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Terumo Europe N.V. Announces the Initiation of TROFI

Randomized study to assess the effect of thrombus aspiration on flow area in STEMI patients: an Optical Frequency Domain Imaging (OFDI) study.

24/11/2010 - Leuven, Belgium

Terumo Europe N.V., announced today the enrolment of first patients in TROFI a pioneering study to prove the benefits of thrombus aspiration in the treatment of patients with ST-Elevation Myocardial Infarction (STEMI) using latest optical imaging technology – Optical Frequency Domain Imaging.

TROFI is a randomized, prospective, multicenter study with the main objective to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device (Eliminate™) as compared to primary PCI without thrombectomy increases minimal flow area after stenting for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI) as assessed by OFDI. The study is scheduled to enroll 140 patients in five leading centres in Europe.

Patients will be randomly assigned to two arms: in the first arm patients will be treated by the newest generation thrombus removal device (Eliminate™) which showed high deliverability and aspirations capacity; in second arm patients will be treated by conventional percutaneous intervention without attempt to remove thrombus. All patients will be treated by Nobori® DES which showed excellent performance in NOBORI STEMI study that enrolled 249 STEMI patients and reported 4.4% of target lesion failure at 12 months.

Dr Leif Thuesen, a Principal Investigator of University Hospital Skejby, Aarhus, Denmark said: I am excited with the chance to enroll first patients in this highly interesting study using several innovative devices, particularly OFDI imaging system that offers us images never seen before, in the fraction of minute.

Professor Patrick Serruys of Erasmus Medical Centre Rotterdam, The Netherlands, the Principal Investigator and Chairman of Executive Operational Committee added: Enrolment of first patient in TROFI study is an excellent news and we are confident that this study will offer some answers that interventional cardiologists were seeking for quite some time. Minimal flow area as a new endpoint in clinical trials is expected to have predictive values on clinical outcome, while the visual images obtained by OFDI, that fascinated us in the first in man study, will help us understand what is going on inside the artery when we do procedures.

Shogo Ninomiya, President and CEO of Terumo Europe N.V. commented that this study continues to show Terumo's determination in providing the scientific community with clinical evidence relevant for daily practice. TROFI results will further confirm Terumo's leading position in management of patients with acute myocardial infarction, which has been a company focus in the last few years.

About OFDI

TERUMO-OFDI system is a light-based imaging technology that digitally processes interference signal of backscattered light from the vessel wall and reference light to construct a relevant (~ 20 µm resolution in tissue) intravascular cross-sectional high-resolution image. In the recently completed first in man study, OFDI showed superior detection ability of thrombus, tissue prolapse, dissection and incomplete stent apposition as compared to IVUS, with no adverse events related to the device.

About Nobori® DES system

Nobori® is the latest generation of DES with an innovative concept and proven results. Nobori® DES system employs biodegradable polymer and Biolimus A9™ coated only abluminally on the stainless steel platform.

About Eliminate™

Eliminate™ is a double lumen rapid exchange thrombus aspiration catheter with high aspiration capacity thanks to a large inner lumen and enhanced deliverability due to incorporated stylet.

OFDI Technology has been licensed from Massachusetts General Hospital, USA
Biolimus A9™ is proprietary of Biosensors International, Singapore

About Terumo

Terumo is a global health care company dedicated to research, development, manufacturing and marketing of medical products and equipment, including pharmaceuticals, nutritional food supplement, blood bags, disposable medical devices, cardiovascular systems, vascular grafts, peritoneal dialysis, blood glucose monitoring system, medical electronic, and digital thermometers. The company vision is to contribute to society through health care using its unique technology which makes medical treatment kinder and gentler. Terumo employs more than 13.700 people and its products are available in over 160 countries world-wide.

For more information

Olivier Archer