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The Esprit everolimus-eluting scaffold. [Image from the Abbott website]Abbott (NYSE:ABT) today announced data demonstrating the long-term effectiveness of its Esprit BTK drug-eluting stent.
Esprit依维莫司洗脱支架。[图片来自雅培网站]雅培(纽约证券交易所代码:ABT)今天宣布了数据,证明了其Esprit BTK药物洗脱支架的长期有效性。
The everolimus-eluting resorbable scaffold system treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. The first-of-its-kind stent provides support to the vessel until it’s strong enough to remain open on its own..
依维莫司洗脱可再吸收支架系统治疗膝下慢性肢体缺血(CLTI)(BTK)。雅培设计它是为了保持动脉开放,并在完全溶解之前输送依维莫司以支持血管愈合。这种类型的第一个支架为血管提供支撑,直到它足够强大,可以自己保持开放状态。。
Esprit picked up FDA clearance in April.
Esprit在4月份获得了FDA的批准。
Abbott’s LIFE-BTK evaluated Esprit in the treatment of patients with the most severe form of peripheral artery disease (PAD) BTK. The company reported two-year data looking at more than 260 people worldwide at VIVA 2024 in Las Vegas.
雅培的LIFE-BTK评估了Esprit治疗最严重形式的外周动脉疾病(PAD)BTK患者的疗效。该公司报告称,在拉斯维加斯举行的2024年万岁大会上,全球有260多人参加了为期两年的数据调查。
LIFE-BTK evaluated whether Esprit BTK could offer greater long-term benefits than balloon angioplasty, a common treatment for PAD. Outcomes showed sustained benefits for Esprit BTK over balloon angioplasty, the standard of care. Investigators also reported fewer repeat procedures at two years.
LIFE-BTK评估了Esprit BTK是否比球囊血管成形术(PAD的常见治疗方法)提供更大的长期益处。结果显示,Esprit BTK优于球囊血管成形术(标准治疗)。调查人员还报告说,两年内重复手术的次数较少。
Abbott said the data also showcased strong two-year results when compared to other therapies. Its primary efficacy endpoint looked at the ability of the vessel to stay open and lengthen the time until another intervention is needed.
雅培表示,与其他疗法相比,这些数据也显示出两年的强劲结果。其主要疗效终点是观察血管保持开放并延长时间直至需要再次干预的能力。
In total, 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months. The study showed sustained efficacy at 24 months, demonstrating long-term durability in reducing reclosures and helping the vessel stay open.
总的来说,Esprit BTK组90.3%的患者在24个月时不需要再次干预。该研究显示在24个月时持续有效,证明了在减少重合闸和帮助船舶保持开放方面的长期耐久性。
Compared to balloon angioplasty, those treated with Esprit BTK had significantly greater freedom from CLTI, a severe form of PAD. This represented the primary efficacy clinical event, with the Esprit group registering a freedom rate of 61.5% vs. 32.8%. At one year, the trial’s powered secondary endpoints revealed that Esprit BTK had a higher rate of reducing vessel re-narrowing (35.2% improvement)..
与球囊血管成形术相比,用Esprit BTK治疗的患者明显不受CLTI(一种严重的PAD形式)的影响。这代表了主要的疗效临床事件,Esprit组的自由率分别为61.5%和32.8%。一年后,该试验的动力次要终点显示,Esprit BTK减少血管再狭窄的比率更高(改善35.2%)。。
Abbott also launched a post-approval study for Esprit BTK to evaluate its continued safety and effectiveness in a real-world setting. Dr. Bernardino L. Rocha, a ascular surgeon at SSM Health Heart & Vascular Care in Oklahoma City, Oklahoma, enrolled the first patient.
雅培还为Esprit BTK启动了一项批准后研究,以评估其在现实环境中的持续安全性和有效性。俄克拉荷马州俄克拉荷马市SSM Health Heart&Vascular Care的血管外科医生BernardinoL.Rocha博士招募了第一名患者。
“The positive results at two years reinforce Esprit BTK’s potential to revolutionize the treatment of peripheral artery disease below the knee,” said Jennifer Jones-McMeans, DVP of global clinical affairs at Abbott’s vascular business. “We’re proud to be at the forefront of developing innovative treatment options for the millions of people living with PAD.
雅培血管业务全球临床事务高级副总裁詹妮弗·琼斯·麦克米恩(JenniferJones McMeans)表示:“两年的积极成果增强了Esprit BTK彻底改变膝下外周动脉疾病治疗的潜力。”。“我们自豪地站在为数百万PAD患者开发创新治疗方案的前沿。
By eliminating the need for multiple interventions and in some cases, amputation, we’re ultimately helping people live fuller, better lives.”.
通过消除对多种干预措施的需要,在某些情况下,通过截肢,我们最终可以帮助人们过上更充实、更好的生活。”。