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飞利浦推出PAD治疗设备试验，首次成功患者手术

花匠小妙招
2024-11-05 23:35

[Image courtesy of Philips]Philips recently announced the first U.S. treatment using its new laser device that combines two peripheral artery disease (PAD) procedures into one.

[图片由飞利浦提供]飞利浦最近宣布，美国首次使用其新型激光设备进行治疗，该设备将两种外周动脉疾病（PAD）程序结合在一起。

The Cardiovascular Institute of the South in Louisiana used the device to treat a 78-year-old male patient with PAD, marking a significant step in advancing PAD care. This first procedure marks the launch of the company’s THOR IDE study.

路易斯安那州南方心血管研究所（The Cardiovascular Institute of The South in Louisiana）使用该设备治疗了一名78岁的男性PAD患者，标志着PAD护理取得了重大进展。这第一个程序标志着该公司THOR IDE研究的启动。

“Developing and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,” said Drs. Craig Walker and McCall Walker of Cardiovascular Institute of the South in Louisiana. “This trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.”.

路易斯安那州南方心血管研究所的克雷格·沃克（CraigWalker）和麦考尔·沃克（McCallWalker）博士说：“开发和推动临床证据对于改善护理和指导采用飞利浦激光切除术和碎石系统等新技术至关重要。”。“这项试验将提供必要的数据来证明这种联合方法如何在治疗具有挑战性的钙化病变方面优化手术效率和患者结果。”。

Simplifying complex PAD treatments

PAD affects millions of people globally, Philips said. It leads to reduced blood flow in the limbs and results in pain, ulcers and sometimes amputations. Traditional treatments for PAD typically require multiple steps and devices, increasing procedural complexity and risk.

飞利浦表示，PAD影响全球数百万人。。PAD的传统治疗通常需要多个步骤和设备，增加了程序的复杂性和风险。

The Philips laser catheter simplifies the process by combining two critical PAD treatments—laser-driven atherectomy to remove plaque and intravascular lithotripsy to modify or disrupt calcium deposits. Unlike conventional methods, Philips’ device creates sonic shockwaves using a pulsed laser, eliminating the need for separate ultrasound devices..

飞利浦激光导管通过结合两种关键的垫治疗-激光驱动的动脉切除术来去除斑块和血管内碎石术来改变或破坏钙沉积，从而简化了过程。与传统方法不同，飞利浦的设备使用脉冲激光产生声波冲击波，不需要单独的超声波设备。。

“A result of Philips’ extensive in-house innovation and development capabilities, our combined laser atherectomy and intravascular lithotripsy device reflects our commitment to providing physicians with the tools they need to tackle complex vascular challenges more efficiently and effectively, potentially transforming treatment paradigms for peripheral artery disease.

“由于飞利浦拥有广泛的内部创新和开发能力，我们的激光血管切除术和血管内碎石术联合装置反映了我们的承诺，即为医生提供所需的工具，以更有效地应对复杂的血管挑战，从而有可能改变外周动脉疾病的治疗模式。

Philips is dedicated to clinically validating its innovations through rigorous trials and does so in collaboration with strong clinical partners,” said Stacy Beske, business leader for Philips Image Guided Therapy Devices..

飞利浦致力于通过严格的试验在临床上验证其创新，并与强大的临床合作伙伴合作，”飞利浦图像引导治疗设备业务负责人Stacy Beske说。。

THOR IDE aims to validate safety and efficacy

THOR IDE旨在验证安全性和有效性

Philips’ THOR IDE clinical study is now underway, and the first U.S. patient has been enrolled. The study will assess the device’s safety and efficacy in a single-arm, multicenter study involving up to 155 patients across 30 sites in the U.S.

飞利浦公司的THOR IDE临床研究正在进行中，第一名美国患者已经入选。该研究将在一项单臂多中心研究中评估该设备的安全性和有效性，该研究涉及美国30个地点的155名患者。

The study will focus on achieving successful outcomes with minimal complications. The primary endpoints include freedom from major adverse events such as mortality, unplanned amputations, clinically driven target lesion revascularization within 30 days of the procedure, and achieving less than or equal to 50% residual stenosis post-procedure.

这项研究将侧重于以最小的并发症取得成功的结果。主要终点包括无重大不良事件，如死亡率，非计划截肢，手术后30天内临床驱动的靶病变血运重建，以及手术后残余狭窄小于或等于50%。

Patients will be following for 12 months..

患者将随访12个月。。

“This innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important U.S. clinical trial,” said Dr. Genovese, vascular surgeon and co-principal investigator of the THOR trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania.

“这种创新的血管准备方法可以改善患者的预后，同时最大程度地减少对多种疗法和干预措施的需求。这使得这成为一个令人兴奋的创新里程碑，因为我们在这项重要的美国临床试验中招募了第一名患者，”宾夕法尼亚大学医院宾夕法尼亚高级肢体保存中心THOR试验的血管外科医生兼联合首席研究员Genovese博士说。

“Integrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.”.

“将动脉切除术和血管内碎石术整合到单一设备中，有可能彻底改变与中度至重度钙化相关的复杂股腘病变患者的治疗方法。”。

This laser-based PAD treatment system by Philips is currently investigational and not commercially available.

飞利浦的这种基于激光的PAD治疗系统目前正在研究中，尚未上市。