FDA Approves COMPANION Indication for Guidant CRT-D Systems
COMPANION indication extends CRT-D therapy benefits to more heart failure patients
As of September 15, 2004, the US Food and Drug Administration has expanded the existing indication exclusively for all Guidant cardiac resynchronization therapy defibrillator (CRT-D) systems, including CONTAK® RENEWAL™, CONTAK RENEWAL 3, and CONTAK RENEWAL 3 HE.
This expanded indication extends the benefits of Guidant's CRT-D therapy to heart failure patients, both ischemics and non-ischemics, who otherwise do not have an implantable cardioverter defibrillator (ICD) indication.
CRT patients are no longer required to have an ICD indication to receive a Guidant CRT-D.
This expanded indication stems from Guidant's landmark Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Trial.1
So what?
More patients can benefit…
Previously, CRT-D therapy was reserved for heart failure patients whose risk for sudden cardiac death was demonstrated by spontaneous or induced arrhythmias, or a previous myocardial infarction.
New Guidant indication allows physicians to offer life-saving care for the entire group of heart failure patients who are candidates for CRT.
And live better…
When compared to optimal pharmacologic therapy (OPT) alone, Guidant's CRT-Ds with OPT:
Significantly reduced the risk of all-cause mortality or time to first hospitalization
Improved quality of life
Reduced heart failure symptoms
And live longer…
Guidant's CRT-Ds with OPT significantly reduced the risk of all-cause mortality by 36% vs. OPT alone.
Did You Know?
The COMPANION Trial is the:
Largest CRT trial ever conducted
Only CRT trial to investigate mortality and hospitalization
Guidant is the only company to have FDA-approved specific labeling for CRT-D systems for this patient population.
Learn More
Speak with a Guidant representative at 1-800-CARDIAC (1-800-227-3422).
- Bristow MR, Saxon LA, Boehmer J, et al, for the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140-2150.
CRT-D Instructions for Use Summary
