Medtronic, the global leader in healthcare technology, today announced the VenaSeal Spectrum Program primary endpoints and 30-day modified Aberdeen Varicose Vein Questionnaire (AVVQ) results on the use of the VenaSeal™ closure system compared to surgical stripping (SS) and endothermal ablation (ETA) for the treatment of superficial venous disease.

全球医疗技术领导者美敦力今天宣布了VenaSeal Spectrum计划的主要终点和30天改良阿伯丁静脉曲张问卷（AVVQ）结果，与手术剥离（SS）和吸热消融（ETA）相比，使用VenaSeal™闭合系统治疗浅表静脉疾病。

The results, which were presented today at Charing Cross International Symposium as a podium first presentation, also include safety and anatomic closure data through six months..

今天在Charing Cross国际研讨会上作为领奖台首次展示的结果还包括六个月的安全性和解剖闭合数据。。

“The initial results of two of the three studies in the VenaSeal Spectrum Program reinforce the safety and effectiveness of the VenaSeal system as compared to current standards of care,” said John Laird, M.D., chief medical officer for the Peripheral Vascular Health business in the Medtronic Cardiovascular portfolio.

美敦力心血管投资组合外周血管健康业务首席医疗官约翰·莱尔德医学博士说：“与目前的护理标准相比，静脉频谱计划的三项研究中有两项的初步结果加强了静脉系统的安全性和有效性。”。

“As one of the largest clinical programs in the venous space, the Spectrum Program demonstrates the Medtronic commitment to bring forward data to inform treatment decisions and advance the field of patient-centered research.”.

“作为静脉领域最大的临床项目之一，Spectrum项目证明了美敦力致力于提供数据，为治疗决策提供信息，并推进以患者为中心的研究领域。”。

The VenaSeal Spectrum Program is one of the largest and most innovative clinical programs in the treatment of venous disease. The program includes two randomized controlled clinical trials (RCTs) investigating the VenaSeal system versus SS and ETA and a single-arm study focused on venous leg ulcers.

静脉频谱计划是治疗静脉疾病的最大和最具创新性的临床计划之一。该计划包括两项随机对照临床试验（RCT），研究静脉系统与SS和ETA的关系，以及一项针对静脉性腿部溃疡的单臂研究。

Two of the primary endpoints of the RCTs are measured using the Venous Treatment Satisfaction Questionnaire (VenousTSQ), a novel tool that measures patient satisfaction with the treatment received for superficial venous disease. Another primary endpoint of the study is the elimination of truncal reflux, which represents the percentage of diseased vein treated..

随机对照试验的两个主要终点是使用静脉治疗满意度问卷（VenousTSQ）测量的，这是一种测量患者对浅静脉疾病治疗满意度的新工具。该研究的另一个主要终点是消除躯干反流，这代表了患病静脉治疗的百分比。。

“The 30-day and six-month outcomes for both the surgical stripping and ETA studies are an important addition to the global clinical evidence for the VenaSeal system,” said Prof. Manj Gohel, M.D., primary investigator of the VenaSeal Spectrum Program and consultant vascular surgeon and honorary senior lecturer, Cambridge University Hospitals, Imperial College (Cambridge, U.K.).

“手术剥离和ETA研究的30天和6个月的结果是静脉系统全球临床证据的重要补充，”Manj Gohel教授说，他是静脉频谱计划的主要研究者和顾问血管外科医生，也是帝国理工学院剑桥大学医院荣誉高级讲师。

“This new, multi-center, randomized evidence about the minimally invasive VenaSeal system will provide the clinical community with key data to inform treatment decisions for patients with superficial venous disease.”.

“这项关于微创静脉系统的新的多中心随机证据将为临床社区提供关键数据，为浅静脉疾病患者的治疗决策提供信息。”。

The VenaSeal system demonstrated superior peri-procedural patient satisfaction compared with surgical stripping, one of the primary endpoints in the RCTs. The other primary endpoint outcomes were not met. AVVQ results, a conventional endpoint, were trending in favor of the VenaSeal system at 30 days.

与手术剥离相比，VenaSeal系统表现出更好的围手术期患者满意度，这是随机对照试验的主要终点之一。其他主要终点结果未得到满足。AVVQ结果是一个常规终点，在30天时有利于静脉系统。

Anatomic closure rate through six months was found to be comparable with the current standards of care for both studies. While the VenaSeal system was not able to demonstrate superiority across all endpoints, this minimally invasive procedure performed comparably to the current standards of care..

发现六个月的解剖闭合率与两项研究的当前护理标准相当。虽然静脉系统无法在所有终点显示出优越性，但这种微创手术的表现与当前的护理标准相当。。

VenaSeal system vs. SS RCT (30-day outcomes)

VenaSeal系统与SS RCT（30天结果）

VenousTSQ peri-procedural: The primary endpoint was met, demonstrating superior patient satisfaction for the VenaSeal system peri-procedurally (p=0.0013, alpha=0.025)

VenousTSQ围手术期：主要终点得到满足，表明围手术期患者对静脉系统的满意度更高（p=0.0013，alpha=0.025）

VenousTSQ post-procedural (30 days): The primary endpoint was not met; participants were similarly satisfied post-procedurally (p=0.0504, alpha=0.05)

VenousTSQ术后（30天）：主要终点未达到；参与者在程序后也同样满意（p=0.0504，alpha=0.05）

Elimination of Truncal Reflux*: The primary endpoint was not powered for testing due to early study closure; VenaSeal system performed similarly as SS (p=n/a, alpha=n/a)

消除躯干反流*：由于早期研究结束，主要终点无法进行测试；静脉系统的表现与SS相似（p=n/a，alpha=n/a）

Modified AVVQ: The secondary endpoint was trending in favor of the VenaSeal system at 30-days (p=0.0039, alpha=n/a)

改良AVVQ：次要终点在30天时有利于静脉系统（p=0.0039，alpha=n/a）

VenaSeal system vs. ETA RCT (30-day outcomes)

VenaSeal系统与ETA RCT（30天结果）

VenousTSQ peri-procedural: The primary endpoint was not met; participants were similarly satisfied peri-procedurally (p=0.0260, alpha=0.0167)

VenousTSQ围手术期：主要终点未达到；参与者在围手术期也同样满意（p=0.0260，alpha=0.0167）

VenousTSQ post-procedural (30 days): The primary endpoint was not met; participants were similarly satisfied post-procedurally (p=0.7954, alpha=0.05)

VenousTSQ术后（30天）：主要终点未达到；参与者在程序后也同样满意（p=0.7954，alpha=0.05）

Elimination of Truncal Reflux*: The primary endpoint was not met; VenaSeal system performed similarly as ETA (p=0.0858, alpha=0.025)

消除躯干反流*：未达到主要终点；VenaSeal系统的表现与ETA相似（p=0.0858，alpha=0.025）

Modified AVVQ: The secondary endpoint was trending in favor of the VenaSeal system at 30-days (p=0.0076, alpha=n/a)

改良AVVQ：次要终点在30天时有利于静脉系统（p=0.0076，alpha=n/a）

In addition, six-month data from both studies reinforce that the VenaSeal system has a safety profile consistent with peer-reviewed reports from other clinical studies1 showing low incidence of serious adverse events and VenaSeal system-specific complications occurring at low rates, all within the ranges found in peer-reviewed literature. .

此外，两项研究的六个月数据都证实，静脉系统的安全性与其他临床研究的同行评审报告一致，1显示严重不良事件发生率低，静脉系统特异性并发症发生率低，均在同行评审文献中发现的范围内。。

Anatomic closure through six months in the VenaSeal system treated population was non-inferior to surgical stripping (97.9% vs 92.9%; P-value = 0.00041). Anatomic closure was not formally tested (to control for multiple hypothesis testing) in the VenaSeal system vs ETA study, but similar effectiveness in each arm was observed (93.1% vs 93.6%, respectively). .

在接受静脉系统治疗的人群中，六个月的解剖闭合不劣于手术剥离（97.9%比92.9%；P值=0.00041）。在VenaSeal system vs ETA研究中，解剖闭合未经过正式测试（以控制多重假设检验），但观察到每只手臂的有效性相似（分别为93.1%和93.6%）。。

“The Spectrum Program is expanding the way we look at the treatment of superficial venous disease by testing novel patient-centric endpoints,” said Dr. Kathleen Gibson, M.D., primary investigator of the VenaSeal Spectrum Program and vascular surgeon, Lake Washington Vascular Surgeons (Bellevue, Wash., U.S.).

“Spectrum计划正在通过测试新的以患者为中心的终点来扩大我们对浅静脉疾病治疗的看法，”Kathleen Gibson博士说，他是VenaSeal Spectrum计划的主要研究者和华盛顿湖血管外科医生（美国华盛顿州贝尔维尤）的血管外科医生。

“To gather the most robust data possible from this study, the primary endpoints are joined by a comprehensive set of secondary endpoints using traditional measurements, which we look forward to sharing in the future.”.

“为了从这项研究中收集尽可能强大的数据，主要终点通过使用传统测量的一组全面的次要终点连接起来，我们期待着在未来分享。”。

The Spectrum Program will follow up with patients over multiple years for select endpoints, expanding the body of long-term evidence for the VenaSeal system. Additional data will be released as it becomes available.

Spectrum计划将对患者进行多年的随访，以选择终点，扩大静脉系统的长期证据。其他数据将在可用时发布。