Thoratec produces the Thoratec VAD and HeartMate LVAD

Circulatory Support Products Commercially Available in United States

HeartMate II® Left Ventricular Assist System (LVAS)
The Thoratec HeartMate II Left Ventricular Assist Device (LVAD) is a miniaturized mechanical circulatory support (MCS) device intended for a broad range of advanced-stage heart failure patients. HeartMate II is designed to restore blood flow, improve survival, functional status, and quality of life. Based on the impressive clinical outcomes of the landmark HeartMate II clinical trial initiated in 2005, the HeartMate II received FDA approval in April 2008 for Bridge-to-Transplantation.

HeartMate® Left Ventricular Assist System (LVAS)
The HeartMate LVAS is available as either a Vented Electric (XVE) or an Implantable Pneumatic (IP) LVAD. Both devices are approved as a bridge to transplantation. The HeartMate XVE is also approved for use as Destination Therapy for patients that are not transplant eligible*. Both LVADs are designed to assist the pumping function of the left ventricle of the natural heart and feature a unique textured blood-contacting surface that eliminates the need for systemic anticoagulation.

Thoratec® Ventricular Assist Device (VAD) System
Designed for versatility, the paracorporeal Thoratec VAD System can provide left, right, or biventricular support to patients of almost any size. It is approved for use both as a bridge-to-transplantion and for post-cardiotomy recovery from open-heart surgery. The portable TLC-II® Driver is now available in the U.S. and is designed to power the Thoratec VAD System for ambulatory patients.

Thoratec® Implantable Ventricular Assist Device (IVAD™) System
The Thoratec IVAD is now FDA approved for use in bridge-to-transplantation and post-cardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The IVAD is the only currently approved, implantable cardiac assist device that can provide left, right or biventricular support. It has been approved for use in Europe for over a year. The IVAD's compact size facilitates BiVAD implants and enables it to accommodate a wide range of patients, including those who were previously unable to receive an implantable, pulsatile device.

Vascular Graft Products Commercially Available in United States

Vectra® Vascular Access Graft (VAG)
The Vectra VAG is a self-sealing graft designed and clinically tested to allow for hemodialysis use within 24 hours of surgical implantation. The Vectra's compliant, self-sealing design also decreases bleeding time after needle removal.

Products Available through International Technidyne Corporation (ITC)

International Technidyne (ITC)
Our ITC subsidiary is a world leader in the fields of hemostasis management and point-of-care testing with over 30 years of knowledge and experience. ITC devices are reliable, easy to use, and enjoy significant brand recognition as a result of their product superiority. ITC instruments and disposables are used in areas requiring point-of-care or near patient monitoring: Cardiac Surgery and Interventional procedures, Critical Care and Alternate Site areas, including Physician Offices, Clinics and Patient Self-Testing. ITC is committed to helping patients and improving quality of life through innovation and technological advancements.

ITC develops, manufactures and markets products in four distinct categories: HEMOCHRON® point-of-care coagulation instruments and reagents; IRMA® Blood Analysis System for blood gas and electrolyte testing; skin incision products including tenderfoot®, Tenderlett® and Surgicutt®; and the ProTime® Microcoagulation System for prothrombin time testing at home and for professional use. For more information please visit www.itcmed.com.

*NYHA Class IV patients with end-stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, who have a life expectancy of less than two years, and who are not candidates for cardiac transplantation.