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Thoratec ® PVAD? & Thoratec ® IVAD?

Thoratec ® PVAD? & Thoratec ® IVAD?

Thoratec ® PVAD? & Thoratec ® IVAD?

Product catalog summary
About PVAD: The Thoratec PVAD (Paracorporeal Ventricular Assist Device) is designed for advanced heart failure patients needing left, right, or bi-ventricular support. It is suitable for acute to intermediate support and allows for home discharge. It is approved in the U.S. for Bridge-to-Transplantation and Post-Cardiotomy Recovery.
About IVAD: The Thoratec IVAD (Implantable Ventricular Assist Device) is an implantable version of the PVAD, offering biventricular support for intermediate to chronic needs. It is the only implantable option for such support in the U.S.
PVAD & IVAD Systems: Both systems include a blood pump, cannulae, and a pneumatic driver. They provide circulatory assistance when the heart cannot maintain adequate circulation. Over 8,400 devices have been used in 5,600 patients worldwide.
TLC-II Portable VAD Driver: This device enhances patient mobility and quality of life by powering the PVAD and IVAD devices. It is lightweight and approved for use in hospitals, homes, and during travel.
Current Indications: The devices are approved for Bridge-to-Transplantation, Post-Cardiotomy Recovery, and Home Discharge, allowing patients to await heart transplantation or recovery at home.
Benefits: Key benefits include biventricular support, home discharge capability, support from acute to chronic stages, suitability for smaller patients, and use of biocompatible materials like Thoralon®.
How it Works: The PVAD system operates by allowing blood flow from the heart to the PVAD and back to the body, using a sensor to adjust the pumping rate. The IVAD functions similarly but is implanted in the chest cavity.
Device Longevity and Approval: The PVAD is approved for days to years of support, with FDA approval for Bridge-to-Transplantation and Post-Cardiotomy Recovery. The IVAD is similarly approved, with CE mark authorization.
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Catalog excerpts

Thoratec ® PVAD? & Thoratec ® IVAD?-1

Susan Benton Russell Phone: 310.697.3488 [email protected] Thoratec ® PVAD™ & Thoratec ® IVAD™ Fact Sheet About PVAD: The Thoratec PVAD (Paracorporeal Ventricular Assist Device) provides maximum versatility for physicians in meeting the left, right or bi-ventricular support needs of advanced heart failure patients requiring acute (weeks) or intermediate (months) support with the opportunity for home discharge. With more than 20 years of clinical use, the PVAD can support a wide range of patients with advanced heart failure. The device is approved in the U.S. for Bridge-to-Transplantation (BTT) and Post-Cardiotomy Recovery from open-heart surgery. About IVAD: The Thoratec IVAD (Implantable Ventricular Assist Device) is based on the reliable and clinically established Thoratec PVAD. The result is an implantable VAD with proven technology that can support an extensive array of patients. The IVAD is the only implantable biventricular support option for advanced heart failure patients requiring intermediate (months) or chronic (years) support. PVAD & IVAD Systems: Each PVAD and IVAD system includes three major components: Blood pump, Cannulae and Pneumatic Driver (Dual Drive Console or TLC-II® Portable VAD Driver).This system offers partial or total circulatory assistance when the heart cannot maintain adequate circulation to the body. Today, more than 8,400 Thoratec PVAD and IVAD devices have been used in the treatment of nearly 5,600 patients across more than 260 medical centers worldwide. TLC-II® Portable VAD Driver: To improve patient mobility and patient quality of life, Thoratec developed the TLC-II Portable VAD Driver, an electromechanical device that pneumatically powers the PVAD and IVAD devices. This driver is a compact and lightweight (9.8 kg/20 lbs) unit that allows easier patient movement and increased portability. In Europe and North America, it is approved for use in the hospital and discharge setting including a patient’s home. This enables patients to be discharged from the hospital while awaiting heart transplantation or recovery of the natural heart. For greater convenience, the TLC-II is also approved for both ground and air travel, which includes helicopter and fixed-wing aircraft.

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Thoratec ® PVAD? & Thoratec ® IVAD?-2

Thoratec Press Kit: PVAD, IVAD Fact Sheet, Page 2 of 3 Current Indications: Bridge-to-Transplantation. The Thoratec PVAD and IVAD are approved for Bridge-to-Transplantation, keeping critically ill patients alive until donor hearts become available. Post-Cardiotomy Recovery. Open-heart surgery patients sometimes have difficulty being weaned off bypass machines, and a VAD can provide much needed rest to the heart while it recovers. Home Discharge. The Thoratec PVAD and IVAD are the first and only biventricular support systems that are approved for home discharge, allowing patients to be discharged...

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Thoratec ® PVAD? & Thoratec ® IVAD?-3

Thoratec Press Kit: PVAD, IVAD Fact Sheet, Page 3 of 3 Manufactured and supported by Thoratec. As the industry leader in mechanical circulatory support (MCS) for advanced heart failure patients, Thoratec is committed to providing extensive programs and services, including reimbursement support, education and training, clinical support and product and technical support. The pulsatile Thoratec PVAD System works by allowing blood to flow from the natural heart to the PVAD, outside the body, through an implanted atrial or ventricular cannula. It then pumps blood back to the body through another implanted...

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