MIAMI LAKES, Fla., June 18, 2024 /PRNewswire/ -- Cordis, a global leader in the development and manufacturing of interventional cardiovascular and endovascular technology, today announces positive 24-month results from the SELUTION SFA Japan Trial. The prospective, multi-center, single arm trial is designed to assess the safety and efficacy of SELUTION SLR™ Drug-Eluting Balloon (DEB) for the endovascular therapy of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA).

佛罗里达州迈阿密湖，2024年6月18日/PRNewswire/--介入性心血管和血管内技术开发和制造的全球领导者Cordis今天宣布SELUTION SFA Japan试验的24个月积极结果。这项前瞻性，多中心，单臂试验旨在评估SELUTION SLR™药物洗脱球囊（DEB）用于血管内治疗股浅动脉（SFA）和腘动脉（PA）新生和非支架再狭窄病变的安全性和有效性。

The findings were presented at the Japan Endovascular Treatment Conference (JET) 2024..

研究结果发表在2024年日本血管内治疗会议（JET）上。。

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'The SELUTION SLR™ DEB outcomes demonstrate patient benefits that are sustained out to 24 months and can match proven paclitaxel DCB performance in a complex patient population,' said Dr. Osamu Iida, Osaka Police Hospital Cardiovascular Division, Osaka, Japan. 'These are promising results that build confidence in Limus drug-eluting balloons being a safe and effective option for SFA treatment while avoiding any paclitaxel related concerns.'.

日本大阪警察医院心血管科Osamu Iida博士说：“SELUTION SLR™DEB的结果表明，患者的益处可以持续24个月，并且可以与复杂患者群体中已证实的紫杉醇DCB表现相匹配。”这些有希望的结果建立了对Limus药物洗脱气球的信心，这是SFA治疗的安全有效选择，同时避免了任何与紫杉醇相关的问题。”。

The long-term follow-up of SELUTION SLR™ DEB confirmed efficient sirolimus drug transfer and retention with safety and efficacy sustained through 24 months in a complex population that included 60.3% diabetics, mean lesion length of 127 mm, 17.2% total occlusions, and 47.8% involvement of the popliteal..

SELUTION SLR™DEB的长期随访证实，在包括60.3%糖尿病患者，平均病变长度127 mm，17.2%总闭塞和47.8%腘窝受累的复杂人群中，西罗莫司药物的有效转移和保留持续了24个月，安全有效。。

At 24 months, SELUTION SLR™ DEB delivered primary patency of 83.0% and CD-TLR of 95.4% achieving best in class efficacy results without compromise.

在24个月时，SELUTION SLR™DEB的主要通畅率为83.0%，CD-TLR为95.4%，达到了同类最佳的疗效结果。

The SELUTION SFA Japan trial results demonstrate consistency of the SELUTION SLR™ DEB in being a safe and effective treatment option for femoropopliteal disease.

SELUTION SFA Japan试验结果表明，SELUTION SLR™DEB是一种安全有效的股腘疾病治疗选择。

'The SELUTION SFA Japan trial continues to build confidence in the SELUTION SLR™ DEB technology. The SELUTION SLR™ DEB delivers some of the highest patency rates amongst SFA paclitaxel DCB studies and differentiates from other Limus-based devices. The ability to achieve durable clinical results in a challenging patient population provides clinicians a solution that will offer value to real world patients,' said George Adams, M.D.

“SELUTION SFA日本试验继续建立对SELUTION SLR™DEB技术的信心。SELUTION SLR™DEB在SFA紫杉醇DCB研究中提供了一些最高的通畅率，并与其他基于Limus的设备有所不同。医学博士乔治·亚当斯（GeorgeAdams）说，在具有挑战性的患者群体中取得持久临床结果的能力为临床医生提供了一种解决方案，将为现实世界的患者提供价值。

and Chief Medical Officer at Cordis. 'We are excited for the evolution of patient care and to be leading that journey by expanding access to SELUTION SLR™ DEB.'Cordis is committed to generating coronary and peripheral clinical evidence that changes the standard of care. The SELUTION SFA Japan trial is one of the first of several large trials in the SELUTION SLR™ DEB clinical trial portfolio.

以及Cordis的首席医疗官。”我们对患者护理的发展感到兴奋，并通过扩大对SELUTION SLR™DEB的访问来引领这一旅程。”Cordis致力于产生改变护理标准的冠状动脉和外周临床证据。SELUTION SFA Japan试验是SELUTION SLR™DEB临床试验组合中首批大型试验之一。

Long term results validate previous clinical experience and builds confidence and excitement for data to come from four major randomized controlled trials and one real world registry data sets currently underway across coronary, superficial femoral artery and below the knee arteries.About SELUTION SLR ™ DEBSELUTION SLR™ DEB uses 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.

长期结果验证了以前的临床经验，并为来自四项主要随机对照试验的数据和目前正在进行的冠状动脉，股浅动脉和膝下动脉的一个真实世界登记数据集建立了信心和兴奋。关于SELUTION SLR™DEBSELUTION SLR™DEB使用含有与抗再狭窄药物西罗莫司混合的可生物降解聚合物混合物的微贮器，作为血管成形术球囊表面的涂层。

These MicroReservoirs are designed to provide controlled and sustained release of the drug. The proprietary CELL ADHERENT TECHNOLOGY (CAT)™ enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.SELUTION SLR™ Drug-Eluting Balloon coronary, SFA, and BTK platforms are commercially available in Europe, the Middle East, and several markets across Asia and Lati.

这些微储库旨在提供药物的受控和持续释放。专有的细胞粘附技术（CAT）™使微储液罐能够涂覆在气球上，并在通过气球膨胀输送时有效转移以粘附在血管腔上。SELUTION SLR™药物洗脱球囊冠状动脉，SFA和BTK平台可在欧洲，中东以及亚洲和拉丁美洲的几个市场上买到。