Cordis宣布两项大型研究取得积极结果，证明SELUTION SLR™药物洗脱球囊在复杂外周动脉疾病患者中的持久疗效-动脉网

Cordis Announces Positive Results from Two Major Studies Demonstrating Durable Efficacy of SELUTION SLR™ Drug-Eluting Balloon in Complex Peripheral Artery Disease Patients

CISION 等信源发布 2025-04-25 08:30

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SELUTION SLR™ Drug-Eluting Balloon (DEB) achieves amongst the highest reported patency for any drug-eluting or drug-coated technology at 3 years in the SELUTION SFA Japan Trial, with 81.5% primary patency.

在SELUTION SFA日本试验中，SELUTION SLR™药物洗脱球囊（DEB）在3年内的通畅率达到了药物洗脱或药物涂层技术中报告的最高水平之一，主要通畅率为81.5%。

SELUTION SLR™ DEB demonstrates real-world effectiveness and consistency across complex and varied patient populations. The SUCCESS Study 12-month primary endpoint showed: Freedom from CD-TLR – overall population of 91.1%, claudicants 91.3%, and CLTI 90.3%.

SELUTION SLR™ DEB 在复杂且多样的患者群体中展现了真实世界中的有效性和一致性。SUCCESS 研究 12 个月的主要终点显示：整体人群免于 CD-TLR 的比率为 91.1%，间歇性跛行患者为 91.3%，CLTI 患者为 90.3%。

MIAMI LAKES, Fla.

迈阿密湖，佛罗里达州

，

April 24, 2025

2025年4月24日

/PRNewswire/ --

Cordis

康蒂斯

, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB). The SUCCESS PTA Study 12-month results were presented on

，一家在全球心血管和血管内介入技术领域的领导者，宣布了两项主要外周研究的新数据，这些研究评估了SELUTION SLR™药物洗脱球囊（DEB）。SUCCESS PTA研究的12个月结果已在当天发布。

April 23

4月23日

at the Charing Cross Symposium in

在查令十字研讨会上

London

伦敦

. The SELUTION SFA Japan Trial 3-year results followed on

. SELUTION SFA日本试验的3年结果如下

April 25

4月25日

at the Japan Endovascular Treatment Conference in

在日本血管内治疗会议

Osaka

大阪

. The studies confirm the sustained efficacy and safety of SELUTION SLR™ DEB in treating complex peripheral artery disease (PAD) across diverse, real-world patient populations, favorably matching best-in-class benchmarks from paclitaxel-eluting technologies.

这些研究证实了SELUTION SLR™ DEB在治疗复杂的外周动脉疾病（PAD）时，在不同的真实世界患者群体中持续有效且安全，其结果与紫杉醇洗脱技术的最佳标杆相当。

继续阅读

Cordis, a global leader in interventional cardiovascular and endovascular technologies, announced new data from two major peripheral studies evaluating the SELUTION SLR™ Drug-Eluting Balloon (DEB).

科迪斯（Cordis），作为全球心血管和血管内介入技术的领导者，宣布了两项主要外周研究的新数据，这些研究评估了SELUTION SLR™药物洗脱球囊（DEB）。

3-Year Results – SELUTION SFA Japan Trial: First Sirolimus DEB with Proven Long-Term Outcomes

3年结果——SELUTION SFA日本试验：首个证明具有长期疗效的西罗莫司药物球囊

The SELUTION SFA Japan trial, a prospective, single-arm trial conducted at 13 sites across

SELUTION SFA日本试验，一项在13个地点进行的前瞻性、单臂试验，

Japan

日本

, evaluated the performance of SELUTION SLR™ DEB in 134 complex patients. At 3 years, SELUTION SLR™ DEB demonstrated primary patency of 81.5% and freedom from Clinically Driven Target Lesion Revascularization (CD-TLR) of 93.8%. These results demonstrate that SELUTION SLR™ DEB is the only drug-eluting technology with core-lab adjudicated 3-year patency over 80%..

，评估了SELUTION SLR™ DEB在134名复杂患者中的表现。在3年时，SELUTION SLR™ DEB显示出81.5%的主要通畅率和93.8%的无临床驱动的目标病变血运重建（CD-TLR）率。这些结果表明，SELUTION SLR™ DEB是唯一一种经过核心实验室裁定、3年通畅率超过80%的药物洗脱技术。

'SELUTION SLR™ DEB represents the next evolution in Leave-Nothing-Behind treatment strategies. These 3-year outcomes demonstrate unprecedented durability in complex patients with primary patency greater than 80%. In contrast, paclitaxel drug-coated balloon studies have shown significant loss of patency in the same time period,' said Dr.

“SELUTION SLR™ DEB 代表了‘不留痕迹’治疗策略的下一步演变。这些三年的成果表明，在复杂患者中，其主要通畅率超过 80%，显示出前所未有的持久性。相比之下，紫杉醇药物涂层球囊研究在同一时间段内显示出通畅率显著下降。”博士说道。

Iida, MD, of the Cardiovascular Division at .

井田，心血管科医学博士。

Osaka

大阪

Police Hospital,

警察医院，

Japan

日本

and Study Principal Investigator.

首席研究员。

12-Month Outcomes – The SUCCESS PTA Study: Real-World Results in a PAD Population

12个月结果 – SUCCESS PTA研究：PAD人群的真实世界结果

The SUCCESS PTA Study is a prospective, observational global registry evaluating SELUTION SLR™ DEB in 723 patients across 27 sites in

SUCCESS PTA研究是一项前瞻性、观察性全球注册研究，评估了在27个中心的723名患者中使用SELUTION SLR™药物球囊的情况。

Europe

欧洲

，

Asia

亚洲

, and

，以及

South America

南美洲

. The study population reflects real-world practice, with 74.2% of patients presenting with claudication and 25.8% with chronic limb-threatening ischemia (CLTI). The primary endpoint—freedom from CD-TLR at 12 months—was consistently high: 91.1% in the overall population, 91.3% in claudicants, and 90.3% in CLTI patients.

研究人群反映了真实世界的情况，其中74.2%的患者表现为间歇性跛行，25.8%的患者表现为慢性威胁肢体的缺血（CLTI）。主要终点——12个月时无CD-TLR（临床驱动的目标病变血运重建）——始终保持在较高水平：总体人群中为91.1%，间歇性跛行患者中为91.3%，CLTI患者中为90.3%。

Clinical improvements were seen across the patient cohorts with 88.1% of patients improving by at least one Rutherford category..

在患者队列中观察到了临床改善，其中88.1%的患者至少改善了一个鲁瑟福分类。

'Leveraging SELUTION SLR™ DEB with its unique sirolimus MicroReservoir technology delivers unequivocal clinical benefits in complex patient cohorts,' said Dr.

“利用具有独特西罗莫司微储库技术的SELUTION SLR™ DEB可在复杂的患者群体中带来明确的临床益处，”博士说道。

Michael Lichtenberg

迈克尔·利希滕贝格

, Chief of Interventional Angiology at Klinikum Hochsauerland,

，霍赫绍尔兰诊所介入血管科主任，

Germany

德国

, CMO and Director of Vascular Center Clinic,

，首席营销官兼血管中心诊所主任，

Germany

德国

, and Study Principal Investigator. 'These real-world results demonstrate consistent safety and effectiveness in both claudicant and CLTI patients.'

“,以及研究主要负责人。‘这些真实世界的结果表明，在跛行患者和CLTI患者中，安全性和有效性始终保持一致。’”

Drug

药物

Elution, Done Better – Sustained Sirolimus Release Improves Outcomes

洗脱，做得更好——持续的西罗莫司释放改善结果

'At Cordis, our focus is always on advancing therapies that offer meaningful, lasting impact for patients—and these results do exactly that,' said Dr.

“在Cordis，我们的重点始终是推进为患者提供有意义且持久影响的疗法——这些结果正是如此，”博士说道。

George Adams

乔治·亚当斯

, Chief Medical Officer at Cordis. 'The SELUTION SLR™ studies showcase drug elution, done better – sustained sirolimus delivery results in unmatched and durable efficacy, uncompromised safety and consistent robust real-world data across diverse PAD populations. This is the kind of innovation that truly elevates patient care.'.

“Cordis首席医疗官表示：‘SELUTION SLR™ 研究展示了药物释放的优越性——持续的西罗莫司递送带来了无与伦比且持久的疗效、毫不妥协的安全性，以及在不同周围动脉疾病人群中的稳定可靠的真实世界数据。这种创新真正提升了患者护理水平。’”

About Cordis

关于Cordis

Cordis is a global leader in the development and manufacturing of interventional cardiovascular and endovascular technologies. For over 60 years, we have been committed to improving patient lives through innovation, enhanced clinical outcomes, education, and service. Our mission is to be the heart of innovation to transform cardiovascular care..

Cordis是介入性心血管和血管内技术开发与制造的全球领导者。六十多年来，我们一直致力于通过创新、提升临床效果、教育和服务来改善患者的生活。我们的使命是成为创新的核心，推动心血管护理的变革。

For more information about Cordis, please visit

有关 Cordis 的更多信息，请访问

Cordis.com

科迪斯网

and follow Cordis on

并关注Cordis

领英

。

Media Contact:

媒体联系人：

Kelly May