Showing posts with label PRODUCT APPROVAL. Show all posts
Showing posts with label PRODUCT APPROVAL. Show all posts

Sunday, May 11, 2014

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).

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