Heart Health News Archive

Qualified Health Claim Links Olive Oil to Lowered Risk of Heart Disease
Source: FDA Allows Qualified Health Claim to Decrease Risk of Coronary Heart Disease, FDA Press Release, November 1, 2004

The Food and Drug Administration today announced a qualified health claim linking monounsaturated fat from olive oil to a reduced risk of coronary heart disease (CHD). There is limited but not conclusive evidence that suggests that consumers may reduce their risk of CHD if they consume monounsaturated fat from olive oil and olive oil-containing foods in place of foods high in saturated fat, while at the same time not increasing the total number of calories consumed daily.

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FDA Approves Temporary Artificial Heart
Source: FDA Approves Temporary Artificial Heart, FDA Talk Paper, October 18, 2004

The Food and Drug Administration (FDA) has approved a partial artificial heart intended to keep people alive in the hospital while they are awaiting a heart transplant.

The product is a pulsating bi-ventricular device that is implanted into the chest to replace the patient's left and right ventricles (the bottom half of the heart). The implanted device is sewn to the patient's remaining atria (the top half of the heart). Hospitalized patients are connected by tubes from the heart through their chest wall to a large power-generating console, which operates and monitors the device.

The heart is manufactured by Syncardia Systems Inc., of Tucson, Ariz. It is intended as a "bridge to transplant" for people waiting for a heart transplant who do not respond to other treatments and are at risk of imminent death from non-reversible bi-ventricular failure, i.e. people with both left and right side heart failure, and who are eligible for a heart transplant.

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Consumer Information

Automatic External Defibrillator Now Available without Prescription
Source: FDA Clears Over-the-Counter Sale of Automatic External Defibrillator, FDA Talk Paper, September 16, 2004

The Food and Drug Administration (FDA) today granted marketing clearance for the first time for the over-the-counter sale of an automatic external defibrillator designed specifically for lay users. The device shocks the heart to restore rhythm in people who are experiencing cardiac arrest. The device, the HeartStart Home Defibrillator manufactured by Philips Medical Systems of Andover, Mass., is already available with a prescription for use at home. Today's clearance means it can now be purchased for home use without a prescription.

Automatic external defibrillators (AEDs) are used to treat people in cardiac arrest whose hearts are beating irregularly (fibrillating). Built-in computers analyze the rhythms and determine which rhythms require defibrillation shocks. Voice and visual prompts guide the user through the process.

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FDA Approves First Carotid Stent
Source: FDA Approves New Stent System to Help Prevent Stroke, FDA Press Release, August 31, 2004

The Food and Drug Administration (FDA) has approved a stent for opening blocked arteries in the neck. The new stent is intended to prevent stroke by treating blockages in the carotid artery, the main blood vessel leading to the brain.

The device--the first of its kind--was approved for use in patients who have had symptoms of a stroke or whose carotid artery is at least 80 percent blocked, and who are not good candidates for a surgical alternative.

The new system, manufactured by Guidant Corporation, of Santa Clara, Calif., is inserted during angioplasty, a procedure in which the stent is threaded up to the neck artery via a catheter inserted in the groin. Patients usually require only local anesthesia.

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Panel Votes to Allow Non-Prescription Defibrillator
Source: Circulatory System Devices Panel Meeting, July 28-29, 2004

An expert advisory panel to the U.S. Food and Drug Administration voted 8-0 to remove the prescription requirement for the Philips HeartStart Home Defibrillator cleared in November 2002. This device is intended to be used to treat sudden cardiac arrest. A person in sudden cardiac arrest:

• does not respond when shaken, and
• is not breathing normally.

The FDA is not bound by the decisions made by advisory panels, but it often follows them.

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Learn more about July 28-29, 2004 Circulatory System Devices Panel Meeting

FDA Approves Two New Implantable Cardioverter Defibrillators

Source: CDRH New Device Approval, St. Jude Medical® Epic™ HF and Atlas® + HF Dual Chamber Implantable Cardioverter Defibrillator Systems with Cardiac Resynchronization Therapy, June 30, 2004

FDA has approved two new implantable cardioverter defibrillators (ICDs) that also deliver cardiac resynchronization therapy (CRT) for patients with advanced heart failure. When the products function as ICDs, they sense dangerous abnormal heart rhythms and shock the heart back into its normal rhythm. The CRT portion of the devices coordinates the beating of the left and right ventricles so that they work together more effectively to pump blood throughout the body. The products are the Epic HF and Atlas + HF ICD Systems, manufactured by St. Jude Medical, Inc., of Sunnyvale, California.

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FDA Clears Robotic Heart Surgery Device
Source: FDA Clears Robotic-Like Device for Heart Surgery, FDA Talk Paper, July 7, 2004

The Food and Drug Administration (FDA) has cleared the marketing of a robotic-like system to assist in coronary artery by-pass surgery. The device enables a surgeon to perform heart surgery while seated at a console with a computer and video monitor. The surgeon uses handgrips and foot pedals on the console to control three robotic arms that perform the surgery. It gives surgeons additional manipulation ability during surgery, providing easier, more intricate motion and better control of tools.

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FDA Approves Iliac Artery Stent
Source: CDRH New Device Approval, IntraStent® DoubleStrut™ Stent, June 8, 2004

FDA has approved a new stent to treat patients with narrowing of an iliac artery caused by atherosclerosis, the collection of fatty substances such as cholesterol that forms “plaque” along the lining of the arteries. The product is the IntraStent DoubleStrut Stent, manufactured by ev3 Inc., of Plymouth, Minnesota.

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Panel Votes Down New Use for Heart Device
Source: Circulatory System Devices Panel Meeting, June 8, 2004

An expert advisory panel to the U.S. Food and Drug Administration voted 10-1 against expanding the use of the World Heart N100PC(q) Left Ventricular Assist System (LVAS). The Panel cited concern with the lack of data to support the safety and effectiveness for the proposed expansion of the intended use for the device. The FDA is not bound by the decisions made by advisory panels, but it often follows them.

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Learn more about June 8, 2004 Panel Meeting

Panel Recommends Stent for Approval with Conditions
Source: Circulatory System Devices Panel Meeting, April 21, 2004

An expert advisory panel to the U.S. Food and Drug Administration has voted to approve with conditions the Cordis Corporation's Cordis Precise Nitinol Stent System. The device is indicated for use in the treatment of carotid artery disease in high-risk patients. The panel's conditions included changes in labeling and follow-up studies. The FDA is not bound by the decisions made by advisory panels, but it often follows them.

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Learn more about April 21, 2004 Panel Meeting

Panel Recommends Approval of Artificial Heart
Source: Circulatory System Devices Panel Meeting, March 17-18, 2004

An expert advisory panel to the U.S. Food and Drug Administration has voted to approve an updated version of the artificial heart that was first used more than 20 years ago. The CardioWest Total Artificial Heart is being promoted by manufacturer SynCardia Systems Inc. as a way to help keep congestive heart failure patients alive long enough to receive a heart transplant. The FDA is not bound by the decisions made by advisory panels, but it often follows them.

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Qualified Health Claim to Appear on Walnut Labels
Source: FDA Moves Forward on Qualified Health Claims, FDA Press Release, March 31, 2004

The Food and Drug Administration today announced that a qualified health claim linking walnuts and a reduced risk of coronary heart disease will soon appear on product labels. This qualified health claim is part of the FDA’s initiative to provide Americans with better information to help them make healthier dietary choices.

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FDA Proposes Plan to Fight Obesity
Source: FDA Proposes Action Plan to Confront Nation's Obesity Problem, FDA Obesity Working Group Final Report, March 12, 2004

HHS Secretary Tommy G. Thompson today released a new U.S. Food and Drug Administration report outlining the agency's strategy for combating the epidemic of obesity that threatens the health of millions of Americans with a focus on the message, "calories count."

The report by FDA's Obesity Working Group includes recommendations to strengthen food labeling, to educate consumers about maintaining a healthy diet and weight and to encourage restaurants to provide calorie and nutrition information. It also recommends increasing enforcement to ensure food labels accurately portray serving size, revising and reissuing guidance on developing obesity drugs and strengthening coordinated scientific research to reduce obesity and to develop foods that are healthier and low and calories.

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FDA Approves Heart Assist Device for Children
Source: FDA Talk Paper, FDA Approves Heart Assist Device for Children, February 26, 2004

FDA today approved a Humanitarian Device Exemption (HDE) for a miniaturized heart pump for children aged 5 to 16 who are awaiting a heart transplant. The product, called a ventricular assist device, is designed to help the left ventricle of the heart pump blood. Use of the device may allow children with severe left ventricle failure to survive long enough to receive a heart transplant. The product is the DeBakey VAD Child, manufactured by MicroMed Technology, Inc., of Houston.

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Consumer Information

Poor Fitness in Young Adults Increases Cardiac Risk
Source: Poor Fitness in Young Adults Associated With Later Cardiovascular Problems, FDA Consumer Magazine January-February 2004

Poor fitness in young adults is associated with the development of cardiovascular disease risk factors later in life, a new study indicates. Researchers at Northwestern University's Feinberg School of Medicine investigated whether low fitness was associated with the development of risk factors for cardiovascular diseases (CVDs) and whether improving fitness was associated with risk reduction.

After adjustment for age, race, sex, smoking, and family history of diabetes, hypertension or premature myocardial infarction [heart attack], participants with low fitness (less than 20th percentile) were 3- to 6- fold more likely to develop diabetes, hypertension, and the metabolic syndrome than participants with high fitness (at or above 60th percentile).

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FDA Approves Single Drug for Cholesterol and Blood Pressure
Source: Single Drug for Cholesterol, Blood Pressure Approved, healthfinder.gov news, February 3, 2004.

FDA has approved the Pfizer drug Caduet for simultaneous treatment of both high cholesterol and high blood pressure. The single pill contains ingredients from both the cholesterol drug Lipitor (atorvastatin calcium) and the blood pressure medication Norvasc (amlodipine besylate).

The two conditions are leading factors for heart attack and stroke, and some 30 million people in the United States have both, Pfizer says. More than 3,700 people are enrolled in clinical trials, which showed that many participants reached goals for lowering both blood pressure and cholesterol, the company adds in a prepared release.

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FDA Approves New Pacemaker for Heart Failure
Source: PMA Final Decisions Rendered for January 2004

FDA approved a new pacemaker on January 26, 2004. This pacemaker, called the CONTAK RENEWAL TR pulse generator, is indicated for patients who have moderate to severe heart failure including left ventricular dysfunction. It includes tracking modes to help preserve AV synchrony and adaptive-rate pacing for patients who would benefit from adjusted pacing rates with physical activity. The pacemaker is manufactured by the Guidant Corporation, in St. Paul, Minnesota.