Profile: Thoratec Corp (THOR.O)
Thoratec Corporation, incorporated in 1976, is engaged in mechanical circulatory support with a product portfolio to treat the range of clinical needs for advanced heart failure (HF) patients. The Company develops, manufactures and markets medical devices used for circulatory support. For advanced HF, its primary product lines are its ventricular assist devices (VADs), which include the Thoratec Paracorporeal Ventricular Assist Device (PVAD), the Thoratec Implantable Ventricular Assist Device (IVAD), the HeartMate Left Ventricular Assist System (HeartMate XVE), and the HeartMate II Left Ventricular Assist System (HeartMate II). For acute HF, its product lines are the CentriMag Acute Circulatory System (CentriMag) and for pediatric patients the PediMag/PediVAS Acute Circulatory System (PediMag/PediVAS). The PVAD, IVAD, HeartMate XVE, HeartMate II, CentriMag and PediMag/PediVAS are approved by the United States Food and Drug Administration (FDA), and Conformite Europeene (CE) Mark approved in Europe. On August 3, 2011, the Company acquired Levitronix LLC (Levitronix). During the year ended December 31, 2011, the Company discontinued the sale of the HeartMate XVE.
The HeartMate II
The HeartMate II is an implantable, electrically powered, continuous flow, left ventricular assist device consisting of a rotary blood pump designed to provide intermediate and long-term MCS. Its HeartMate external peripherals (GoGear), including batteries, charger and power module, which are designed to provide life for HeartMate patients by providing them to resume many aspects of a normal lifestyle.
The Paracorporeal Ventricular Assist Device
The PVAD is an external, pulsatile, ventricular assist device, FDA approved for bridge-to-transplantation (BTT), including home discharge, and post-cardiotomy myocardial recovery and provides left, right and biventricular MCS. The PVAD is a paracorporeal device that is less invasive than implantable VADs since only the cannula is implanted. The paracorporeal nature of the PVAD has several benefits, including shorter implantation times (approximately two hours) and the ability to use the device in smaller patients.
The Implantable Ventricular Assist Device
The IVAD is an implantable, pulsatile, ventricular assist device FDA approved for BTT, including home discharge, and post-cardiotomy myocardial recovery and provides left, right or biventricular MCS. The IVAD maintains the same blood flow path, valves and blood pumping mechanism as the PVAD, but has an outer housing made of a titanium alloy that makes it suitable for implantation.
The CentriMag is an extracorporeal full-flow acute surgical support platform incorporating a polycarbonate pump. The CentriMag is 510(k) 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 to be used as a right ventricular assist device for periods of support up to thirty days in patients in cardiogenic shock due to acute right ventricular failure.
The PediMag and PediVAS are identical, extracorporeal full-flow acute surgical support platforms incorporating a polycarbonate pump, based on magnetically levitated bearingless motor technology, designed to provide acute surgical support to pediatric patients. The brand names differ according to indication for use, duration of support, and regulatory approval. The PediMag is 510(k) cleared by the FDA for use, in conjunction with the CentriMag console and motor, for support periods of up to six hours. An Investigational Device Exemption (IDE) has been submitted to the FDA in order to begin a United States clinical trial examining the safety and probable benefit of the device for use up to 30 days to support pediatric patients. Outside the United States, the device is branded as PediVAS and has CE Mark approval for support durations of up to 30 days for both cardiac and respiratory failure. In Canada, PediVAS is approved for short cardiopulmonary support or extracorporeal life support.
The Company competes with Terumo Heart, Inc., HeartWare International Inc., AbioMed, Inc., Jarvik Heart, Inc., MicroMed Technology, Inc., SynCardia Systems, Inc., CirculLite, Aachen Innovative Solutions GmbH, WorldHeart Corporation and Berlin Heart GmbH.
6035 Stoneridge Drive
Pleasanton CA 94588