7月13日消息-环球医学据悉，一个总部设在东京的Terumo公司的美国子公司Terumo医疗公司的战略业务单位-- Terumo介入系统，已完成在美国招募外周动脉闭塞/狭窄血运重建研究(OSPREY)的受试者，此研究旨在评价MISAGO自扩张支架系统的安全性和有效性。OSPREY是一项单组、多中心、非随机前瞻性的股浅动脉粥样硬化狭窄和闭塞治疗的临床试验，其中包括美国31个中心的200名受试者和日本7个中心100名受试者的临床试验。

作为HBD的试点方案的一部分，这一具有里程碑意义的研究的一个特点是它同时在美国和日本招募受试者，此方案由美国食品与药物管理局、日本的监管机构、总部在日本东京的Terumo公司、总部设在新泽西州萨默塞特的Terumo医疗公司共同合作执行。

HBD旨在这两个重要的世界医疗市场中缩短产品认证之间的差距。“OSPREY是泰尔茂医疗公司的第一个美国在上市前批准（PMA）的设备的临床试验，我们都格外看好其前景。Terumo公司非常感激美国临床研究者提供的巨大的支持，在达到这一具有里程碑意义的HBD的初步阶段帮助我们完成了关键的招募目标”，Terumo公司介入系统和On set医药公司总裁詹姆斯•拉什沃思说。 “OSPREY试验和MISAGO自扩张支架真正实现了我们引进创新技术的三个战略支柱，即创造临床的、经济的和提高生活质量的益处”。

MISAGO自我扩张支架包括一个镍钛合金支架预安装在一个快速交换输送导管系统远端部分。每个支架上有三个不透X线的标记，以帮助确定病灶的准确位置。支架目前正在欧洲销售。（环球医学）
 

原文

Terumo completes patient enrollment in the US for trial

OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery

Singapore: Terumo Interventional Systems, a strategic business unit of Terumo Medical Corporation, a US subsidiary of Tokyo-based Terumo, has completed patient enrollment in the Occlusive/Stenotic Peripheral Artery REvascularization StudY (OSPREY) in the US designed to evaluate the safety and effectiveness of the MISAGO Self-expanding Stent System. OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the superficial femoral artery that included 200 patients in 31 centers in the US and 100 patients in seven centers in Japan.

A unique feature of this landmark study is that it simultaneously enrolled patients in the US and Japan as part of the larger Harmonization by Doing (HBD) pilot program, a cooperative effort led by the US Food & Drug Administration, the Japan's regulatory body, Terumo Corporation, based in Tokyo, Japan, and Terumo Medical Corporation, based in Somerset, New Jersey

The HBD initiative is intended to shorten the gap between product approvals in these two significant world healthcare markets. "OSPREY is Terumo Medical Corporation's first US clinical trial for a premarket approval (PMA) device and we are exceptionally pleased with its progress. Terumo is greatly appreciative of the tremendous support given by our US clinical investigators, which helped us meet the critical enrollment goal in this landmark HBD initiative," said James Rushworth, President of Terumo Interventional Systems and Onset Medical Corporation. "The OSPREY trial and the MISAGO Stent truly speak to our three strategic pillars of introducing innovative technologies that create Clinical, Economic, and Quality of Life Benefits."

The MISAGO self-expanding stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.

      相关链接：

http://www.biospectrumasia.com/biospectrum/news/2280/terumo-completes-patient-enrollment-us-trial

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