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

Shockwave Medical, Inc.（属于强生医疗科技公司的一部分）宣布在美国推出其Shockwave Javelin外周IVL导管，这是一款新型的血管内碎石术（IVL）平台，旨在处理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平台具有与传统的Shockwave IVL导管相似的安全性和有效性，并且增强了该公司在IVL领域的市场领先地位。

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. People suffering from PAD have impaired quality of life and increased risk of heart attack or stroke. Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S.

外周动脉疾病是指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岁及以上的患者。患有外周动脉疾病的人生活质量下降，并且心脏病发作或中风的风险增加。慢性肢体威胁性缺血（CLTI）是外周动脉疾病中最先进和严重的形式，影响着美国近两百万患者。

It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer..

它与一年内40%的主要截肢率和五年内50%的死亡率相关，比大多数癌症的形式更糟糕。

“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，对更有效的穿越和治疗工具的需求日益增长，”基督医院林德纳研究中心和教育中心 PAD/CLI 项目医学主任 JD Corl 医学博士、FACC、FSCAI 表示。

“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.”.

“Shockwave的新IVL平台具有与现有IVL设备相似的经验证的安全性和有效性，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的CLTI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平台旨在处理钙化和交叉钙化闭塞性疾病或极度狭窄的病变，这些部位导丝可以通过，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 Nick West, 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.

“作为IVL技术的先驱，我们的目标是继续提供创新方案，以满足我们所服务的医生未被满足的需求，”Shockwave Medical首席医疗官Nick West博士说道。“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，该平台具备同时处理钙化和穿越极度狭窄血管的独特能力。”

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.”.

我们很自豪能够引领潮流，为血管内介入医生提供更多的灵活性，以解决关键的治疗需求，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的复杂钙化病变。

Condition:

条件：

Peripheral Artery Disease

外周动脉疾病

Type:

类型：

drug

药物