New Data Presented at ACC.09 Shows Benefit of Cardiac Resynchronization Therapy in Mildly Symptomatic Heart Failure Patients

ORLANDO, Fla. & MINNEAPOLIS--(BUSINESS WIRE)--Mar 31, 2009 - New research shows cardiac resynchronization therapy (CRT) may improve clinical outcomes in asymptomatic or mildly symptomatic heart failure patients, and clinical results revealed a 62 percent reduction in the risk of first heart failure hospitalization or death. The 24-month findings from the REVERSE (Resynchronization Reverse Remodeling in Systolic Left Ventricular Dysfunction) trial, sponsored by Medtronic, Inc. (NYSE: MDT), show the potential benefits of CRT in patients with mild heart failure.

Currently, CRT is not approved for use in mildly symptomatic or asymptomatic patients who were shown to benefit from CRT in this trial. Data was presented today as a late breaking clinical trial at the 58th Annual Scientific Session of the American College of Cardiology (ACC).

REVERSE Key Findings

The data show that CRT used in combination with optimal medical therapy, including beta blockers and ACE inhibitors or aldosterone–receptor blockers, demonstrated a statistically significant improvement in heart failure clinical composite response, a standard measurement that includes several clinical measures of heart failure status.

  • A 62 percent reduction in the risk of death or heart failure hospitalization between patients with CRT turned on and CRT turned off (p=0.003) was observed in the study.
  • Far fewer patients – 19 percent – of those treated with CRT had worsened at 24 months, compared with 34 percent who did not receive CRT (p=0.01).
  • The study also showed CRT leads to a reduction in heart size, as measured by cardiac ultrasound, improving its function and helping the heart pump more efficiently.

“The data demonstrate that even for patients who have mild or no heart failure symptoms, CRT may have a positive impact on clinical outcomes,” said Jean-Claude Daubert, M.D., FACC, Department of Cardiology, Centre Hospitalier Universitaire, Rennes, France. “Preventing the progression of heart failure with device therapy may also delay the time to first hospitalization or death, thus not only helping improve patients' lives, but ultimately reducing the economic burden of heart failure to the health system.”

With 610 patients studied, REVERSE is the first large-scale, global, randomized, double-blind trial to demonstrate the benefits of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. These latest results represent findings at 24 months for the European blinded cohort of 262 patients. As previously reported, the trial trended toward, but did not meet statistical significance for its primary endpoint (percent of patients worsened at 12 months using a heart failure clinical composite score), with more patients in the trial improved with CRT. This benefit was confirmed and was statistically significant with the 24 month results.

“The REVERSE data released today shows clear benefits for patients with mild heart failure,” said Marshall Stanton, M.D., vice president of clinical research for the Cardiac Rhythm Disease Management business at Medtronic. “With the REVERSE results and other Medtronic-supported large randomized heart failure trials, we're able to demonstrate that cardiac resynchronization therapy for this investigational patient population may improve outcomes and will play an important role in the treatment regimen for heart failure patients.”

REVERSE and the Medtronic-supported RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure) trial, which recently completed enrollment, are among several clinical trials underway to determine whether patients with mild or fewer symptoms (NYHA Class I and II) may benefit from cardiac resynchronization therapy.

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 25, 2008. Actual results may differ materially from anticipated results.

Editor's Notes:

Caution: The CRT devices used in the REVERSE trial are investigational for the patient population studied; their use is limited by federal (or United States) law to investigational use for this indication.

The embargo on the REVERSE data lifts at 9:15 a.m. EDT, Tuesday, March 31, 2009, per the ACC Embargo Policy: “Media are required to abide by the embargo policies governing ACC's annual meeting. The embargo policy states that coverage of abstracts being presented at the annual meeting is strictly prohibited until the start time of the presentation or the beginning of the media briefing containing the research, whichever comes first.”

Contact: Medtronic, Inc.
Public Relations
Kyra Schmitt, 763-526-2490
On-site at ACC 612-670-9011
or
Investor Relations
Jeff Warren, 763-505-2696

Posted: March 2009

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