2013-03-13
 

该协议扩大了晚期外周动脉疾病的治疗选择

新泽西州BRIDGEWATER --(美国商业资讯)--血管介入技术方面的全球领导者Cordis Corporation今天宣布已完成对Flexible Stenting Solutions, Inc.的收购，这是一家开发创新的可弯曲外周动脉、静脉和胆管支架方面的领导者。

Cordis目前在全球推广S.M.A.R.T.^®血管支架。Flexible Stenting Solutions的FlexStent^®自扩张支架系统加入后，Cordis有机会演进S.M.A.R.T.^®支架平台，以满足外周动脉疾病(PAD)治疗中未获满足的需求。它同时延伸了该公司将治疗应用拓展至膝盖以下和静脉介入的潜力。单在欧洲和北美，罹患PAD的人士估计就有2700万。

Cordis Corporation公司集团主席Shlomi Nachman说："Cordis不断寻找机会来壮大它扩张中的微创治疗选择产品阵容，以满足全球血管疾病患者的需求。通过此次收购，Cordis能够为临床医生提供更多的选择，来满足他们不断演进的治疗需求，同时能加强我们在血管疾病治疗中的领先地位。"

此次收购标志着该公司在加强其在血管内市场地位的战略中取得的又一里程碑。Cordis的S.M.A.R.T.^®支架近期获得股浅动脉(SFA)和近端腘动脉(PPA)适应证，这是唯一在美国获得髂动脉、SFA和PPA动脉适应证的支架。此外，Cordis提供市场领先的血管内技术平台，包括经皮腔内血管成形术球囊和慢性全腔阻塞穿通器械。

德国Bad Krozingen市Universitaets-Herzzentrum, Freiburg - Bad Krozingen大学心脏中心血管科主任、教授Thomas Zeller博士说："FlexStent^®系统是一种有前景的平台，旨在优化灵活性、抗折性和径向强度以及置放时的可预见性。我们期待着拓展我们使用这一新技术平台的经验。"

2009年1月，FlexStent^®系统获得欧盟CE标志，获准用于治疗血管疾病（髂动脉、SFA和腘动脉）。2009年9月，该器械获得美国食品药品管理局(FDA)的510(k)核准，用于恶性肿瘤相关的胆道缩窄的姑息治疗。另外，FlexStent^®系统治疗SFA粥样硬化或SFA病患者的安全性和有效性正在一项研究性器械豁免(IDE)研究中接受评估。¹ 该项开放试验的数据预计将在美国用于支持一项扩大适应证以治疗SFA病的上市前核准(PMA)申报。

纽约心血管研究基金会血管内科主任William A. Gray, MD说："我们很高兴有更多机会了解FlexStent^®系统技术及其在美国患者现有核准适应证以外的潜在治疗应用。"

此次收购的条款未披露。Gray医生和Thomas Zeller教授收取了 Cordis的咨询劳务费。

关于外周动脉疾病

外周动脉疾病(PAD)病因是脂质堆积、粘附在动脉内壁，此过程称为粥样硬化。堆积物引起动脉内壁增厚、动脉腔狭窄、关键组织和器官的血流供应受限。常见的受累动脉位于腿部、手臂、颈部和肾脏。

关于Cordis Corporation

Cordis Corporation是强生集团公司成员，是世界领先的血管介入技术开发和制造商。Cordis通过公司的创新和研发，与世界各地的医生合作，治疗成数百万的血管疾病患者。有关Cordis Corporation的进一步信息，请访问www.cordis.com。

1. FlexStent^®系统仅在美国获准用于治疗SFA粥样硬化或SFA病患者的研究性用途。对于这一研究性用途，该产品未在美国进入商业化销售。FlexStent^®系统用于恶性肿瘤相关的胆道缩窄的姑息治疗的申报于2009年9月获得510(k)核准，在美国进入商业化销售。

本新闻稿包含《1995年美国私人证券诉讼改革法案》中所定义的"前瞻性陈述"。谨此提醒读者不应依赖于这些前瞻性陈述。这些陈述基于目前对未来事件的预期。如果基础假设证明是不精确的，或未知风险或不确定因素成为现实，实际结果可能与Cordis Corporation和/或强生的预期和预测有实质性的差异。这些风险和不确定因素包括但不限于：行业总体情况和竞争；经济因素，例如利率和货币兑换率波动；竞争者取得技术进步、新产品和专利；新产品开发中固有的挑战，包括获得监管部门的核准；对专利权的挑战；健康保健产品和服务的采购方的行为和开支模式变化或财务压力；政府法律和法规变化和国内外健康保健改革；健康保健成本控制的趋势；政府部门对健康保健行业的管控不断从严；制造困难或延误；以及对产品有效性或安全性的担忧导致产品召回或监管行动。有关这些风险、不确定因素和其他因素的详细清单及描述可查询强生公司截至2012年12月30日财年的10-K 表年报的第99条。有关此份10-K表的副本及后续文档，可在线访问www.sec.gov、www.jnj.com或向强生公司索取。无论Cordis Corporation还是强生公司均不承担因新信息或未来事件或发展的结果而更新这些前瞻性陈述的义务。

免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。

联系方式：

Cordis Corporation
Sandy Pound
908-218-2720 办公室
908-432-2829 手机
spound@its.jnj.com

 

Cordis Acquires Flexible Stenting Solutions, Inc.

Agreement Expands Treatment Options for Advanced Peripheral Artery Disease

BRIDGEWATER, N.J.--(BUSINESS WIRE)-- Cordis Corporation, a worldwide leader in the development of interventional vascular technology, today announced it has completed the acquisition of Flexible Stenting Solutions, Inc., a leading developer of innovative flexible peripheral arterial, venous and biliary stents.

Currently, Cordis markets the S.M.A.R.T.^® Vascular Stent worldwide. The addition of Flexible Stenting Solutions' FlexStent^® Self Expanding Stent System provides Cordis with the opportunity to evolve the S.M.A.R.T.^® Stent platform to address unmet needs in the treatment of peripheral artery disease (PAD). It also extends the company's potential to expand therapeutic applications into below-the-knee and venous interventions. An estimated 27 million people in Europe and North America alone suffer from PAD.

"Cordis continues to identify opportunities to enhance its expanding portfolio of less invasive treatment options to address the needs of patients suffering from vascular disease worldwide," said  Shlomi Nachman, Company Group Chairman, Cordis Corporation. "This acquisition will enable Cordis to provide clinicians more options to meet their evolving therapeutic needs and to strengthen our leadership position in the treatment of vascular disease."

This acquisition marks another milestone in the company's strategy to strengthen its position in the endovascular market. Recently Cordis received superficial femoral artery (SFA) and proximal popliteal artery (PPA) indications for the S.M.A.R.T.^® Stent, the only stent approved in the U.S. for iliac, SFA and PPA vascular indications. In addition, Cordis offers market-leading endovascular technology platforms including percutaneous transluminal angioplasty balloons and chronic total occlusion crossing devices.

"The FlexStent^® System is a promising platform designed to optimize flexibility, fracture resistance and radial strength with predictable placement. We look forward to expanding our experience with this new technology platform," said Prof. Dr.  Thomas Zeller, Director Department Angiology at Universitaets-Herzzentrum, Freiburg - Bad Krozingen, Bad Krozingen, Germany.

The FlexStent^® System received European CE Mark approval for the treatment of vascular disease (iliac, SFA and popliteal) in January 2009. In the U.S., the device received 510(k) clearance by the Food and Drug Administration (FDA) for the palliative treatment of biliary strictures associated with malignant tumors in September 2009. The FlexStent^® System is also being evaluated in an Investigational Device Exemption (IDE) study to evaluate its safety and efficacy in the treatment of patients with atherosclerosis in the SFA, or SFA disease. ¹ Data from the OPEN Trial are expected to support a Premarket Approval (PMA) application requesting an expanded indication to treat SFA disease in the U.S.

"We are pleased to have the opportunity to learn more about the FlexStent^® System technology and its potential therapeutic applications for patients in the U.S. beyond currently approved indications," said  William A. Gray, MD, Director of Endovascular Services, Cardiovascular Research Foundation,New York.

Terms of the acquisition were not disclosed. Dr. Gray and Prof. Dr.  Thomas Zeller are compensated for their services as consultants to Cordis.

About Peripheral Artery Disease

Peripheral artery disease (PAD) is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys.

About Cordis Corporation

Cordis Corporation, part of the Johnson & Johnson family of companies, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with physicians worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com.

1. The FlexStent^® System is approved for investigational use only in the United States for the treatment of patients with atherosclerosis in the SFA, or SFA disease. This product is not available for commercial sale in the United States for this investigational use. The FlexStent^® System is available for commercial sale in the United States for the palliative treatment of biliary strictures associated with malignant tumors pursuant to the 510(k) clearance received in September 2009.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Cordis Corporation and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; manufacturing difficulties or delays; and product efficacy or safety concerns resulting in product recalls or regulatory action. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year endedDecember 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request fromJohnson & Johnson. Neither Cordis Corporation nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

Cordis Corporation
Sandy Pound
908-218-2720 office
908-432-2829 mobile
spound@its.jnj.com

Source: Cordis Corporation