Profile: Thoratec Corp (THOR.O)
28 Jul 2015
Thoratec Corporation, incorporated on March 26, 1976, develops, manufactures and markets medical devices used for mechanical circulatory support for the treatment of heart failure patients. The Company’s products include ventricular assist devices (VADs), such as HeartMate II Left Ventricular Assist System (HeartMate II), HeartMate III Left Ventricular Assist System, Thoratec Paracorporeal Ventricular Assist Device (PVAD) and Thoratec Implantable Ventricular Assist Device (IVAD). For acute circulatory support, the Company’s product lines are CentriMag Acute Circulatory System (CentriMag) and for pediatric patients PediMag/PediVAS Acute Circulatory System (PediMag/PediVAS). HeartMate II, PVAD, IVAD, CentriMag and PediMag/PediVAS are approved by the United States Food and Drug Administration (FDA) and have received Conformite Europeene (CE) mark approval in Europe.
HeartMate III, a centrifugal-flow, chronic, left ventricular assist system, is in the United States Investigational Device Exemption (IDE) and Conformite Europeene mark clinical trials. The HeartMate III United States clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II and includes a primary endpoint of survival free of device replacement and debilitating stroke. In 2014, the trial began enrollment in a safety phase under conditional approval from the FDA for 30 patients at five sites. The trial provides that the first 294 randomized patients will be followed for six months to evaluate a short-term indication, such as bridge-to-transplantation. The first 366 randomized patients will be followed for 24 months to evaluate a long-term indication, such as destination therapy. The trial also allows for approximately 600 additional randomized patients to be enrolled beyond the pivotal cohort in order to assess secondary endpoints. In 2014, 50 patients were enrolled in the CE mark trial at ten locations in Europe, Central Asia, Canada and Australia.
HeartMate II is an implantable, electrically powered, continuous flow, left ventricular assist device (LVAD) consisting of a rotary blood pump designed to provide intermediate and long-term mechanical circulatory support (MCS). HeartMate II has received United States Food and Drug Administration (FDA) approval for bridge-to-transplantation (BTT) and received FDA approval for use in HF patients who are not eligible for heart transplantation.
The CentriMag is an extracorporeal circulatory support device that provides hemodynamic stabilization in patients in need of cardiopulmonary support. The CentriMag pump is electronically driven, centrifugal pump based on bearingless motor technology. CentriMag is cleared by the FDA for use up to six hours in patients requiring short-term extracorporeal circulatory support during cardiac surgery. Additionally, CentriMag is approved under an FDA humanitarian device exemption (HDE) to be used as a right ventricular assist device for periods of support up to 30 days in patients in cardiogenic shock due to acute right ventricular failure. The device is marketed in Europe to provide support for up to thirty days for both cardiac and respiratory failure.
PediMag and PediVAS are similar, extracorporeal full-flow acute surgical support platforms incorporating a polycarbonate pump based on magnetically levitated bearingless motor technology, which provides acute surgical support to pediatric patients. PediMag is cleared by the FDA for use, in conjunction with the CentriMag console and motor, for support periods of up to six hours. Outside the United States, the device is branded as PediVAS. This device has been CE marked for marketing in Europe to provide support for up to 30 days for both cardiac and respiratory failure.
PVAD is an external, pulsatile VAD, which is FDA-approved for BTT and post-cardiotomy myocardial recovery. PVAD is a paracorporeal device that is less invasive than implantable VADs since only the cannula are implanted. The paracorporeal nature of PVAD provides several benefits, including shorter implantation times and the ability to use the device in smaller patients. PVAD is designed for short-to-intermediate duration for post-cardiotomy myocardial recovery following cardiac surgery and BTT. PVAD and IVAD offer left, right or biventricular support for use for BTT.
IVAD is an implantable, pulsatile, VAD, which is FDA-approved for BTT, including home discharge, and post-cardiotomy myocardial recovery and provides left, right or biventricular MCS. IVAD maintains the same blood flow path, valves and blood pumping mechanism as PVAD, but has an outer housing made of a titanium alloy that makes it suitable for implantation.
The Company competes with Aachen Innovative Solutions GmbH, AbioMed, Inc., Berlin Heart GmbH, HeartWare International Inc., Jarvik Heart, Inc., Maquet Cardiovascular, LLC (a division of Getinge AB), ReliantHeart, Inc., Sun Medical Technology Research Corporation, SynCardia Systems, Inc., and Terumo Heart, Inc.
6035 Stoneridge Dr
PLEASANTON CA 94588