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K Number
K112372Device Name
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
Manufacturer
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
Date Cleared
2011-09-15
(29 days)
Product Code
DSP
Regulation Number
870.3535Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CARDIOSAVE™ Intra Aortic Balloon Pump is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation. The intra-aortic balloon is placed in the descending aorta, just distal to the left subclavian artery. Once the balloon is positioned, the pump is adjusted to trigger in synchrony with the ECG or arterial pressure waveform to ensure that inflation and deflation occur at the appropriate points during the cardiac cycle.
Device Description
The CARDIOSAVE™ Intra-Aortic Balloon Pump (1ABP) is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of an intra-aortic balloon (IAB) in the patient's descending aorta. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB inflation is initiated at the onset of diastole at the dicrotic notch and remains inflated through diastole. The IAB is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation.
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K Number
K112327Device Name
SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES
Manufacturer
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
Date Cleared
2011-09-09
(28 days)
Product Code
DSP
Regulation Number
870.3535Why did this record match?
Applicant Name (Manufacturer) :
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAQUET's SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter and Accessories have the following indications for use:
- Refractory Unstable Angina. .
- Impending Infarction. .
- . Acute Myocardial Infarction.
- . Refractory Ventricular Failure.
- Complications of Acute MI (ie. Acute MR or VSD or papillary muscle rupture)
- . Cardiogenic Shock.
- Support for diagnostic, percutaneous revascularization and interventional procedures.
- . Ischemia related intractable ventricular arrhythmias.
- . Septic Shock.
- . Intraoperative pulsatile flow generation.
- Weaning from cardiopulmonary bypass. .
- . Cardiac support for non-cardiac surgery.
- Prophylactic support in preparation for cardiac surgery.
- Post-surgical myocardial dysfunction/low cardiac output syndrome.
- . Myocardial Contusion.
- Mechanical bridge to other assist devices.
- Cardiac support following correction of anatomical defects
Device Description
The SENSATION® PLUS 8 Fr. 50cc IAB Catheter (SENSATION Plus) is an enhanced SENSATION 7Fr IAB Catheter which includes a catheter with accessories, an insertion kit and two STATLOCK® IAB Stabilization Devices. This device incorporates the fiber optic technology of the SENSATION 7Fr IAB Catheter with the increased membrane volume and French size of the Mega" 50cc 8Fr. IAB Catheter (K091449). The SENSATION® Plus Insertion kit contains the same components as currently used with the Mega 50cc 8Fr IAB Catheter with the sole exception that the SENSATION® Plus Insertion Kit does not contain two lengths (4-ft) of pressure tubing, due to the fact that pressure monitoring is accomplished via the fiber optic cable. In addition, the SENSATION® Plus Insertion Kit contains six extender tubing clips, similar to the predicate SENSATION® Insertion Kit.
The SENSATION™ PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter is a cardiac assist device. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end-diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle. These beneficial effects are caused by the inflation and deflation of the intra-aortic balloon (IAB) Catheter placed in the patient's descending aorta just below the subclavian artery. The balloon's inflation and deflation must be properly synchronized with the cardiac cycle. IAB Catheter inflation is initiated at the onset of the diastole at the dicrotic notch and remains inflated through diastole. The IAB Catheter is then deflated at, or just prior to, the onset of systole and the balloon remains deflated throughout systole. Hence, the therapy is also referred to as counterpulsation. This is the same intended use as other IAB Catheters.
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