Medtronic Seeks to Expand Indication for Heart Failure Device Therapy


May 26, 2009

May 26, 2009 – Medtronic intends to seek FDA approval for the use of cardiac resynchronization therapy (CRT) in certain mildly symptomatic heart failure patients.

While CRT is a proven life-saving therapy for some patients with advanced stages of heart failure (New York Heart Association Class III, IV), it is not currently approved for use in earlier stages, or mildly symptomatic patients.

“Results from large-scale studies like REVERSE suggest benefits with CRT for patients with mild heart failure,” said David Steinhaus, M.D., medical director of the cardiac rhythm disease management business at Medtronic. “For some heart failure patients, CRT appears to slow the progression of the disease, and delay time to first heart failure hospitalization or death – which can have a great impact to the healthcare system.”

In REVERSE, CRT used in combination with optimal medical therapy, including beta blockers and ACE inhibitors or aldosterone-receptor blockers, led to a statistically significant improvement in heart failure clinical composite score at 24 months, a standard measurement that includes several clinical measures of heart failure status.

“We look forward to continued discussions with the FDA on the role CRT can potentially play in heart failure treatment regimens for early stage heart failure patients,” Dr. Steinhaus said. “At Medtronic, our goal is to provide innovative solutions to the most challenging healthcare problems, and we are hopeful that earlier intervention with CRT will help both physicians and patients to better address this serious and often debilitating condition.”

Medtronic’s decision precedes anticipated results from the fully enrolled Canadian RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) study, which is evaluating the impact of CRT on all-cause mortality and heart failure hospitalization in NYHA Class II patients, as well as other industry trials that continue to assess CRT for mildly symptomatic heart failure patients.

REVERSE: initiated in 2004, this is the first large-scale, global, randomized, double-blind study to suggest the benefits of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms.

CARE-HF (Cardiac Resynchronization in Heart Failure): initiated in 2001, evaluated NYHA Class III, IV patients for 18 months and demonstrated CRT improves symptoms and reduces complications and risk of death.

MIRACLE/MIRACLE ICD (Multicenter InSync/ICD Randomized Clinical Evaluation) studies: initiated in 1998 and 1999, respectively, evaluated NYHA Class III, IV patients for six months and demonstrated significant improvements in quality of life and cardiac function.

Medtronic heart failure research studies currently underway include:

• BLOCK HF (Biventricular Versus Right Ventricular Pacing in Heart Failure Patients With Atrioventricular Block) trial: initiated in 2003, is determining the value of CRT in patients with AV block and at risk of developing worsening heart failure; trial sites in the U.S. and Canada.

• IMPROVE HF (Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting): designed to quantify and improve quality of care for heart failure patients by promoting the use of evidence-based, guideline-recommended therapies.

• OptiVol Care Pathway: assessing whether more frequent (monthly vs. quarterly) review of OptiVol Fluid Status Monitoring patient data results in earlier clinical intervention.

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