The HeartMate II LVAD is capable of pumping the entire. You can wear it under a sweater or jacket – t- shirt doesn’ t stand out, you can easy match it with your clothing. Initiating Pump Operation. Many have passed the 5- year milestone on therapy, with some still on therapy after 10- plus years— living proof for over a decade that HeartMate II LVAD delivers predictable surgical and clinical performance for improved outcomes. The recall does not involve return of the device, but rather a change in the labeling on the Thoratec HeartMate II LVAS to provide instructions on how to verify if the bend relief is fully engaged with the sealed outflow graft at the time of implant.
A series of studies involving the use of the HeartMate II LVAD have proven useful in establishing the viability and risks of using LVADs for bridge- to- transplantation and destination therapy. Heart - Coronary Artery Bypass Graft ( CABG off- pump) PreOp® Patient Education HD - Duration: 6: 08. The primed LVAD pump was brought into the operating field. Most HeartMate II patients also experience an improved quality of life.
It is attached between the apex of the left ventricle and the ascending aorta. HeartWare Left Ventricular Assist System Instructions for Use: HeartWare Corporation,. • When venting is. 2% of the patient population) of patient. A general overview of teh HeartMate II Left Ventricular Assist System is.The driveline was screwed to the HeartMate II driveline tunneler. The Heartmate II is a left ventricular assist device ( LVAD) that is implanted alongside the patient' s native heart. It is designed for long- term use and is not targeted as a bridge to transplant.
HeartMate II™ LVAS Indications: The HeartMate II Left Ventricular Assist. The internal surfaces of the HeartMate II LVAD ( rotor,. Do not use the HeartMate II™ Left Ventricular Assist Device in pregnant.
Designed for people with LVAD HeartMate II or HeartMate III pump, by patients suffering from heart failure and VAD experts. Operating life of greater than 500 charge and discharge cycles. The HeartMate II left ventricular assist device ( LVAD) is an axial- flow rotary ventricular assist device composed of a blood pump, percutaneous lead, external power source, and system driver. Com/ medical- professionals/ resource- library/ ifus- manuals/ heartmate- ll- lvad. Join Abbott Cardiovascular at the HRS conference. LVADs vary in size, but the HeartMate II - the smallest of all the FDA- approved LVADs - measures approximately 3 inches in length and weighs approximately 10 ounces.
The HeartMate II Left Ventricular Assist System is indicated for use as a “ bridge to transplantation” for cardiac transplant candidates who are at risk of imminent death from non- reversible left ventricle failure. As of February 4,, Thoratec has received four ( 4) reports ( 0. 2% for the HeartMate II™ LVAD in the MOMENTUM 3 trial at 6 months. Heartmate 3 lvad makes a real difference in patient lives. TLC- II Plus Portable VAD Driver with Tablet and System Instructions for Use.Intermediate- to- chronic left ventricular assist device. Please refer to the HeartMate II LVAD Instructions for Use about indications, contraindications, adverse events, warnings, and. HeartMate II & III and HeartWare LVAD Training Class Fee: Free. Is a Full Service Provider of Heartmate II LVAD Accessories and Driveline Stabilization Supplies located in Gainesville,, Florida
Over 25, 000 heart failure patients have received the HeartMate II LVAD. How big are LVADs? The class is intended for Sharp RNs, physical therapists, occupational therapists, speech therapists and all RNs who are new to Heartmate LVAS and the HeartWare LVAS or would like a refresher. Brief Summary: Prior to using these devices, please review the Instructions For Use for a complete listing of indications,. • Contain lithium ion cells to power the HVAD® Pump.
Find information on booth hours, case presentation schedules, key clincial sessions and Abbott sponsored programs and events. View and Download Thoratec HEARTMATE II instructions for use manual online. The system consists of an internal pump that is connected to an external unit containing batteries and controls. LVAD clothing has a deep neckline, neutral color, no attention- grabbing prints. Jude Medical Inc. Com Patient Engagement - Patient Education 1, 706, 733 views. The HeartMate II device, which can cost as much as $ 330, 000 with implantation, has become the most widely used heart pump in the world, with nearly 29, 000 devices sold. The pilot trial for the HeartMate II LVAD began in November and consisted of 46 study patients at 15 centers.
Using the tunneler, the driveline. 1 The HeartMate II. If a battery provides only two hours of support duration, it should be replaced. HeartMate II is the only continuous- flow LVAD that has been approved for both Bridge- to- Transplantation and Destination Therapy. * Never operate the HeartMate II Left Ventricular Assist Device. Heartmate 3 lvad outcomes made possible by full maglev™ flow technology. What is the HeartMate II LVAD? HeartMate I1L VAS Operating Manual ( document # before attempting.
There is no significant difference between the HeartMate 3 and HeartMate II LVADs with regard to stroke or gastrointestinal bleeding in the MOMENTUM 3 study: 7. Measured via manual blood pressure cuff and auscultation ( the start of Korotkoff sounds is assumed to represent mean blood pressure) or by Doppler assessment is the primary parameter for monitoring blood pressure. The ongoing national shortage of available donor hearts, coupled with the design limitations ( and associated 1- year survival of 53% ) of older generations of pulsatile left ventricular assist device ( LVAD) pumps, has necessitated continuing evolution of these complex devices.
• Before using any HeartMate power accessories ( Power Module/ Power Base Unit, batteries, Universal Battery Charger), all users ( including clinicians, patients, and. Managing the Equipment. What is Heart Failure?
Com Patient Engagement - Patient Education 1, 706, 733 views. The HeartMate II device, which can cost as much as $ 330, 000 with implantation, has become the most widely used heart pump in the world, with nearly 29, 000 devices sold. The pilot trial for the HeartMate II LVAD began in November and consisted of 46 study patients at 15 centers.
A heart transplant remains the ultimate surgical therapy for advanced heart failure. HeartMate II LVAS Operating Manual ii. Over 25, 000 heart failure patients have received the HeartMate II™ LVAD. Image: HeartMate II LVAD courtesy of Abbott. 9% for the HeartMate 3 LVAD, respectively, vs 10. • Each battery provides 4 to 6 hours when fully charged.
HEARTMATE II Medical Equipment pdf manual download. Sends power and operating. IDE Clinical Trial. In most cases with a HeartMate II* LVAD, advanced heart failure patients can experience a dramatic improvement in their heart failure symptoms.
With oxygen- rich blood flowing throughout the body, most people say they feel better and have more energy. • The capacity of each battery in hours is based on: • Controller and pump operating. Approved for use in the EU, HeartMate PHP is an acute percutaneous heart pump with a low insertion profile that disrupts the traditional relationship between size and flow to deliver near– full physiological mean blood flow. The HeartMate 3 Left Ventricular Assist System ( LVAS) ( St.
HeartMate Universal Battery Charger Instructions for Use ( IFU) and the corresponding HeartMate II or HeartMate XVE LVAS IFU, Operating Manual, and / or Patient Handbook before use. Irrespective of the cause of cardiac arrest, early recognition and calling for help, including appropriate management of the deteriorating patient, early defibrillation, high- quality cardiopulmonary resuscitation ( CPR) with minimal interruption of chest compressions and treatment of reversible causes, are the most important interventions. Heartmate ii lvad operating manual. , St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility.
US PMA Part Number: IFU00376 Revision: 03 Date: June. The ICCAC is the professional society for MCS Clinicians throughout the world. Heartmate 3™ lvad delivers outstanding survival and safety outcomes at 2 years *, 1 the highest published 2- year survival rate and the lowest published stroke and thrombosis rates for continuous- flow lvads 1- 5. EMS Guide HeartMate II Abbott This guide is produced by ICCAC – The International Consortium of Circulatory Assist Clinicians.