FDA APPROVES MEDTRONIC COREVALVE SYSTEM

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Medtronic CoreValve System - P130021/S002

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Medtronic CoreValve System
PMA Applicant: Medtronic CoreValve LLC
Address: Medtronic CoreValve LLC, 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: June 12, 2014
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf13/P130021S002a.pdf

What is it? The Medtronic CoreValve System (often referred to as the CoreValve) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of pig tissue attached to a flexible, self-expanding, nickel-titanium frame for support.

How does it work? The CoreValve is compressed and placed on the end of a tube-like device called a delivery catheter. It is then inserted through the femoral artery in the leg. If the femoral arteries are not suitable, the valve can also be inserted through other arteries or through the aorta. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then released from the catheter, it expands on its own, and anchors to the diseased valve. The CoreValve functions the same as a normal valve, helping the blood flow properly by opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The CoreValve is used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of the patients die within two years if the diseased valve is not replaced.

The CoreValve should only be used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).

What will it accomplish? The CoreValve can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but the surgical procedure is highly risky, or too risky. In the U.S. clinical trial, the CoreValve was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. However, implanting the CoreValve also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, and the need for a permanent pacemaker. For some patients with coexisting conditions or diseases, the risks may be especially high. Patients should discuss with their doctors the benefits and risks of this device.

When should it not be used? The CoreValve should not be used in patients who:

have an infection in the heart or elsewhere.
have an artificial (mechanical) aortic valve.
cannot tolerate blood thinning medicines.
have sensitivity to Nitinol (Titanium or Nickel) or to fluid used during the procedure to   see internal structures (contrast media).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.

RESEARCHERS SAY NEW DEVICE WILL SAVE LIVES OF THOSE AFFLICTED WITH HEART FAILURE

FROM:  NATIONAL SCIENCE FOUNDATION 

A new tool for the early detection of heart failure

Researchers believe it will save lives and result in big savings to health care costs
Until recently, a reliable, low-cost, non-invasive method to measure changes that occur in the water content of the lungs did not exist. Yet, having such a device could be an important tool for the early detection of heart failure, which afflicts an estimated 5.1 million Americans and is a leading cause of hospitalization and death.

"There is a significant need," says Magdy Iskander, a professor of electrical engineering at the University of Hawaii at Manoa, and director of the Hawaii Center for Advanced Communications of the university's college of engineering, citing additional conditions that potentially could benefit from the new technology, including edema, emphysema, dehydration, blood infection, acute lung injury and the effects of critical burns.

"The impact could be tremendous, particularly for predicting heart failure," he says.

Heart failure costs the nation an estimated $32 billion annually, which includes the cost of health care services, medications to treat heart failure, and missed days of work, according to the federal Centers for Disease Control and Prevention. Furthermore, heart failure is a frequent reason patients are readmitted to hospitals within 30 days of their initial discharge.

"Annually more than one million patients are hospitalized due to heart failuree, which accounts for a total Medicare expenditure exceeding $17 billion," Iskander says.

The National Science Foundation (NSF)-funded scientist has invented a new type of stethoscope he believes will prompt significant and positive changes for patients suffering from heart failure and other related conditions. It attaches to the body surface much like an EKG sensor--there is no need to implant it--and uses a novel radio frequency (RF) sensor to detect small changes in lung water, and monitor vital signs including heart and respiration rate, and stroke volume. The device uses low level RF signals, two-thirds lower than the average cell phone signal, he says.

Since the lungs normally do contain some water, the idea is to first use the device to obtain a baseline in order to identify future changes, "before there are problems," he says. In hospitals, the stethoscope could be an important component of so-called "bridge clinics" that monitor patients after discharge to prevent readmission.

Under the Affordable Care Act, Medicare can reduce hospital payments for excessive readmissions. "Thus hospitals are motivated because now they are penalized when patients come back with heart failure within 30 days," he says.

He also envisions its use in "telemedicine," where an internet hookup will connect to a patient wearing the device, and will be able to measure important vital signs remotely, and transmit data on a regular basis, without having to go to the doctor or hospital in person, unless it is necessary.

"The most important thing is that we believe it will help save lives," Iskander adds. "But it also will almost certainly result in big savings in health care costs."

The cardio-pulmonary stethoscope evolved from research Iskander conducted years ago for the Air Force, when he was studying the effects of electromagnetic radiation on humans and developing safety standards for microwave exposure.

"We were trying to evaluate safe levels, and the biological effects of working with microwaves, and we were exploring the use of microwaves in medical applications," he says.

In doing so, he discovered that microwave signals reflect changes in lung water, forming the basis for his invention.

"If the lungs have too much water, the magnitude of the microwave signal is reduced because water absorbs microwaves," he says. "The more water, the weaker the signal."

NSF supported Iskander with a $50,000 Innovation Corps (I-Corps) grant, awarded in 2013, which supports a set of activities and programs that prepare scientists and engineers to extend their focus beyond the laboratory into the commercial world.

The goal of the I-Corps program is to help researchers translate their discoveries into technologies with near-term benefits for the economy and society. It is a public-private partnership program that teaches grantees to identify valuable product opportunities that can emerge from academic research, and offers entrepreneurship training to student participants.

Iskander recently formed a company, MiWa Technologies, which ultimately will manufacture and market the stethoscope. He has applied for patents, and is seeking additional funding for continuing research and to conduct clinical trials. A recent National Institutes of Health scientific review panel called the clinical significance of his work "very high," adding that the tool could "significantly impact the assessment and management of subjects with HF (Heart Failure) and respiratory failure."

Years ago, when he designed his first cardio-pulmonary stethoscope, he estimates that the components would have cost about $150,000 to build one instrument. Today, thanks to wireless technology and digital processing, the same components that go into manufacturing cell phones, his costs are but a fraction of that amount. Moreover, "the stethoscope actually is more accurate," he says.

-- Marlene Cimons, National Science Foundation
Investigators
Magdy Iskander
Nuri Celik
Zhengqing Yun
Marcelo Kobayashi

FDA APPROVES USE OF CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P) AND DEFIBRILLATORS (CRT-D)

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

Medtronic CRT-P and CRT-D Devices - P010015/S205 and P010031/S381

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Products Name: This approval is for the following Cardiac Resynchronization Therapy Pacemakers (CRT-P) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) devices:Medtronic, Inc.
Address: 8200 Coral Sea Street
Mounds View, MN 55112
Approval Date: April 10, 2014
Approval Letters: http://www.accessdata.fda.gov/ cdrh_docs/pdf/P100015S205a.pdf and http://www.accessdata.fda.gov/cdrh_docs/
pdf/P010031S381a.pdf
Consulta® CRT-P Model C4TR01
Syncra® CRT-P Model C2TR01

Consulta CRT-D Model D224TRK and D204TRM
Maximo II CRT-D Model D284TRK and D264TRM
Concerto II CRT-D Model D274TRK
Protecta XT CRT-D Model D314TRG and D314TRM
Protecta CRT-D Model D334TRG and D334TRM
Viva XT CRT-D Model DTBA1D1 and DTBA1D4
Viva S CRT-D Model DTBB1D1 and Model DTBB1D4
Brava CRT-D Model DTBC1D1 and DTBC1D4

What is it?

A Cardiac Resynchronization Therapy disclaimer icon  (CRT) device is a special pacemaker designed to treat symptoms of heart failure by sending specially timed electrical impulses to improve the timing, or resynchronize pumping action of the heart's lower chambers (right and left ventricles). This improved timing can help control symptoms from heart failure.

There are two types of implantable CRT devices: one that is only a pacemaker (CRT-P) and the other that is a combination of a pacemaker and defibrillator (CRT-D). Defibrillators can shock the heart rhythm back to normal should dangerously fast rhythms occur.

Each CRT device consists of a pulse generator (containing a battery and electronic circuitry) connected to insulated wires called leads that deliver electrical impulses to stimulate the heart. The synchronizing leads include a right ventricular lead (RV) and a left ventricular (LV) lead.

A CRT-D combination pacemaker and defibrillator has added features and ability so it is able to detect and treat dangerously fast heart rhythms. Only some individuals with a damaged heart muscle are likely enough to develop dangerous heart rhythms to need a defibrillator. A physician can determine whether a CRT-P or CRT-D device is most appropriate.

How does it work? Both CRT-P and CRT-D devices resynchronize the heart action by providing electrical impulses to improve timing of the right and left sides of the heart using RV and LV leads. The leads also carry signals from the heart to the device. The timing of the impulses is programmed by the doctor to restore a more natural timing and pumping of the heart muscle which can improve heart failure. The RV leads of CRT-D devices have additional features to deliver high voltage energy to defibrillate the heart should life-threatening, dangerously fast rhythms occur in the ventricles (ventricular arrhythmia) disclaimer icon .

When is it used? CRT-P and CRT-D devices have been approved for many years for patients with poorly synchronized right and left ventricles to improve their heart failure symptoms. Based on the results of a new clinical study called BLOCK HF, FDA is now expanding who is eligible (or “indicated”) for CRT. The new, added patients must have EACH of the following:

MUST have slow or absent ventricular heart beating (heart block) with symptoms that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms PLUS at least mild heart muscle damage The actual specific indications appear below. After evaluating a patient’s degree of heart damage and heart failure symptoms, a doctor can determine whether they fit the new BLOCK HF indication and would benefit from CRT.
CRT-P Device Indications:

Previously Approved by FDA:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV) despite stable, optimal heart failure medical therapy
PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%) PLUS electrocardiogram (EKG) signs of poor synchronization of the ventricles

New BLOCK HF Indication:

slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III) PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
CRT-D Device Indications:

Previously Approved by FDA:

The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications:

Patients with moderate to severe heart failure symptoms (NYHA Functional Class III and IV)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 35%)

PLUS EKG signs of poor synchronization of the ventricles

OR

Patients with mild to moderate heart failure symptoms (NYHA Functional Class II)

PLUS EKG signs of very poor synchronization of the ventricles (Left bundle branch block (LBBB) with a ventricular stimulation time greater than or equal to130 ms)

PLUS severe heart damage (cardiac ejection fraction [LVEF] less than or equal to 30%)

New BLOCK HF CRT-D Indication:
The primary use of a CRT-D system is for automated treatment of life-threatening ventricular arrhythmias. They also provide CRT in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following heart failure classifications:  slow or absent ventricular heart beating (atrioventricular block [AV block] expected to require a high percentage of ventricular pacing that would traditionally require a conventional pacemaker PLUS mild to moderate heart failure symptoms (NYHA Functional Class I, II or III)

PLUS at least mild heart muscle damage (cardiac ejection fraction [LVEF] less than or equal to 50%)

NOTE: heart failure medications must be optimized after the device is implanted.
What will it accomplish? Based on the results of the BLOCK HF clinical study, when used in the new population as described above, patients may benefit by experiencing less frequent heart failure worsening or need for urgent treatment.
When should it not be used? The contraindications for the CRT-P and CRT-D devices are listed below.

CRT-P Devices:

implantation with another bradycardia device
implantation with an implantable cardioverter defibrillator
There are no known contraindications for the use of pacing as a therapy to control heart rate. The patient’s age and medical condition, however, may determine the particular pacing system, mode of operation, and implant procedure used by the doctor.

automatic adjustment of pacing rate may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter.
Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms.

Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance.

Anti-tachycardia pacing (ATP) therapy is contraindicated in patients with an accessory antegrade pathwayCRT-D Devices:

Patients experiencing tachyarrhythmia with transient or reversible causes including, but not limited to, the following: heart attack (acute myocardial infarction), drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia disclaimer icon , or sepsis.

Patients who have a unipolar pacemaker implanted.
Patients with continuous ventricular tachycardia (VT) or ventricular fibrillation (VF).

Patients whose primary disorder is chronic atrial tachyarrhythmia in the absence of VT or VF. (NOTE: This contraindication does not apply to the Maximo II devices).

U.S. ARMY'S CAMPAIGN AGAINST SUPPLEMENTS

FROM: U.S. DEPARTMENT OF DEFENSE
Army Deaths Spur Successful Campaign Against Supplements
By Donna Miles
American Forces Press Service

WASHINGTON, April 18, 2013 - A "David-and-Goliath" scenario – an Army installation commander standing up to a multi-billion-dollar industry over the deaths of three of his soldiers – has borne fruit in a national Food and Drug Administration warning and the drug maker's decision to stop production of a controversial dietary supplement.

Army Gen. Dana J.H. Pittard, commander of Fort Bliss, Texas, and the 1st Armored Division, lauded USPlabs's announcement that it would stop production of Jack3d.

The supplement contains dimethylamylamine, or DMAA, a stimulant popular among bodybuilders and dieters that the FDA last week linked to elevated blood pressure and heart attacks.

Pittard's crusade against the supplement began in 2011, when two Fort Bliss soldiers, Pfc. Michael Sparling and Sgt. Demekia Cola, died of heart failure during physical training. Their autopsies reviewed that DMAA use was a contributing factor in their deaths.

In July 2012, another Fort Bliss soldier, Pfc. David Artis, died of heart stroke during physical fitness training. His death also was linked to DMAA use.

Pittard, who instituted a campaign to reduce suicides and other preventable deaths on arrival at Fort Bliss, immediately demanded that products containing DMAA be removed from the shelves of a commercial vitamin store outlet on the post. It was an unpopular move, he told reporters today, raising the ire of the Fort Bliss community, questions from some Army leaders, and criticism from manufacturers of supplemental products.

"But regardless, we stood firm in the face of that criticism," Pittard said. "We felt it was the right thing to do for our soldiers."

The pushback, he said, actually strengthened the resolve at Fort Bliss to take the fight beyond the installation's gates. Partnering with the Consortium for Health and Military Performance and the Pentagon's Department of Military and Emergency Medicine, Pittard and his staff set their eye on eradicating DMAA products across not only the Army, but also the entire Defense Department.

This unified campaign spurred the Army to ban supplements containing DMAA from all installations in March 2012. Four months later, the Defense Department followed suit, banning them from all U.S. installations. In the next promising development, the FDA issued an advisory last week warning consumers not to buy dietary supplements containing DMAA.

But the biggest victory, Pittard said, was the decision by USPlabs, the manufacturer of Jack3d, to stop using DMAA in its products.

"Yesterday's action by USPlabs really in many ways vindicates those on Fort Bliss who fought so hard and fought the supplement and billion-dollar drug industry on this issue," he said.

Pittard expressed thanks to the Army and Air Force Exchange Service and Army and DOD leadership for supporting the effort. He acknowledged that it took courage to collectively stand up to powerful drug companies and others who resisted their efforts.

"And we believe this will save countless lives in the future," he said.