Thoratec

Last updated
Thoratec Corporation
Subsidiary
IndustryMedical devices
Founded California, U.S.(March 1, 1976 (1976-03-01))
Headquarters
Area served
Global
Key people
D. Keith Grossman
President and CEO
Productsmechanical circulatory support devices
Number of employees
1,048 (2014) [1]
Parent St. Jude Medical, LLC
Website Thoratec.com

Thoratec Corporation is a United States-based company that develops, manufactures, and markets proprietary medical devices used for mechanical circulatory support for the treatment of heart-failure patients worldwide. It is a global leader in mechanical circulatory support devices, particularly in ventricular assist devices (VADs). [2] [3]

United States Federal republic in North America

The United States of America (USA), commonly known as the United States or America, is a country comprising 50 states, a federal district, five major self-governing territories, and various possessions. At 3.8 million square miles, the United States is the world's third or fourth largest country by total area and is slightly smaller than the entire continent of Europe. With a population of over 327 million people, the U.S. is the third most populous country. The capital is Washington, D.C., and the most populous city is New York City. Most of the country is located contiguously in North America between Canada and Mexico.

Medical device Equipment designed to aid in the diagnosis, monitoring or treatment of medical conditions

A medical device is any device intended to be used for medical purposes. Thus what differentiates a medical device from an everyday device is its intended use. Medical devices benefit patients by helping health care providers diagnose and treat patients and helping patients overcome sickness or disease, improving their quality of life. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.

Heart failure condition in which the heart is unable to provide sufficient pump action

Heart failure (HF), also known as congestive heart failure (CHF) and congestive cardiac failure (CCF), is when the heart is unable to pump sufficiently to maintain blood flow to meet the body's needs. Signs and symptoms of heart failure commonly include shortness of breath, excessive tiredness, and leg swelling. The shortness of breath is usually worse with exercise or while lying down, and may wake the person at night. A limited ability to exercise is also a common feature. Chest pain, including angina, does not typically occur due to heart failure.

Contents

For chronic circulatory support for late-stage heart-failure patients, Thoratec's primary product lines are its ventricular assist devices: the HeartMate 3 Left Ventricular Assist System (HeartMate 3), and the Thoratec Paracorporeal Ventricular Assist Device (PVAD). For acute circulatory support, the company's product lines are the CentriMag Acute Circulatory System (CentriMag); and for pediatric patients the PediMag Acute Circulatory System, known as PediVAS outside the U.S.

A chronic condition is a human health condition or disease that is persistent or otherwise long-lasting in its effects or a disease that comes with time. The term chronic is often applied when the course of the disease lasts for more than three months. Common chronic diseases include arthritis, asthma, cancer, chronic obstructive pulmonary disease, diabetes and some viral diseases such as hepatitis C and acquired immunodeficiency syndrome. An illness which is lifelong because it ends in death is a terminal illness. It is possible and not unexpected for an illness to change in definition from terminal to chronic. Diabetes and HIV for example were once terminal yet are now considered chronic due to the availability of insulin and daily drug treatment for individuals with HIV which allow these individuals to live while managing symptoms.

Acute care is a branch of secondary health care where a patient receives active but short-term treatment for a severe injury or episode of illness, an urgent medical condition, or during recovery from surgery. In medical terms, care for acute health conditions is the opposite from chronic care, or longer term care.

Incorporated in 1976, Thoratec is headquartered in Pleasanton, California. In 2015 the company was acquired by St. Jude Medical, a global medical-device company headquartered in Saint Paul, Minnesota. In January 2017, St. Jude was acquired by Abbott Laboratories.

Pleasanton, California City in the San Francisco Bay Area

Pleasanton is a city in Alameda County, California, incorporated in 1894. It is a suburb in the San Francisco Bay Area located about 25 miles (40 km) east of Oakland, and 6 miles (9.7 km) west of Livermore. The population was 70,285 at the 2010 census. In 2005 and 2007, Pleasanton was ranked the wealthiest middle-sized city in the United States by the Census Bureau. Pleasanton is home to the headquarters of Safeway, Workday, Ellie Mae, Roche Molecular Diagnostics, Blackhawk Network Holdings, and Veeva Systems. Other major employers include Kaiser Permanente, Oracle, Nordstrom and Macy's. Although Oakland is the Alameda County seat, a few county offices are located in Pleasanton. The Alameda County Fairgrounds are located in Pleasanton, where the county fair is held during the last week of June and the first week of July. Pleasanton Ridge Regional Park is located on the west side of town.

St. Jude Medical, Inc. was an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company had more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries. Its major markets include the United States, Europe, Latin America and Asia-Pacific. The company was named after Jude the Apostle, the patron saint of lost causes.

Saint Paul, Minnesota Capital of Minnesota

Saint Paul is the capital and second-most populous city of the U.S. state of Minnesota. As of 2018, the city's estimated population was 307,695. Saint Paul is the county seat of Ramsey County, the smallest and most densely populated county in Minnesota. The city lies mostly on the east bank of the Mississippi River in the area surrounding its point of confluence with the Minnesota River, and adjoins Minneapolis, the state's largest city. Known as the "Twin Cities", the two form the core of Minneapolis–Saint Paul, the 16th-largest metropolitan area in the United States, with about 3.6 million residents.

History

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". [4] [5] The company's efforts were focused on developing devices for circulatory support and vascular graft applications. [4] It developed bypass grafts, which are artificial coronary conduits used in heart surgeries; and eventually also ventricular assist devices (VADs), heart-pump devices for people suffering from congestive heart failure. [4] VADs are used in patients too old or ill for a heart transplant, or to keep a patient alive until a heart becomes available for transplantation surgery. [4]

Initial public offering (IPO) or stock market launch is a type of public offering in which shares of a company are sold to institutional investors and usually also retail (individual) investors. An IPO is underwritten by one or more investment banks, who also arrange for the shares to be listed on one or more stock exchanges. Through this process, colloquially known as floating, or going public, a privately held company is transformed into a public company. Initial public offerings can be used to raise new equity capital for companies, to monetize the investments of private shareholders such as company founders or private equity investors, and to enable easy trading of existing holdings or future capital raising by becoming publicly traded.

Coronary circulation circulation of blood in the blood vessels of the heart muscle (myocardium)

Coronary circulation is the circulation of blood in the blood vessels that supply the heart muscle (myocardium). Coronary arteries supply oxygenated blood to the heart muscle, and cardiac veins drain away the blood once it has been deoxygenated. Because the rest of the body, and most especially the brain, needs a steady supply of oxygenated blood that is free of all but the slightest interruptions, the heart is required to function continuously. Therefore its circulation is of major importance not only to its own tissues but to the entire body and even the level of consciousness of the brain from moment to moment. Interruptions of coronary circulation quickly cause heart attacks, in which the heart muscle is damaged by oxygen starvation. Such interruptions are usually caused by ischemic heart disease and sometimes by embolism from other causes like obstruction in blood flow through vessels.

A vascular bypass is a surgical procedure performed to redirect blood flow from one area to another by reconnecting blood vessels. Often, this is done to bypass around a diseased artery, from an area of normal blood flow to another relatively normal area. It is commonly performed due to inadequate blood flow (ischemia) caused by atherosclerosis, as a part of organ transplantation, or for vascular access in hemodialysis. In general, someone's own vein (autograft) is the preferred graft material for a vascular bypass, but other types of grafts such as polytetrafluoroethylene (Teflon), polyethylene terephthalate (Dacron), or a different person's vein (allograft) are also commonly used. Arteries can also serve as vascular grafts. A surgeon sews the graft to the source and target vessels by hand using surgical suture, creating a surgical anastomosis.

In December 1995 Thoratec received FDA approval to sell its Thoratec Ventricular Assist Device System, an external blood pump with cannulae connecting the pump to the patient's heart and vessels. [4] In 1996 this VADS was used in more than 750 patients, and Thoratec sold 285 of them in clinical trials for the FDA. [4] Company revenues that year were $7.5 million. [4]

Blood pump

The blood pump was patented in 1855 by Porter and Bradley and was hand operated. A modification first named surgical pump, designed and manufactured by E. E. Allen in 1887, was intended for direct blood transfusion. Truax, who also distributed and promoted the Allen pump with one roller, developed the first double roller pump in 1899. In the following decades, several researchers, including Beck, Van Allen, Bayliss and Müller as well as Henry and Jouvelet, refined the apparatus and recommended the use of roller pumps for blood transfusion and other applications. After further modifications made by DeBakey in 1934, and application of this pump in one of the first heart-lung machines constructed by Gibbon, DeBakey's name became inseparably attached to this type of pump. For perfusion experiments, an electrically powered roller pump was first used by Fleisch in 1935. Today, the roller pump is the most frequently used blood pump for cardiopulmonary bypass worldwide, having prevailed against the early pulsatile tube compression pumps and ventricular pumps. In recent years, centrifugal pumps have increasingly competed with roller pumps as systemic blood pumps for cardiopulmonary bypass and have become the preferred arterial pump in a variety of centers. Application of mechanical cardiac assistance has evolved from nonpulsatile roller pump support, followed by an era of pulsatile ventricular pumps to the rediscovery of the nonpulsatile flow mode with modern axial flow pumps.

In its early decades the company also developed Thoralon, a proprietary biocompatible material that minimizes blood clotting and inflammation. [6] [7] [8] The material is currently[ when? ] used in the Thoratec PVAD pulsatile-flow biventricular device. [9] [10]

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. [4] To expand and diversify its product line and capabilities, in 2001 Thoratec acquired Thermo Cardiosystems, a rival company three times its size and the developer of the HeartMate VAD. [4] [11] This acquisition gave Thoratec dominance in the artificial heart market, and the company also shortened its name from Thoratec Laboratories Corporation to Thoratec Corporation. [4]

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. [12]

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). [13] Thoratec was the first company to gain approval of a VAD for permanent use in patients too ill for a heart transplant. [4] The company introduced an enhanced version of the device, the HeartMate XVE, and it was FDA approved for destination therapy in May 2003, having previously been approved for bridge to transplantation. [14] 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. [15]

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. [16] [17] This enabled patients to return home with the system to await heart transplantation or for their native heart to recover. [16]

HeartMate II and later products

Thoratec next developed a second-generation LVAD product line, a continuous-flow VAD called HeartMate II. The new device, one-fifth the size of the HeartMate XVE, was designed to last more than twice as long as the XVE, providing mechanical circulatory support for three to five years or more before replacement. [18] [19] [20] [21] HeartMate II was CE Mark authorized for bridge to transplantation and for destination therapy in Europe in November 2005. [22] 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. [23] [24] [25] [26] The company therefore discontinued its first-generation HeartMate XVE in 2011. [27]

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. [28] 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. [29] 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. [30] 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. [31] The patients' six-minute walk distance improved to >340 meters by six months and was sustained through two years. [31]

In January 2010 Thoratec acquired catheter-based heart pump technology from the Swedish medical-technology company Getinge. The technology is for use in a minimally invasive, acute cardiac axial-flow pump that can be delivered percutaneously in a cardiac catheterization lab or operating room. [32] [33] [34]

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. [35] [36] 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. [37] [38] [39]

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. [40] 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. [41] In March 2014 Thoratec issued a warning against improper use of the external controller for the HeartMate II. [42] [43] [44] [45] [46]

HeartMate 3 introduced

Thoratec's third-generation HeartMate LVAD is the HeartMate 3, [47] [48] designed to lower adverse event rates through improved hemocompatibility, and to increase ease of surgical placement through new design and compact size. [49] [50] It began undergoing clinical trials in the U.S. and internationally in mid 2014. [47] [48] [49] [51] [52]

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, [53] [54] and the device received CE Mark approval in July 2015. [55] 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). [56] [57] [58]

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. [59] [60]

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. [61] [62] [63] [64] The acquisition was completed in October 2015. [65]

Major products

Thoratec's current[ when? ] major products include:

Corporate governance

D. Keith Grossman, with degrees in life sciences and business and a career in the medical industry, joined Thoratec as president and CEO in January 1996. [4] He focused on making a commercial success of the Thoratec VAD System, and he diversified and expanded the company's product line by initiating the acquisition of Thermo Cardiosystems. [4] [11] After reviving the company's profitability, Grossman left Thoratec in 2006 as the company was bringing the HeartMate II to market. [4] He was replaced as president and CEO in January 2006 by Gerhard F. Burbach, formerly president and CEO of the cardiology and radiology company Digirad Corporation. [4] In September 2014, Burbach stepped down and was replaced by his predecessor, D. Keith Grossman. [46] [71] [72]

Related Research Articles

Artificial heart Medical device

An artificial heart is a device that replaces the heart. Artificial hearts are typically used to bridge the time to heart transplantation, or to permanently replace the heart in case heart transplantation is impossible. Although other similar inventions preceded it from the late 1940s, the first artificial heart to be successfully implanted in a human was the Jarvik-7 in 1982, designed by a team including Willem Johan Kolff and Robert Jarvik.

AbioCor was a total artificial heart (TAH) developed by the Massachusetts-based company AbioMed. It was fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer. The AbioCor ran on a rechargeable source of power. The internal battery was charged by a transcutaneous energy transmission (TET) system, meaning that no wires or tubes penetrated the skin, reducing the risk of infection. However, because of its size, this heart was only compatible with men who had a large frame. It had a product life expectancy of 18 months.

Ventricular assist device

A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of VADs is different from that of artificial cardiac pacemakers; some are for short-term use, typically for patients recovering from myocardial infarction and for patients recovering from cardiac surgery; some are for long-term use, typically for patients suffering from advanced heart failure.

Gerson "Gus" Rosenberg, Ph.D., is an American biomedical engineer. He is the Jane A. Fetter Professor of Surgery, professor of bioengineering, and chief of the Division of Applied Biomedical Engineering at Penn State's Milton S. Hershey Medical Center and Penn State College of Medicine.

William S. Pierce is the cardiothoracic surgeon and chemical engineer who led development of the first pneumatic heart assist pump. The Pierce-Donachy Ventricular Assist Device, also known as the Penn State Assist Pump, was designated an International Historic Mechanical Engineering Landmark by the American Society of Mechanical Engineers in 1990.

O. H. "Bud" Frazier is a heart surgeon and director of cardiovascular surgery research at the Texas Heart Institute (THI), best known for his work in mechanical circulatory support (MCS) of failing hearts using left ventricular assist devices (LVAD) and total artificial hearts (TAH).

Peer Michael Portner was a heart researcher whose work led to the development of the ventricular assist device, an electrical pump that permits patients in heart failure to survive until a heart transplant could be performed.

Management of heart failure requires a multimodal approach. It involves a combination of lifestyle modifications, medications, and possibly the use of devices or surgery.

The Hemopump was designed to allow for temporary support of a failing heart. It is a continuous flow pump, and does not need to be synced to the rhythm of the heart. It assists in temporary heart stimulation with conditions such as cardiogenic shock following acute myocardial infarction, heart failure from cardiopulmonary bypass, and more. The pump can continually monitor the left ventricle, which allows for perpetual observation of the hearts condition. This allows for any necessary changes to be made when needed. The pump operates at speeds between two hundred and ninety and four hundred and seventy revolutions per minute.

Destination therapy is a therapy that is final rather than being a transitional stage until another therapy—thus, in transportation metaphor, a destination in itself rather than merely a bridge or road to the destination. The term usually refers to ventricular assist devices or mechanical circulatory support to keep the existing heart going, not just until a heart transplant can occur, but for the rest of the patient's life expectancy. It is thus a course of treatment for severe heart failure patients who are not likely candidates for transplant. In contrast, bridge-to-transplant therapy is a way to stay alive long enough, and stay healthy enough, to await transplant while maintaining eligibility for transplant.

Impella is a family of medical devices used as a temporary ventricular support device in people with depressed heart function. Some versions of the device can provide right heart support during other forms of mechanical circulatory support including ECMO and Centrimag.

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Berlin Heart GmbH is a German company that develops, produces and markets ventricular assist devices (VADs). The devices mechanically support the hearts of patients with end-stage heart failure. Berlin Heart's products include the implantable INCOR VAD and the paracorporeal EXCOR VAD. To date, Berlin Heart produces the only device of its kind available for babies and children with severe heart failure.

Dallas W. Anderson is a businessman who founded MicroMed Technology Inc. in 1995, and in 1996 was granted exclusive rights to the NASA/DeBakey VAD.

Pump thrombosis (PT) is considered a specific case of a major device malfunction, and is classified as either suspected or confirmed pump thrombus. Typically, the device is an implanted blood pump such as a Left ventricular assist device. The malfunction is a blockage in the flow of blood anywhere along a vessel and it is mainly due to the bio-incompatible presence of a fairly complex mechanical apparatus. Pump thrombus is dreaded complication of CF LVAD technology that can require repeat surgery to replace the pump or lead to death.

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