Bi-Ventricular Pacemaker by Medtronics

and now....
FDA approval Thurday, May 2, 2002...

Bi-Ventricular Pacemaker PLUS Defibrillator from Guidant

FDA Approves Guidant's System for the Treatment of Heart Failure
Only Approved Technology to Treat Both Sudden Cardiac Death and Heart Failure

Indianapolis, Ind. and St. Paul, Minn. – May 2, 2002 – Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced that the U.S. Food and Drug Administration (FDA) has approved the CONTAK CD®/EASYTRAK® system for the treatment of heart failure. It is the first system approved that combines an implantable defibrillator with cardiac resynchronization therapy (CRT-D).
"Today's FDA approval reaffirms Guidant's leadership in device-based therapy for the treatment of heart failure.

We will immediately launch this pioneering therapy for the thousands of people in the United States who will benefit from both cardiac resynchronization therapy and the protection from sudden cardiac death," said Ronald W. Dollens, president and CEO, Guidant Corporation. "The approval offers heart failure patients and physicians new hope as they battle this debilitating disease."The CONTAK CD CRT-D device addresses the two primary concerns of physicians who treat heart failure patients-improving their quality of life and protecting them from sudden cardiac death (SCD).

The CRT function of the device helps the chambers of the heart beat in a coordinated manner, improving a heart failure patient's functional capabilities. The implantable defibrillator function corrects potentially life-threatening rapid heart rhythms, preventing sudden cardiac death. Half of all heart failure deaths are a result of end-stage, progressive pump failure, and the other half are due to sudden cardiac death."The approval of our CONTAK CD/EASYTRAK system greatly accelerates our ability to treat heart failure patients who are at risk for sudden cardiac death," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "Guidant has an outstanding, well-trained field force, a dedicated physician training program and a high-quality device-based therapy.

This industry leading combination immediately positions us exceptionally well to help those who suffer from heart failure."Heart failure currently affects nearly five million Americans and is increasing each year in both prevalence and incidence. Heart failure is a progressive cardiac illness in which the heart cannot pump enough oxygenated blood to meet the body's needs. In many cases, this inefficient pumping occurs because the four chambers of the heart are not working as a team. The timing, or synchrony, between the chambers is often poor. Consequently, the chambers do not fill and empty normally, so the heart's pumping efficiency is compromised.The new device is also distinguished by an innovative lead – called the EASYTRAK lead. The EASYTRAK lead, in conjunction with leads implanted in the right side of the heart, allows the CONTAK CD pulse generator to sense and stimulate both the left and right sides of the heart. The EASYTRAK lead design is the first to allow the physician to position the electrode in a vein on the left side of the heart using a convenient over-the-wire technique similar to the system used in angioplasty procedures. The EASYTRAK lead system demonstrated in clinical trials a low incidence of dislodgement or migration, allowing for better therapy and more precise sensing and stimulation of the left ventricle.

This device approval follows an unrelated landmark clinical trial – named MADIT II – sponsored by Guidant that was published in March in The New England Journal of Medicine. The MADIT II trial demonstrated that patients with a prior heart attack and compromised heart function who received an implantable defibrillator experienced a 31 percent reduction in mortality, compared to patients with optimal drug therapy alone.

InSYNC Pacemaker by Medtronics

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Medtronic's InSYNC Device
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More Info from Medtronic on InSYNC
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INDEX of Links to Other Sources

Heart Center Online
Explanation in excellent detail of the biventricular pacemaker (or InSYNC device).

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News Release:
Medtronic's InSync Cardiac Resynchronization Therapy Device Approved By FDA
CRT Ushers In a New Era of Device-based Solutions For the Treatment of Heart Failure

MINNEAPOLIS-August 28, 2001 - Medtronic, Inc., (NYSE:MDT)
... announced today that the U.S. Food and Drug Administration has approved its InSync® cardiac resynchronization therapy, the first major therapeutic breakthrough for heart failure since the development of specialized heart failure drugs. The treatment signals a new era in device-based solutions for this condition and brings hope to thousands of long-suffering patients who have moderate to severe heart failure.

Nearly 5 million Americans are afflicted with heart failure, which can be severely debilitating, often robbing patients of their ability to live independent, normal lives. Of these 5 million, it is estimated that more than 650,000 heart failure patients are candidates for the Medtronic InSync device because their heart failure is caused or exacerbated by ventricular dysynchrony, which occurs when there is a time delay between the beating of the heart's two lower chambers, or ventricles.

InSync cardiac resynchronization therapy is the first implantable therapy to be approved by the FDA for this large and growing heart failure patient population. "The InSync cardiac resynchronization system has succeeded in restoring patient quality of life and functional capacity beyond our expectations," said Dr. William Abraham, Professor of Medicine and Chief, Division of Cardiovascular Medicine at the University of Kentucky College of Medicine. Dr. Abraham was the lead clinical investigator for the MIRACLE study that tested the safety and effectiveness of the new therapy. "Heart failure is the most costly cardiovascular illness in America and one that increases in incidence and prevalence each year," Dr. Abraham said. Total heart failure costs in the U.S. are estimated at $38 billion annually and growing rapidly. Global costs range as high as $80 billion. "Cardiac resynchronization therapy will benefit thousands of patients immediately. It reduces the number of days patients need to be hospitalized and helps reduce the enormous financial burden on the health care system," added Dr. Abraham.

The Medtronic InSync cardiac resynchronization system includes a small pulse generator (about the size of two stacked silver dollars) that is implanted beneath the skin in the shoulder region. The FDA approval also covers two new Attain™ leads (insulated wires) that, along with other leads, deliver synchronized electrical stimulation to three chambers of the heart, enabling them to pump blood more efficiently throughout the body. The result is a dramatic improvement in exercise capacity, quality of life and functional status, allowing those who previously had limited ability to perform common tasks to resume a more normal daily routine.

The InSync system has been the answer to Janie Binning's prayers. Janie first met her husband Bob in church. She remembers thinking, "I was praying for a husband. Then, after I really learned how serious Bob's heart condition was, I was praying for a miracle." Bob wryly refers to his life before the InSync implant as "Death of A Salesman" because the debilitating illness forced the industrial steel sales representative from Ft. Myers, Fla, to retire early. As a New York Heart Association (NYHA) Class IV heart failure patient, Binning often slept 20 hours a day and had been hospitalized twice for his condition. Since the Medtronic InSync implant in 1998, Binning, now 60, has improved from a Class IV patient to Class II, and his life has changed significantly. (Class IV is considered severe and Class III moderate, while Class II is mild and Class I is asymptomatic).

He now works as an airport shuttle driver and recently, he installed hardwood floors in his home. Less than a year after his implant, he accompanied Janie on a church-sponsored mission trip to Nicaragua. "Before the InSync implant, I lived in fear of losing my life and of being helpless and bedridden," said Binning, who was the first patient in Florida to receive the device and the third in the U.S. "InSync gave us back our life as a couple by helping me be able to do more while experiencing less severe symptoms."

In a double blind, randomized, controlled clinical study conducted at 44 U. S. and Canadian centers over the past three years, patients using the InSync system:


Reduced their NYHA status by at least one classification in 68% of the CRT patient group, compared to 34% in the control group;

Increased their Quality of Life assessment by 13 points (as measured by the Minnesota Living with Heart Failure Questionnaire);

Increased their six-minute hall walk distance by more than 50 meters;

Experienced an 81 percent reduction in total days hospitalized for heart failure, and
Reported an overall improvement in their heart failure status as determined by a composite clinical response score that considered mortality, hospitalization for heart failure and worsening NYHA class.

"Throughout the clinical trial, we saw patients make tremendous improvement in their ability to function, improvement that exceeded that obtained by using standard heart failure-related medical therapy alone," said Dr. Abraham. "We are convinced that the InSync system is a valuable therapeutic option for certain heart failure patients, one that will make it possible for many who had lost hope of ever resuming normal activities to do so again." "We are extremely gratified by the prompt approval of the Food and Drug Administration for our InSync cardiac resynchronization system," noted Steve Mahle, president, Medtronic Cardiac Rhythm Management. "The FDA's keen understanding of the importance of this new therapy resulted in a rigorous, but expedient review in just six months.
Approval of this first-generation InSync system opens the door for additional device-based options that will continue to advance the treatment of heart failure and the quality of life for thousands of these patients."

The Medtronic InSync cardiac resynchronization system is also commercially approved outside the U.S. Medtronic filed a pre-market approval application with the FDA in May 2001 for InSync® ICD, which provides defibrillation protection for heart failure patients at risk for sudden cardiac arrest.

Both InSync ICD and InSync® III, a third-generation device, are available outside the U.S. InSync III remains under clinical evaluation in the U.S., as does a promising new diagnostic heart failure device called Chronicle®.

Heart failure patients, family members or others who would like more information about the InSync cardiac resynchronization system should call 1-800-893-3322.

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More On InSYNC from Medtronics 

Medtronic's new InSyncŪ System is the first implantable cardiac resynchronization system available in the United States. Cardiac resynchronization helps the heart pump blood more efficiently by causing the heart's lower chambers to beat at the same time.

Only your doctor can help you determine if cardiac resynchronization therapy is appropriate for you. Your physician may use the following criteria to determine if you are a potential candidate for cardiac resynchronization therapy.

You have ventricular dysynchrony -- that is, the two lower chambers of your heart (known as the left and right ventricles) are not beating together

You remain symptomatic despite stable, optimal medical therapy

Your heart failure has been classified by your doctor as Class III or IV (moderate to severe), using the heart failure classification system developed by the New York Heart Association

Your heart is not able to pump blood effectively (also called low ejection fraction)

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Last Modified on August 2, 2003