BIOTRONIK Canada Inc.

BIOTRONIK Canada Inc.

February 12, 2010 15:29 ET

BIOTRONIK: EchoCRT, the Largest International Trial to Investigate the Benefits of CRT for HF Patients, Enrols First Canadian Patient

The EchoCRT study will investigate the life-saving and life-improving benefits of cardiac resynchronization therapy in patients with heart failure using Lumax HF-T CRT-D

BERLIN, GERMANY and TORONTO, ONTARIO--(Marketwire - Feb. 12, 2010) - BIOTRONIK announced the enrollment of the first patient into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) study in Canada. The EchoCRT team in Edmonton, Alberta, which includes Dr. Sajad Gulamhusein, Dr. Randall Williams, and Dr. Kenneth O'Reilly as primary investigators along with the joint efforts of the co-investigators and clinical support staff from the Grey Nun's, Royal Alexandra, and University of Alberta Hospitals, enrolled the first EchoCRT patient in Canada. The patient received a Lumax 540 HF-T CRT-D, a technologically advanced cardiac device with many industry-leading features to save and enhance patients' lives. The Lumax 540 HF-T CRT-D device is equipped with BIOTRONIK's industry leading Home Monitoring® system which enables wireless, automatic daily data transmission of patients' cardiovascular and device status.

As the largest, prospective, randomized, double-blind, international, multicenter clinical trial of its kind, the landmark EchoCRT study will randomize more than 1 250 patients with heart failure, already receiving current standard pharmacological therapy, with a 'narrow QRS' width (less than 130 ms) and echocardiographic evidence of left ventricular dyssynchrony. The first device within the EchoCRT study was implanted in 2008 in Ohio, USA. All patients are implanted with the BIOTRONIK Lumax HF-T CRT-D device with BIOTRONIK Home Monitoring®. The Home Monitoring data will be used in a pre-specified analysis to evaluate the frequency and duration of irregular heart rhythms. Patients will be followed for a mean duration of 24 months. The trial is being conducted at approximately 125 investigational centers worldwide, including sites in Australia, Canada, Israel, Europe and the US.

The implementation of the substantial EchoCRT study in Canada is just one symbol of BIOTRONIK's growing strength and global network in the cardiovascular market. As the pioneer in wireless remote monitoring technologies for patients with implantable cardiac pacemakers and defibrillators, BIOTRONIK is known for having its finger on the pulse of the medical community. The creative, experienced, and passionate team at BIOTRONIK is a reliable partner for physicians in Canada to find best solutions for the challenges they face every day. BIOTRONIK's quality standards are among the highest in the market, allowing BIOTRONIK to focus on their main goal, to help restore and secure patients' quality of life in a lasting way. The company has significantly expanded its clinical trial program and has started four large, international, landmark trials, including EchoCRT.

About BIOTRONIK

As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

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