First decades Thoratec was incorporated in California in 1976 as Thoratec Laboratories Corporation. It completed its
initial public offering (IPO) of stock in 1981, trading under the ticker "THOR". The company's efforts were focused on developing devices for
circulatory support and
vascular graft applications. The material is currently used in the Thoratec PVAD pulsatile-flow biventricular device. By 2000, the Thoratec VAD System was the only device approved by the FDA for
left,
right, or
biventricular support for both providing a bridge until heart transplant and for recovery of the heart after
open-heart surgery. This acquisition gave Thoratec dominance in the
artificial heart market, and the company also shortened its name from Thoratec Laboratories Corporation to Thoratec Corporation.
HeartMate and other product lines With the 2001 Thermo Cardiosystems merger, Thoratec acquired the HeartMate Left Ventricular Assist System, an implanted VAD for
end-stage heart patients. A landmark three-year study of 129 patients at 22 major medical centers, called REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) and published in November 2001, found that the HeartMate VE (vented electric) more than doubled the likelihood that terminally ill heart-failure patients would be alive at the end of one year, and it increased the likelihood of survival for two years to 22.9% vs. 8.1% for patients who were treated with only medication. By November 2002, the FDA approved the HeartMate VE both for patients awaiting a heart transplant (bridge to transplantation), and for patients too ill to be eligible for a heart transplant (
destination therapy). Thoratec was the first company to gain approval of a VAD for permanent use in patients too ill for a heart transplant. In June 2003 the HeartMate XVE received
CE Mark approval allowing for its commercial sale in Europe, and in June 2004 it was approved in Canada. The company's biventricular VAD, the paracorporeal (external) Thoratec PVAD, had been developed and approved in the 1990s for hospital use in the U.S. In December 2003, the FDA approved the TLC-II portable driver – the unit providing power, monitoring, and operational control for these VADs – for home discharge, making it the first biventricular support device approved for home discharge. This enabled patients to return home with the system to await heart transplantation or for their native heart to recover. HeartMate II was
CE Mark authorized for bridge to transplantation and for destination therapy in Europe in November 2005. It received FDA approval for bridge-to-transplantation (BTT) use in April 2008, and for destination therapy (DT) for those too old or ill for a heart transplant in January 2010. The company therefore discontinued its first-generation HeartMate XVE in 2011. In July 2009, the
Journal of the American College of Cardiology reported on 18-month follow-up data for the HeartMate II Pivotal Study, which showed improved survival, less frequent adverse events, and greater reliability with
continuous-flow LVADs compared to
pulsatile-flow devices. As of mid 2015, Thoratec has the only FDA-approved LVAD for destination therapy, or permanent support; the ventricular assist system by competitor HeartWare Inc. is still in clinical trials for destination therapy. In a two-year randomized controlled clinical trial published in 2009 comparing pulsatile and continuous-flow LVADs, survival rates at two years increased approximately six-fold for HeartMate II patients compared to actuarial survival rates for patients who receive only drug therapy. In the 2005–2007 and 2007–2009 HeartMate II destination-therapy trials, more than 80% of patients implanted with the HeartMate II improved to
NYHA class I/II from NYHA class III/IV by six months after implantation, and this improvement remained stable for two years. The patients' six-minute walk distance improved to >340 meters by six months and was sustained through two years. In August 2011 Thoratec acquired the medical business of Levitronix. The acquisition included CentriMag, an
extracorporeal centrifugal-flow blood pump used for short-term surgical support, and the PediMag, an acute
pediatric surgical circulatory support system known as PediVAS outside the U.S. In July 2013, Thoratec acquired the DuraHeart II ventricular assist system from medical-equipment manufacturer
Terumo. According to the press release, the device further differentiates Thoratec's approach to mechanical circulatory support, and is expected to begin in-human implantation in 2016 followed by clinical trials. A study published in November 2013 by the
New England Journal of Medicine reported an unexpected increase in blood clots (
thrombosis) in the HeartMate II from March 2011 through January 2013 and thereafter, at three institutions. Another analysis at three other institutions including the
Mayo Clinic reported a similar thrombosis increase with a peak in 2012; however thereafter the incidence decreased by 2013 to post-marketing (2007) levels. In March 2014 Thoratec issued a warning against improper use of the external controller for the HeartMate II.
HeartMate 3 introduced Thoratec's third-generation HeartMate LVAD is the HeartMate 3, designed to lower adverse event rates through improved
hemocompatibility, and to increase ease of surgical placement through new design and compact size. It began undergoing clinical trials in the U.S. and internationally in mid 2014. In mid 2014, CE Mark trials also started for the Thoratec PHP (Percutaneous Heart Pump), an external catheter-based left ventricular pump for acute mechanical circulatory support, and the device received CE Mark approval in July 2015. In late 2015 the company initiated a clinical study exploring the use of the Thoratec PHP in patients undergoing high-risk
percutaneous coronary intervention (PCI). In July 2014, Thoratec acquired Apica Cardiovascular Limited. The Ireland-based company developed a number of implant systems and devices designed to enable transapical (through the
apex of the heart) surgical access. In July 2015, it was announced that Thoratec would be acquired by
St. Jude Medical, a global medical-device company headquartered in
Saint Paul, Minnesota. The acquisition was completed in October 2015. ==Major products==