FastWave Medical, a pioneering intravascular lithotripsy (IVL) startup, has secured Institutional Review Board (IRB) approval to commence a coronary feasibility study utilizing Sola

FastWave Medical，一家开创性的血管内碎石术（IVL）初创公司，已获得机构审查委员会（IRB）批准，开始使用Sola进行冠状动脉可行性研究。

, its novel laser IVL (L-IVL) system. FastWave is partnering with Clinical Accelerator to achieve this milestone, paving the way for its planned U.S. pivotal trial.

其新型激光IVL（L-IVL）系统。FastWave正与Clinical Accelerator合作实现这一里程碑，为其计划中的美国关键试验铺平道路。

FastWave's next-generation Sola

FastWave的下一代Sola

L-IVL system empowers physicians treating cardiovascular calcium with sleek, rupture-resistant balloon catheters. With a custom laser energy source that produces actuating, circumferential sonic pressure waves with unmatched precision and consistency, FastWave's Sola

L-IVL系统通过使用光滑、抗破裂的球囊导管，赋予医生治疗心血管钙化的强大能力。配备定制的激光能源，产生具有无与伦比精确性和一致性的驱动型周向声压波，FastWave的Sola

platform allows for improved operator control to safely and effectively modify calcium. FastWave aims to set a new bar in coronary artery disease treatment with its Sola

该平台能够提升操作人员的控制能力，以安全有效地改变钙化。FastWave旨在通过其Sola技术为冠状动脉疾病治疗树立新的标杆。

L-IVL system, resulting in superior patient outcomes.

L-IVL系统，从而获得更优的患者预后。

'FastWave's laser IVL system is sophisticated, yet very easy to use. It holds a lot of promise for reshaping complex arterial disease treatment, enabling cardiologists to treat calcified arteries with more precision and efficiency,' said Dr. Amir Kaki, Director of Mechanical Circulatory Support and High-Risk Coronary Interventions at Henry Ford St.

“FastWave的激光IVL系统复杂精密，但非常易于使用。它在重塑复杂动脉疾病治疗方面具有很大的潜力，使心脏病学家能够更精确、高效地治疗钙化动脉，”亨利福特医院机械循环支持和高危冠状动脉介入主任Amir Kaki博士说道。

John Hospital..

约翰医院。。

'Our committed team is aiming to set a new standard in the IVL category, enabling physicians to achieve best-in-class clinical outcomes. This IRB approval represents a major milestone in our mission to deliver transformative technology to physicians and their patients,' said

“我们致力于在IVL类别中树立新标准，帮助医生实现最佳的临床效果。这项IRB批准代表了我们向医生及其患者提供变革性技术的使命中的一个重要里程碑，”

Scott Nelson

斯科特·纳尔逊

, co-founder and CEO of FastWave.

FastWave 的联合创始人兼首席执行官。

In addition to this coronary feasibility study, FastWave looks forward to commencing a U.S. Investigational Device Exemption (IDE) pivotal trial this year for the treatment of peripheral artery disease with its Artero

除了这项冠状动脉可行性研究外，FastWave 期待在今年开始其 Artero 治疗外周动脉疾病 (PAD) 的美国试验用医疗器械豁免 (IDE) 关键试验。

electric IVL (E-IVL) system.

电动IVL（E-IVL）系统。

'FastWave is taking the reins and rapidly advancing IVL therapy with its differentiated peripheral and coronary systems. On behalf of my fellow interventionalists, we're genuinely excited to have more IVL options to treat patients with complex arterial disease,' said Dr.

“FastWave正在迅速推进IVL治疗，并通过其差异化的外周和冠状动脉系统取得领先地位。代表我的介入科同事，我们真的很兴奋能够有更多IVL选择来治疗复杂动脉疾病的患者，”博士说道。

Art Lee, Director of Peripheral Vascular Services at TCAVI in Gainesville, FL.

Art Lee，TCAVI外周血管服务总监佛罗里达州盖恩斯维尔

About FastWave Medical

关于FastWave Medical

FastWave Medical is pioneering next-generation intravascular lithotripsy (IVL) technology designed to transform the treatment of calcific artery disease in both peripheral and coronary applications. Founded by industry veterans with extensive startup and multinational medical device experience, FastWave has secured over .

FastWave Medical 正在开创下一代血管内碎石术 (IVL) 技术，旨在变革外周和冠状动脉应用中钙化动脉疾病的治疗。公司由具有广泛初创企业和跨国医疗器械经验的行业资深人士创立，FastWave 已获得超过 。

$40 million

4000万美元

in venture funding to date, supporting the advancement of its dual-platform IVL technology.

迄今为止已获得风险投资，以支持其双平台IVL技术的发展。

The company's innovations address key limitations in current calcium-modification approaches through enhanced deliverability, increased energy output, and improved usability, eliminating cumbersome procedural steps while maintaining the simplicity that has driven IVL's rapid clinical adoption. Learn more at .

公司创新解决了当前钙化修饰方法的关键局限性，通过增强递送能力、提高能量输出和改善可用性，消除了繁琐的操作步骤，同时保留了推动IVL快速临床应用的简洁性。欲了解更多信息，请访问。

About Clinical Accelerator

关于Clinical Accelerator

Clinical Accelerator is a global CRO specializing in the study of innovative medical device studies by facilitating early entry into the clinic and ensuring fast and efficient implementation of First-in-Human (FIH) and Early Feasibility Studies (EFS). With extensive experience in trial execution, Clinical Accelerator partners with companies of all sizes to bring groundbreaking solutions to patients worldwide.

Clinical Accelerator是一家全球性的合同研究组织（CRO），专注于通过促进创新医疗器械研究的早期临床进入，确保首次人体试验（FIH）和早期可行性研究（EFS）的快速高效实施。凭借在试验执行方面的丰富经验，Clinical Accelerator与各种规模的公司合作，将突破性解决方案带给全球患者。