Healthcare Industry News:  cardiac resynchronization therapy 

Devices Cardiology

 News Release - September 10, 2006

Three of Medtronic's Heart Failure Clinical Studies to Be Highlighted at Heart Failure Society of America Annual Scientific Meeting

MINNEAPOLIS--(HSMN NewsFeed)--Sept. 10, 2006--Medtronic, Inc., (NYSE:MDT ) today announced its planned activities at the Heart Failure Society of America (HFSA) 10th Annual Scientific Meeting, Sept. 10 -13 in Seattle, Wash. Three of the company's premier heart failure (HF) research studies will be showcased as part of the HFSA's first-ever Clinical Trial Row, which will provide an opportunity for companies to provide information regarding ongoing clinical trials in heart failure.



Medtronic will feature data from its REDUCE HF, IMPROVE HF and SENSE-HF clinical trials, in addition to several other data presentations and symposia of note. This focus on HF closely follows the publication of the latest guidelines on ventricular arrhythmias and sudden cardiac death (SCD), published by the American College of Cardiology (ACC), American Heart Association (AHA), and European Society of Cardiology (ESC), as well as guidelines issued by HFSA for the care of HF patients. These guidelines are significant for both HF clinicians and patients, as HF patients are six to nine times more likely to suffer sudden cardiac arrest.

About the Highlighted Clinical Research

Since 1997, Medtronic has supported more than 20 randomized, controlled trials evaluating device therapy in more than 8,000 HF patients. This research has resulted in several medical "firsts," among them the first U.S. Food and Drug Administration-approved resynchronization device for the treatment of HF, based on results from the groundbreaking MIRACLE (Multicenter InSync Randomized Clinical Evaluation) trial; and the first study of the risk of sudden cardiac death in a HF patient population with the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) study.

Presented at HFSA's Clinical Trial Row:

  • REDUCE HF (Reducing Decompensation Events Utilizing IntraCardiac Pressures in Patients with Chronic HF) trial seeks to determine the safety, efficacy and functionality of the Medtronic Chronicle┬« ICD system when used in HF patients indicated for implantable cardioverter-defibrillator (ICD) therapy. The blinded study is a prospective, randomized, single-blind, multi-center clinical trial being conducted at up to 75 sites in the United States involving approximately 850 patients with mild to moderate HF (NYHA Class II and III).

  • The first large-scale comprehensive registry and prospective quality-improvement initiative, IMPROVE HF (Registry to IMPROVE the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting) is designed to: characterize the management of HF patients in the outpatient setting; assess the effects of practice-specific process-improvement interventions on patient care; provide insight into the issues that impede implementation of HF treatment guidelines; and identify methods that will improve the quality of HF care in the outpatient setting.

  • SENSE-HF (Sensitivity of the InSync Sentry OptiVol feature for the Prediction of Heart Failure) is a study designed to evaluate the sensitivity of Medtronic's exclusive OptiVol┬« Fluid Trends feature in predicting HF hospitalizations with signs and/or symptoms of pulmonary congestion.

These and other Medtronic-supported studies will be featured in the HFSA's Clinical Trial Row, Sunday, Sept. 10-Tuesday, Sept. 12. Information about subjects studied, trial design and follow-up schedules will be presented on these company-sponsored poster boards in Exhibit Hall 4AB at the Washington State Trade & Convention Center.

"We continually seek innovative solutions to improve the lives of heart failure patients through the application of device therapy," said Steve Mahle, president of the Cardiac Rhythm Disease Management business unit at Medtronic. "Clinical research that addresses the important issues facing clinicians in their everyday practice is critical to advancing the care of heart failure patients."

Symposia of Note

In addition to its focus on leading-edge clinical trials, Medtronic will support two satellite mini-symposia during the HFSA annual meeting. On Monday, Sept. 11, Dr. William H. Gaasch will lead a panel discussion titled, "Management Strategies for Patients With Diastolic Heart Failure." Faculty includes Drs. William C. Little, Philip B. Adamson, and Michael R. Zile. On Tuesday, Sept. 12, Dr. Gregg C. Fonarow will lead a panel discussion titled, "Improving Heart Failure Management: Evidence-Based Medications, Device Therapy and Monitoring." Faculty includes Drs. Clyde W. Yancy and William T. Abraham. Both sessions will be held from 12:30-1:30 p.m. These symposia are not part of the scientific program as planned by the HFSA Scientific Program Committee.

About the Guidelines

Recently released ACC/AHA/ESC guidelines recommend device therapy as standard of care for indicated patients who have had a ventricular arrhythmia or who are at risk for developing ventricular arrhythmias. The new guidelines confirm, consolidate and reinforce HF guidelines for the treatment of sudden cardiac arrest (SCA) with device therapy issued in 2005.

"We commend the ACC, AHA and ESC for their joint guidance on the management of patients who have experienced or are at risk of developing ventricular arrhythmias," said David Steinhaus, MD, vice president and medical director, Medtronic Cardiac Rhythm Disease Management. "Physicians in the U.S. and Europe now have a set of consistent, clinical guidelines that can help save the lives of millions of people worldwide."

Earlier in 2006, HFSA released updated guidelines for living with and treating HF. These guidelines complement the ACC/AHA Heart Failure Guidelines, which recommend device therapy as standard of care for HF patients already on optimal medical therapy who meet cardiac resynchronization therapy (CRT) and/or ICD indications.

"We firmly believe that clinical research, the various guidelines, and recommendations issued for heart failure patients further reinforce the effectiveness of device therapy," Steinhaus continued. "Medtronic is firmly committed to working with the appropriate parties to institutionalize these guidelines in an effort to prevent unnecessary deaths from SCA and improve the care of heart failure patients worldwide."

HF afflicts more than 22 million people worldwide, including 5 million Americans, and its incidence is rising with approximately 550,000 new cases diagnosed annually in the United States. With approximately 1 million hospitalizations each year for HF, the management of this condition is a tremendous cost burden to the U.S. healthcare system.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 28, 2006. Actual results may differ materially from anticipated results.


Source: Medtronic

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