MIAMI LAKES, Fla., Oct. 24, 2023 /PRNewswire/ -- Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technology, has announced completion of patient enrollment in SUCCESS PTA, its large post-market study with the SELUTION SLR™ Drug-Eluting Balloon (DEB) for the treatment of patients with peripheral artery disease (PAD).

佛罗里达州迈阿密湖，2023年10月24日/PRNewswire/-Cordis是介入性心血管和血管内技术开发和制造的全球领导者，已宣布完成PTA患者入选，PTA是其大型上市后研究与SELUTION SLR™ 药物洗脱球囊（DEB）用于治疗外周动脉疾病（PAD）患者。

SELUTION SLR™ DEB is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to that of a drug-eluting stent (DES)..

选择单反™ DEB是一种新型西罗莫司洗脱球囊，可提供药物的受控持续释放，类似于药物洗脱支架（DES）。。

The objective of the study is to collect 'real-world' safety, efficacy, health economics and patient reported quality-of-life data in over 700 patients with PAD treated with SELUTION SLR™ DEB. It is a single arm all-comers study including all lower limb indications (SFA; BTK; Foot) and will cover at least 50 sites in Europe, Asia, and South America.

本研究的目的是收集700多名使用SELUTION SLR治疗的PAD患者的“现实世界”安全性，有效性，卫生经济学和患者报告的生活质量数据™ 德布。这是一项单臂全方位研究，包括所有下肢适应症（SFA；BTK；Foot），将涵盖欧洲，亚洲和南美洲至少50个地点。

Patients will be followed-up at 30 days; six months; then every year out to five years..

患者将在30天后随访；六个月；然后每年都要到五年。。

The primary endpoint of the study is Clinically Driven Target Lesion Revascularization (CD-TLR) at 12 months. Secondary endpoints include device success and procedure success; Major Adverse Limb Events (MALE); and Target Limb Revascularization (TLR).

该研究的主要终点是12个月时临床驱动的靶病变血运重建（CD-TLR）。次要终点包括设备成功和程序成功；主要不良肢体事件（男性）；和目标肢体血运重建（TLR）。

Data from the SUCCESS PTA Study will be part of the clinical evidence supporting CE Mark renewal under the European Medical Device Directive (MDR).

根据欧洲医疗器械指令（MDR），SUCCESS PTA研究的数据将成为支持CE标志更新的临床证据的一部分。

'Given the impressive performance of this novel device in earlier studies, we are very excited to see how SELUTION SLR™ DEB will perform in a larger group of patients in a real-world setting,' commented the study's Principal Investigator Michael Lichtenberg, Arnsberg, Germany.

'鉴于这种新型设备在早期研究中的令人印象深刻的表现，我们非常高兴地看到SELUTION SLR™ 该研究的首席研究员Michael Lichtenberg（德国阿恩斯堡）评论说，DEB将在现实环境中的更多患者中发挥作用。

'This is the largest and most important study we have done for these BTK and SFA patients to date. We are very excited to partner with thought leaders globally to build an extensive compendium of clinical evidence that supports our groundbreaking SELUTION SLR™ DEB technology,' commented Shar Matin, CEO of Cordis. .

'这是迄今为止我们为这些BTK和SFA患者所做的最大和最重要的研究。我们非常高兴与全球思想领袖合作，建立广泛的临床证据汇编，支持我们开创性的自我反冲™ DEB technology，“Cordis首席执行官Shar Matin评论道。 .

SELUTION SLR™ DEB was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020.  MedAlliance, acquired by Cordis in October 2023, was the first drug-eluting balloon company to receive FDA Breakthrough Designation status.

选择单反™ DEB于2020年2月获得CE标志批准用于治疗外周动脉疾病，并于2020年5月获得冠状动脉疾病治疗.MedAlliance于2023年10月被Cordis收购，是第一家获得FDA突破性指定的药物洗脱气球公司状态。

In addition to the BTK and superficial femoral artery (SFA) indications for which the company received FDA IDE approval in May and August 2022, SELUTION SLR™ DEB received coronary in-stent restenosis (ISR) IDE approval in October 2022 and IDE approval for de novo coronary artery disease in January 2023..

除了BTK和浅表股动脉（SFA）适应症，该公司于2022年5月和8月获得FDA IDE批准，SELUTION SLR™DEB于2022年10月获得冠状动脉支架内再狭窄（ISR）IDE批准，并于2023年1月获得IDE批准用于从头冠状动脉疾病。。

Subsequent to achieving IDE Status, three FDA studies involving SELUTION SLR™ DEB are currently enrolling with a fourth, involving patients with coronary de novo artery disease, planned to start shortly. The latter will complement the substantial experience gained with the ground-breaking SELUTION DeNovo Trial in Europe, which has now enrolled over 1,660 patients, roughly half of the planned 3,326 patients.

在达到IDE状态之后，FDA进行了三项涉及选择SLR的研究™DEB目前正在招募第四名，涉及冠状动脉疾病患者，计划很快开始。后者将补充在欧洲开创性的SELUTION DeNovo试验中获得的实质性经验，该试验现已招募了1660多名患者，约占计划的3326名患者的一半。

SELUTION DeNovo Trial compares the treatment strategy using SELUTION SLR™ DEB versus any limus drug-eluting stent [DES] [ClinicalTrials.gov Identifier: NCT04859985]. This study is designed to change medical practice, as the majority of de novo coronary lesions are currently treated with a permanent metallic stent..

SELUTION DeNovo试验比较使用SELUTION SLR的治疗策略™ DEB与任何limus药物洗脱支架[DES][ClinicalTrials.gov标识符：NCT04859985]。这项研究旨在改变医疗实践，因为大多数新生冠状动脉病变目前都用永久性金属支架治疗。。

SELUTION SLR™ DEB's unique technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs have been designed to provide controlled and sustained release of the drug for up to 90 days.

选择单反™DEB独特的技术涉及微孔库，其中包含可生物降解聚合物的混合物，与抗再狭窄药物西罗莫司混合，用作血管成形术球囊表面的涂层。这些微储库被设计用于提供长达90天的药物的受控和持续释放。

Cordis' proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon..

Cordis的专有猫™ （细胞粘附技术）使微容器能够涂覆到球囊上，并且当通过球囊的膨胀递送时有效地转移到粘附到血管腔上。。

SELUTION SLR™ DEB is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 40,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.

选择单反™ DEB可在欧洲，亚洲，中东和美洲（美国以外）以及CE标志认可的大多数其他国家/地区销售。在常规临床实践中或作为冠状动脉临床试验的一部分，已有超过40000个单位用于患者治疗。

About Cordis

关于Cordis

Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and minimally invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world.

Cordis是介入血管技术开发和制造领域的全球领导者，拥有60多年开创性突破性心血管技术治疗数百万患者的历史。凭借临床敏锐度，培训和服务声誉，Cordis在高质量和微创心血管产品方面建立了创新遗产，并在全球70多个国家建立了强大的全球足迹。

Cordis is backed by private equity firms Hellman & Friedman and KKR. For more information, visit www.cordis.com..

Cordis得到了私募股权公司Hellman＆Friedman和KKR的支持。欲了解更多信息，请访问www.cordis.com。。

Media Contact:Chris BinghamVice President, Global Marketing & Strategy[email protected]m. 512-569-8652

媒体联系：全球营销与战略Chris BinghamVice总裁[电子邮件保护]m。512-569-8652

SOURCE Cordis

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