产困难和延误；产品功效或安全性问题导致的产品召回或监管行动；适用法律法规的变化，包括全球医疗改革；医疗卫生产品和服务购买者行为及支出模式的变化；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述，请参见强生公司最近的Form 10-K年度报告，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的Form 10-Q季度报告和其他提交给证券交易委员会的文件。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

，

www.jnj.com

or on request from Johnson & Johnson. Neither Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

或应强生公司的要求。Shockwave Medical, Inc. 和强生公司均不承担因新信息、未来事件或发展而更新任何前瞻性声明的责任。

†

Dr. Corl is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release.

Corl博士是Shockwave Medical的付费顾问。他未因本新闻稿获得报酬。

https://www.cdc.gov/heart-disease/about/peripheral-arterial-disease.html

https://www.nhlbi.nih.gov/health/peripheral-artery-disease

https://www.nhlbi.nih.gov/health/外周动脉疾病

https://www.ahajournals.org/doi/full/10.1161/CIRCOUTCOMES.120.007539

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