美敦力公司公布了支架治疗外周动脉疾病的临床研究

Medtronic Announces Clinical Trial Of Stent For Peripheral Arterial Disease

美敦力公司公布了支架治疗外周动脉疾病的临床研究

符合其对未满足治疗需求患者的承诺，美敦力公司今天公布了FDA批准的完全自扩张式支架治疗股浅动脉(SFA)的外周动脉疾病(PAD)的临床研究首次入选的情况。

根据外周动脉疾病联盟的统计，在美国，虽然很多患者没有意识到他们的病情也没意识到疾病的严重程度，但下肢PAD影响到了大约800万人。PAD联盟报道说，PAD患者增加了2-6倍的心血管病死亡率，并且也明显增加了截肢、残疾和生活质量下降的风险。

该研究的主要负责人，戴维斯加州大学血管中心John Laird博士说：“美敦力公司的治疗外周动脉疾病的临床研究计划表明了其帮助医生以及患者的坚定决心”。通过目前正在进行之中三项临床研究，美敦力公司正和全世界医生一起合作来评价治疗PAD支架的安全性和有效性。 获得了FDA批准的研究器械豁免(IDE)，SFA是一项前瞻性多中心无对照研究，计划在全球30个中心入选178名受试者。SFA研究入选的是有症状的PAD患者，研究主要终点为12个月时的主要不良事件(MAEs)和支架的通畅性。

2008年还注册了其他二项PAD研究，用以评价美敦力支架治疗髂动脉病变：

完全自扩张式支架目前正在被IDE认可的临床研究来评价，该研究主要治疗有症状和无症状的PAD受试者的髂动脉病变。完全自扩张式支架治疗髂动脉疾病的研究是一项非随机前瞻性研究，该研究计划入选60名受试者。主要研究终点是30天和9个月时的MAEs。通过12个美国研究中心的参与，入选工作很早就得以完成。

相似的，球囊扩张式Assurant Cobalt支架目前正在被IDE认可的临床研究来评价，该研究主要治疗有症状的PAD受试者的髂动脉病变。该研究于2008年10月启动，是一项非随机前瞻非对照性研究，计划在美国的20个中心入选123名受试者。研究的主要终点为9个月时的MAEs。

关于美敦力公司

美敦力公司总部位于美国明尼阿波利斯市，是全球领先的医疗科技公司—减轻病痛，恢复健康，延长全世界数以百万计人的寿命。

(《医心评论》编辑：陆卫 翻译  毛新罡 校对））

来源：www.medicalnews.com

Medtronic Announces Clinical Trial Of Stent For Peripheral Arterial Disease

Consistent with its commitment to addressing unmet patient needs, Medtronic, Inc. (NYSE: MDT), today announced the first enrollment in the company’s FDA-approved clinical trial of its self-expanding (SE) Complete SE stent for the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA).

According to the Peripheral Arterial Disease Coalition, PAD of the lower extremities affects approximately eight million people in the United States, although many patients are unaware of their condition or the seriousness of it. PAD patients have a two- to six-fold increase in cardiovascular mortality and a significantly increased risk of amputation, disability and diminished quality of life, the PAD Coalition reports.

"Medtronic’s clinical research program for peripheral arterial disease demonstrates a strong commitment to helping physicians and their patients," said the study’s principal investigator, Dr. John Laird of the Vascular Center at the University of California (UC) Davis. "Through three clinical trials currently underway, Medtronic is partnering with physicians worldwide to evaluate the safety and efficacy of its stents in the treatment of PAD."

 Approved by the FDA under an investigational device exemption (IDE), the SFA study is a prospective, multicenter, single-arm trial planned to enroll 178 subjects at up to 30 sites globally. Enrolling patients with symptomatic PAD in the SFA, the study has primary endpoints of major adverse events (MAEs) and patency of the stent at 12 months.

Enrollment in two other PAD studies to evaluate the treatment of iliac artery lesions with Medtronic stents also began in 2008:

The Complete SE stent is currently being evaluated in an IDE-approved clinical trial for use in the treatment of iliac artery lesions in subjects with symptomatic and asymptomatic PAD. The Complete SE Iliac Registry is a non-randomized, prospective study designed to enroll 60 subjects. The primary study endpoints are MAEs at 30 days and nine months. With 12 U.S. sites participating, enrollment is early complete.

Similarly, the balloon-expandable Assurant Cobalt stent is currently being evaluated in an IDE-approved clinical trial as a treatment for iliac artery lesions in subjects with symptomatic PAD. Initiated in October 2008, the study is a non-randomized, prospective, single-arm trial with an enrollment target of 123 subjects at 20 U.S. sites. The primary endpoint of the study is MAEs at nine months.

About Medtronic
Medtronic, Inc., headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world.

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