(BW)(SORIN-GROUP)(SRN.MI)索林集团（Sorin Group）在欧洲开展多中心BITAC研究；接受这项研究登记的首例患者植入了全球最小的CRT D设备Ovatio CRT

美国商业新闻2006年6月19日巴黎消息——

索林集团（米兰证券交易所：SRN）心律调整（CRM）业务部是心力衰竭血液动力调整领域里的创新领导者，该业务部今天公布了首个在BITAC（CRT-D患者双心室心动过速后果）临床研究中登记的患者。

BITAC研究的目的就是要对心力衰竭患者植入CRT-D设备后对缓慢的心室心动过速（VTs）的影响，以及随后为期两年缓慢的心室心动过速治疗的临床关系进行评估。海德尔堡医学院的Alexander Bauer博士担任这项研究的首要调查人。

对使用植入式心脏除颤器（ICD）的普通患者进行研究的亚分析显示，缓慢的心室心动过速（每分钟心跳低于150次）对那些心室功能不全的患者来说更加普遍，而且会产生更加严重的后果（1）。BITAC研究专门针对了解心力衰竭患者缓慢的心室心动过速的临床关系，并为医师提供更好的洞察力使他们知道如何对CRT-D患者心室性心律失常进行调整。

参与多中心BITAC研究的患者均患有重度心力衰竭，他们都面临很大的心脏性猝死（SCD）风险，在这种情况下，患者心脏可能会突然或出乎意料地停止跳动。

心力衰竭就是心脏无法泵出足够的血液来满足身体需要。在欧洲，心力衰竭患者达1000万人（2）。进行心脏起搏的心脏再同步治疗（CRT）设备可刺激心肌以再同步心室收缩，因此提高了心脏泵血效率。

由于心力衰竭患者的心脏性猝死风险比正常人高出9倍，因此把心脏同步治疗与植入式心脏除颤器（CRT-D）结合使用可以挽救这些患者的生命。

在这项研究中登记的首批患者植入了索林集团的Ovatio(TM) CRT，这也是全球最小的CRT-D设备。该设备具有独特的Brady Tachy Overlap (BTO(TM))功能，可为缓慢的心室心动过速患者设置低速率的探测范围，同时在患者锻炼过程中可进行起搏和再同步治疗。

植入手术分别由Carlos Morais博士领导的起搏及心律失常组织里的资深医学副总监Herbert Nagele博士在德国Reinbek的St. Adolf-Stift医院，以及助理心脏病专家及电生理学专家Francisco Madeira博士和助理心脏病专家Pedro Cunha博士在葡萄牙Amadora的Hospital Fernando Da Fonseca实施。

Francisco Madeira博士评论说：“这项重要研究将可以使医师更好地了解对心力衰竭患者缓慢的心室心动过速如何进行调整。它将带来特别的利益，因为迄今为止，在没有结合心脏同步治疗的情况下，技术上的局限性限制了医师对心力衰竭患者缓慢的心室心动过速进行监视和治疗的能力。”

索林集团心律调整业务部总裁Andre-Michel Ballester评论说：“这项研究是索林集团努力把创新技术带给每一位患者的延续。我们的目标是要展示索林对心力衰竭患者缓慢的心室心动过速影响进行监视的独特的BTO功能。”

在欧洲，BITAC研究登记的患者将超过400人。预计，登记工作将于2007年底结束。

索林集团：

索林集团心律调整业务部设计和生产植入式起搏器、植入式心脏除颤器、导线和Holter设备，并在全球范围内进行销售。

索林集团（路透社代码：SORN.MI）是一家开发心脏外科手术医疗技术的全球领导企业，集团为心律紊乱、介入心脏病学以及慢性肾病治疗提供创新疗法。索林集团旗下企业包括：Dideco、CarboMedics、COBE Cardiovascular、Stockert、Mitroflow、ELA Medical、Sorin Biomedica、Bellco和Soludia。索林集团在全球80多个国家拥有分支机构，从业人员超过4700人，为全球5000多家公共和私营医疗中心提供服务。

欲了解更多信息，请访问我们的网站： www.sorin.com 。

参考文献

（1）、Sadoul N.、Mletzko R.、Anselme F. et al。IDEF08缓慢的心室心动过速研究国内亚分析（375名患者）。使用植入式心脏除颤器患者缓慢的心室心动过速的影响及临床关系：国内多中心预期研究。2005年8月16日发行，第946－953页。

（2）Cleland JG、Swedberg K、Follath F et al。欧洲心力衰竭调查项目——对欧洲心力衰竭患者的护理品质调查。第一部分：患者特征及诊断。2003年Eur Heart J杂志第24期，第442－463页。

（3）美国心脏学会。心脏病和中风统计。2005年更新。德克萨斯州达拉斯：美国心脏学会。

联系方式：索林集团（Sorin Group） 全球通讯总监 Martine Konorski, +33-1-46013605 martine.konorski@sorin.com 或者 投资者关系部总监 Marilena Giavara, +44-20-70038730 marilena.giavara@sorin.com 或者 通讯及行业事务部总监 Francesca Caprari, +39-02-6332322 francesca.caprari@sorin.com

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(BW)(SORIN-GROUP)(SRN.MI) Sorin Group Initiates Multi-Center 'BITAC' Study in Europe; First Patient Enrolled in the Study Was Implanted with Ovatio CRT, The World's Smallest CRT D Device

PARIS--(BUSINESS WIRE)--June 19, 2006--

Sorin Group (MIL:SRN) Cardiac Rhythm Management (CRM) Business Unit, an innovative leader in the hemodynamic management of heart failure, announces today first patient enrollment in the BITAC (BIventricular TAchycardias Outcome in CRT-D Patients) clinical study.

The purpose of the BITAC study is to assess the incidence of slow ventricular tachycardias (VTs) in heart failure patients implanted with CRT-D devices, as well as the clinical relevance of treating slow VTs during a 2-year follow-up period. The principal investigator for the study is Dr. Alexander Bauer, University Hospital of Heidelberg.

Sub-analysis of studies performed in a general implantable cardioverter defibrillator (ICD) population has shown that slow VTs (lower than 150 beats per minute) are more prevalent and have more serious consequences in those patients with depressed ventricular function(1). The BITAC study specifically aims to address the clinical relevance of slow VTs in a heart failure population and to offer physicians better insight on how to improve the management of ventricular arrhythmias in CRT-D patients.

Patients included in the multicenter BITAC study have advanced heart failure and are at increased risk of sudden cardiac death (SCD), a condition in which the heart stops suddenly and unexpectedly.

Heart failure, an inability of the heart to pump enough blood to meet the body's needs, affects 10 million Europeans(2). Cardiac resynchronization therapy (CRT) devices deliver pacing impulses to the heart muscle to resynchronize the contractions of the ventricles and thus increase cardiac pump efficiency.

As heart failure patients are up to 9 times more likely to suffer SCD than the general population(3), combining CRT with an implantable defibrillator (CRT-D) can be life-saving for these patients.

The first patients to be enrolled in the study were implanted with Sorin Group's Ovatio(TM) CRT, the world's smallest CRT-D. The device includes the unique Brady Tachy Overlap (BTO(TM)) function which allows the setting of low-rate detection zones for slow VTs, whilst still allowing pacing and delivery of resynchronization therapy during patient exercise.

The implants were performed at the St. Adolf-Stift Hospital in Reinbek, Germany by Dr. Herbert Nagele, Senior Assistant Medical Director, and at the Hospital Fernando Da Fonseca in Amadora, Portugal by Dr. Francisco Madeira, Assistant Cardiologist and Electrophysiologist, and by Dr. Pedro Cunha, Assistant Cardiologist, in the Pacing and Arrhythmia Unit headed by Dr. Carlos Morais.

Dr. Francisco Madeira commented: "this important study will give physicians better insight into the management of slow VTs for heart failure patients. It will be of particular interest because, until today, technology limitations restricted our ability to monitor and treat slow VTs in HF patients without compromising the delivery of cardiac resynchronization therapy ".

Andre-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit commented that "this study represents a continuation of Sorin Group's efforts to bringing innovative technology to each and every patient. Our objective is to demonstrate the ability of Sorin's unique BTO function to monitor the effects of slow VT for heart failure patients".

The BITAC study will enroll over 400 patients across Europe. Enrollment is anticipated to be completed by end 2007.

Sorin Group:

Sorin Group CRM Business Unit designs and manufactures implantable pacemakers and ICDs, leads and Holter equipment and markets them worldwide.

Sorin Group (Reuters code: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. Sorin Group includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin Group has more than 4,700 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

For additional information, please visit our website: www.sorin.com

REFERENCES

(1). Sadoul N., Mletzko R., Anselme F. et al. Internal sub analysis (375 patients) of the IDEF08 Slow VT study. Incidence and Clinical Relevance of Slow Ventricular Tachycardia in Implantable Cardioverter-Defibrillator Recipients: An International Multicenter Prospective Study. Circulation Aug16,2005, 946-953

(2). Cleland JG, Swedberg K, Follath F et al.The EuroHeart Failure Survey Programme- A Survey of the Quality of Care Among Patients with Heart Failure in Europe. Part 1: Patient Characteristics and Diagnosis. Eur Heart J 2003;24:442-463

(3). American Heart Association.Heart Disease and Stroke Statistics. 2005 Update. Dallas, Texas: American Heart Association

Sorin Group Director, Global Communications Martine Konorski, +33-1-46013605 martine.konorski@sorin.com or Director, Investor Relations Marilena Giavara, +44-20-70038730 marilena.giavara@sorin.com or Director, Communications & Industry Affairs Francesca Caprari, +39-02-6332322 francesca.caprari@sorin.com