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Muralidhar R

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Aug 26, 2008, 1:16:23 PM8/26/08

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BIOTRONIK:
EchoCRT, the Largest Trial of Its Kind, Enrolls First Patients Today

The EchoCRT Study Will Investigate the Life-Saving Benefits of Cardiac Resynchronization Therapy in Patients with Heart Failure Who Currently Do Not Receive Device Therapy

-- BIOTRONIK announced today the enrollment of the first patient into the EchoCRT (Echocardiography guided Cardiac Resynchronization Therapy) study. Drs William T. Abraham and Ralph Augostini at The Ohio State University Medical Center in Columbus, Ohio, USA, enrolled and implanted the Lumax HF-T CRT-D device in the first patients in EchoCRT. This technologically advanced cardiac device has many industry-leading features to save and enhance patients' lives and equipped with BIOTRONIK Home Monitoring(R) enables wireless, automatic daily data transmission of patients' cardiovascular and device status.

"The objective of EchoCRT is to demonstrate that optimal medical therapy plus CRT reduces all-cause mortality or first hospitalization for worsening heart failure in the study population compared to optimal medical therapy alone" said Dr Johannes Holzmeister, University of ZA 1/4rich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT. He added, "EchoCRT will provide valuable scientific evidence for this large group of heart failure patients who currently lack treatment options beyond pharmacological therapy."

"Cardiac resynchronization is a proven life-saving device-based treatment for certain heart failure patients with ventricular dyssynchrony, that is, discoordinated pumping action of the heart," Dr Abraham, Director of the Division of Cardiovascular Medicine at The Ohio State University Medical Center and US Principal Investigator of the study, explained. "Previous randomized controlled trials with CRT have been limited to patients with a so-called 'wide QRS,' an electrocardiogram (ECG) anomaly that shows longer-than-normal ventricular activity (QRS width a% 120 - 130 ms), who represent only 30% of all subjects with chronic heart failure. EchoCRT is designed to demonstrate whether patients with ventricular dyssynchrony but 'narrow QRS' or normal ventricular electrical activity on the ECG, may derive the same life-saving benefits from CRT device therapy as other heart failure patients."

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 (<130 ms) and echocardiographic evidence of left ventricular dyssynchrony. All patients will be implanted with the BIOTRONIK Lumax HF-T CRT-D device with BIOTRONIK Home Monitoring(R). 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.

In recognition of its substantial clinical benefits, CRT has been recommended in both the European Society of Cardiology (ESC) Guidelines and in the American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the diagnosis and treatment of chronic heart failure. However, these guidelines have limited the application of CRT to patients with a QRS width of a% 120 ms.1, 2 EchoCRT will assess whether some of the remaining 70% of heart failure patients with 'narrow QRS' could benefit from CRT therapy.

"The clinical community has long been intrigued as to whether 'narrow-QRS' heart failure patients with ventricular dyssynchrony would benefit from CRT," stated Kevin Mitchell, BIOTRONIK Vice President Clinical Studies. "The EchoCRT study has been designed under guidance from an executive steering committee of 11 internationally-renowned academic specialists in electrophysiology, heart failure and echocardiography who carefully considered earlier studies in developing the EchoCRT design. BIOTRONIK is proud to support this trial, which is part of our enduring commitment to landmark clinical research, to provide physicians with scientifically-sound evidence on which to base their clinical decisions. BIOTRONIK is also committed to improving patient outcomes and to achieve this, the company has significantly expanded its clinical trial program and has embarked on four large, international, landmark trials, including EchoCRT."

"Chronic heart failure is associated with a poor prognosis with considerably shortened survival and repeated hospitalizations. The vast majority of patients with heart failure present with a narrow QRS and do not currently receive CRT. The EchoCRT trial will test the hypothesis whether CRT improves outcomes in this large subset of heart failure patients," commented Dr Frank Ruschitzka, University of ZA 1/4rich, Executive Committee Co-Chairman and International Co-Principal Investigator of EchoCRT.
EchoCRT is an investigator initiated large-scale, prospective, randomized, controlled clinical trial and will be led by the University of ZA 1/4rich. GE echocardiography equipment will be utilized throughout the EchoCRT study and GE, as a clinical cooperation partner to BIOTRONIK in this study, will provide training and technical support in order to reduce data variability and ensure optimal reliability of outcomes. BIOTRONIK is the sole sponsor of the EchoCRT study being conducted under an investigational device exemption (IDE) granted by the FDA.

Reference
1. Swedberg K et al. Guidelines for the diagnosis and treatment of chronic heart failure. Eur Heart J. 2005; 26:1115-1140.

2. Hunt SA et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult--Summary Article. J Am Coll Cardiol 2005; 46: 1116-1143.

About BIOTRONIK GmbH & Co. KG
As one of the worlds 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.

Thanks & regards,

Muralidhar Rejeti.
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Muralidhar R

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Aug 28, 2008, 12:20:02 AM8/28/08

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FDA Clears Stereotaxis Magnetic Radio Frequency Guidewire for Peripheral Chronic Total Occlusions

-- Stereotaxis, Inc. (STXS), announced today that it has received regulatory clearance from the U.S. Food and Drug Administration for its magnetically tipped, PowerAssert(TM) radiofrequency (RF) guidewire to cross chronic total occlusions in the peripheral vasculature.

Occluded or blocked arteries occur in patients with advanced peripheral arterial disease (PAD), and if left untreated can result in ulcerations and gangrene as well as significantly increased risk of limb loss and death. Eight to twelve million people have PAD, according to the American Heart Association. Stereotaxis' magnetically steerable RF guidewire is designed to ablate through chronic total occlusions (CTOs) in peripheral arteries. Its Niobe Magnetic Navigation System directs the guidewire's distal tip very precisely, allowing for accurate and efficient navigation through difficult to treat regions of the peripheral vasculature and CTOs.

"The safety and accuracy of the Stereotaxis system has been well documented in electrophysiology procedures, as have its ergonomic advantages and reduction of fluoro exposure," said John Young, MD, Director, Cardiovascular Innovation Program, The Ohio State University Medical Center, Columbus, Ohio. "With a growing diabetic population and increased prevalence of PAD, I am eager to use the magnetic RF guidewire. This will be the first CTO crossing device that can enable true intra-lesion steering, and I expect it to substantially improve the range of options for CTO treatment."

"Traditional, manual guidewires used for CTO crossing have little or no steering ability and therefore can only be used with great difficulty in tortuous vasculature, requiring a high level of operator skill and carrying a risk of vessel perforation," said Bevil J. Hogg, CEO of Stereotaxis. "Just as the safety, accuracy and efficacy of our Niobe Magnetic Navigation System have contributed significantly to the treatment of patients with cardiac arrhythmias in the field of electrophysiology, we believe that our PowerAssert RF guidewire will improve the prospects for treating patients with peripheral arterial disease. PowerAssert opens a significant new market opportunity for Stereotaxis, underscoring the Niobe system's capabilities as a platform for a broad and growing array of interventional procedures."
Stereotaxis is planning a limited clinical introduction of the guidewire to begin later this year, with a broader commercial launch to follow.

About Stereotaxis

Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital's interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Stereotaxis System is designed to enable physicians to complete more complex interventional procedures by providing image guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation, shorter procedure time and reduced x-ray exposure. The core components of the Stereotaxis system have received regulatory clearance in the U.S., Europe, Canada, China and Australia.