Thoratec

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Thoratec Corporation
Subsidiary
Industry Medical devices
Founded California, U.S.(March 1, 1976 (1976-03-01))
Headquarters Pleasanton, California
Area served
 Global
Key people
 D. Keith Grossman
President and CEO
Products mechanical circulatory support devices
Revenue Decrease US$ 477.6 million (2014)[1]
Decrease US$ 69.9 million (2014)[1]
Number of employees
 1,048 (2014)[1]
Parent St. Jude Medical
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]

For chronic circulatory support for late-stage heart-failure patients, Thoratec's primary product lines are its ventricular assist devices: the HeartMate II Left Ventricular Assist System (HeartMate II), 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.

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.

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]

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 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]

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 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.[11][4] 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.[48][51][47][49][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 major products include:

  • HeartMate II. The HeartMate II is a continuous-flow left ventricular assist device (LVAD) implanted alongside a patient’s native heart with the purpose of pumping for the heart’s left ventricle. It is surgically implanted just below the diaphragm in the abdomen and attached to the aorta, leaving natural circulation in place as it assists in providing energy to propel blood throughout the body as a healthy left ventricle would. It is designed to have a longer functional life than the previous generation of devices and to operate more quietly. Patients with the HeartMate II can be discharged from the hospital and the portability of the device’s components makes it easier for the patient to remain active. The FDA approved the HeartMate II for bridge-to-transplantation therapy in April 2008 and for destination therapy in January 2010.[66][67][23][25]
  • PVAD (Paracorporeal Ventricular Assist Device). The Thoratec PVAD is an external, pulsatile, ventricular assist device, FDA-approved for bridge-to-transplantation, including home discharge, and post-cardiotomy recovery. It provides left, right, or biventricular support.[68]
  • CentriMag. The CentriMag blood pump is an extracorporeal circulatory support device providing hemodynamic stabilization in patients in need of cardiopulmonary support. It is cleared for clinical use up to six hours, and can be used as a short-term solution to support the circulation while longer-term options are considered. It is approved for use as a right ventricular assist device (RVAD) for periods of support up to 30 days for patients in cardiogenic shock due to acute right ventricular failure.[69]
  • PediMag. The PediMag blood pump, known as PediVAS outside the U.S., is an extracorporeal circulatory support device providing hemodynamic stabilization for pediatric patients in need of cardiopulmonary assistance. It is cleared for clinical use up to six hours, and can be used as a short-term solution to support the circulation while longer-term options are considered.[70]

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.[71][72][46]

References

  1. ↑ 1.0 1.1 1.2 2014 Annual Report. Thoratec Corporation. Retrieved October 10, 2015.
  2. ↑ "Thoratec, A Bio Stock With Good Potential And Products". Seeking Alpha. May. 23, 2013.
  3. ↑ "Research and Markets: Global Ventricular Assist Devices (VAD) Market 2015-2019 with Abiomed, HeartWare International & Thoratec Dominating". Yahoo! Finance. February 18, 2015.
  4. ↑ 4.00 4.01 4.02 4.03 4.04 4.05 4.06 4.07 4.08 4.09 4.10 4.11 4.12 4.13 4.14 Cowell, Jeffrey L. "Thoratec Corporation". In: Pederson, Jay P. (ed). International Directory of Company Histories, Vol. 122. St. James Press, 2011. pp. 447–450.
  5. ↑ Thoratec Corporation Fact Sheet. Thoratec.com. Retrieved April 8, 2015.
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ Ratner, Buddy D.; Hoffman, Allan S.; Schoen, Frederick J.; Lemons, Jack E. Biomaterials Science: An Introduction to Materials in Medicine. Academic Press, 2004. p. 496.
  8. ↑ Rodriguez, Heron E.; Pearce, William H.; Yao, James S. T. The Ischemic Extremity: New Findings and Treatment. People's Medical Publishing House–USA, 2010. p. 399.
  9. ↑ Form 10-Q for THORATEC CORP: Quarterly Report, "ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS". November 6, 2014. Yahoo! Finance. 2014.
  10. ↑ Thoratec PVAD & Thoratec IVAD Fact Sheet Thoratec Corporation. Retrieved April 20, 2015.
  11. ↑ 11.0 11.1 Menkes, Justin. Executive Intelligence. Harper Collins, 2009. p. 9.
  12. ↑ "Landmark Clinical Trial At 22 Medical Centers Finds Implanted Heart Pumps Lengthen And Improve Lives Of Terminally Ill Heart Failure Patients". Columbia University Medical Center. November 12, 2001.
  13. ↑ American Society of ExtraCorporeal Technology. "VE LVAS for End-Stage Heart Failure". Perfusion.com. September 1, 2004.
  14. ↑ "FDA approves use of improved HeartMate XVE for destination therapy". Heart Disease Weekly. May 11, 2003.
  15. ↑ Thoratec Corporation. Thoratec Corporation 2010 Annual Report. Securities and Exchange Commission. Morningstar.com. Retrieved April 8, 2015.
  16. ↑ 16.0 16.1 Thoratec Corporation: 2005 Annual Report. Thoratec Corporation. 2006. p. 6.
  17. ↑ "Thoratec: FDA approval for TLC-II Portable Ventricular Assist Device". The BBI Newsletter. February 1, 2004.
  18. ↑ Peura, Jennifer, M.D. "MUSC VAD Program: Only Center in South Carolina Offering Destination Therapy". In: Progress Notes. Medical University of South Carolina. November 2010. p. 2.
  19. ↑ Ziemba, Stanley. "New hope for failing hearts". Chicago Tribune. April 13, 2005.
  20. ↑ "VAD Therapies for Wide Range of Cardiac Conditions". Cardiovascular Center Update, Spring 2007. Brigham and Women's Hospital. Retrieved April 8, 2015.
  21. ↑ Winslow, Ron. "Giving a Heart a Hand: A New Mechanical Pump Offers Heart-Failure Patients an Alternative to a Transplant". Wall Street Journal. December 16, 2009.
  22. ↑ HeartMate II Left Ventricular Assist System: Clinical Operation and Patient Management. Thoratec Corporation, May 25, 2011. p. 3.
  23. ↑ 23.0 23.1 HeartMate II Left Ventricular Assist Device (LVAD) Fact Sheet. Thoratec.com. Retrieved April 8, 2015.
  24. ↑ Mechcatie, Elizabeth. "HeartMate II approved as destination therapy". Internal Medicine News. March 1, 2010.
  25. ↑ 25.0 25.1 Lua error in package.lua at line 80: module 'strict' not found.
  26. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  27. ↑ Thoratec on the Forbes America's Best Small Company's List. Forbes. 2012.
  28. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  29. ↑ A Clinical Trial to Evaluate the HeartWare Ventricular Assist System (ENDURANCE). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved April 21, 2015.
  30. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  31. ↑ 31.0 31.1 Lua error in package.lua at line 80: module 'strict' not found.
  32. ↑ "Thoratec Announces Acquisition of Innovative Catheter-Based Heart Pump Technology". PR Newswire. January 25, 2010.
  33. ↑ "Deals Roundup: Thoratec Buys Catheter Pump Technology for $8.5M in Cash". Medical Device Daily. January 27, 2010.
  34. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  35. ↑ "VAD Maker Thoratec Acquires Levitronix, Pediatric Device". Diagnostic and Interventional Cardiology. August 5, 2011..
  36. ↑ "Thoratec Announces Acquisition of Medical Business of Levitronix". PR Newswire. August 3, 2011.
  37. ↑ "Thoratec acquires DuraHeart II ventricular assist system". Cardiovascular News. July 15, 2013.
  38. ↑ "Thoratec Acquires DuraHeart II Ventricular Assist System". PR Newswire. July 1, 2013.
  39. ↑ "Deals Roundup: Thoratec Acquires DuraHeart II for Upfront Payment of $13M". Medical Device Daily. July 2, 2013.
  40. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  41. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  42. ↑ Husten, Larry. "4 Deaths Linked To Thoratec Heart System". Forbes. March 4, 2014.
  43. ↑ Laffernis, Tabitha. "Thoratec issues warning about heart pump controller linked to four deaths". Tech Times. March 6, 2014.
  44. ↑ Lee, Stephanie M. "Thoratec warns of heart pump's link to 4 patient deaths". San Francisco Chronicle. March 6, 2014.
  45. ↑ "Thoratec Corp. Creates Worldwide Urgent Medical Device Correction Letter to Update Its Labeling regarding the Use of the HeartMate II LVAS Pocket System Controller". Health & Beauty Close-Up. March 7, 2014
  46. ↑ 46.0 46.1 Crotti, Nancy. "After Patient Deaths, Thoratec Reinstates Former CEO". EE Times. October 2, 2014.
  47. ↑ 47.0 47.1 MOMENTUM 3 IDE Clinical Study Protocol (HM3). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved September 16, 2015.
  48. ↑ 48.0 48.1 "Thoratec Announces First HeartMate 3 Implant in European Less Invasive Surgical Trial". PR Newswire. July 6, 2015.
  49. ↑ 49.0 49.1 "Thoratec Announces Start Of Heartmate III U.S. Clinical Trial". Diagnostic and Interventional Cardiology. September 29, 2014.
  50. ↑ Thoratec HeartMate III Left Ventricular Assist System (LVAS): U.S. IDE Clinical Trial Overview. Thoratec.com. Retrieved April 8, 2015.
  51. ↑ Thoratec Corporation HeartMate III CE Mark Clinical Investigation Plan (HM III CE Mark). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved April 8, 2015.
  52. ↑ "Thoratec Receives Approval From FDA For Full Expansion Of HeartMate III U.S. IDE Clinical Trial". PR Newswire. April 2, 2015.
  53. ↑ HeartMate PHP CE Mark Clinical Investigation Plan (HM PHP CE Mark). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved April 21, 2015.
  54. ↑ Thoratec Corporation Fact Sheet. Thoratec Corporation. Retrieved April 21, 2015.
  55. ↑ "Thoratec Receives CE Mark Approval For HeartMate PHP". PR Newswire. July 13, 2015.
  56. ↑ "Thoratec initiates Shield II US clinical trial of HeartMate PHP". MedicalDevice-Network.com. September 8, 2015.
  57. ↑ "Thoratec Announces Start Of Shield II U.S. Clinical Trial". PR Newswire. September 4, 2015.
  58. ↑ Coronary InterventionS in HIgh-Risk PatiEnts Using a Novel Percutaneous Left Ventricular Support Device (SHIELD II). U.S. National Institutes of Health. ClinicalTrials.gov. Retrieved September 16, 2015.
  59. ↑ "Thoratec Acquires Apica Cardiovascular". PR Newswire. July 2, 2014.
  60. ↑ "Thoratec Acquires Apica Cardiovascular". Cardiac Interventions Today. July 2, 2014.
  61. ↑ Bray, Chad. "St. Jude Medical to Buy Thoratec for $3.4 Billion". New York Times. July 22, 2015.
  62. ↑ "St. Jude Medical and Thoratec Announce Definitive Agreement". MarketWatch. July 22, 2015.
  63. ↑ Carlson, Joe. "St. Jude sees good outlook for Thoratec HeartMate 3". Star Tribune. July 25, 2015.
  64. ↑ "Thoratec Announces End Of 'Go Shop' Period". PR Newswire. August 21, 2015.
  65. ↑ "St. Jude Medical Completes Acquisition of Thoratec". Business Wire. October 8, 2015.
  66. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  67. ↑ HeartMate II Pivotal Clinical Trial Fact Sheet. Thoratec.com. Retrieved April 8, 2015.
  68. ↑ Thoratec PVAD. Thoratec.com. Retrieved April 8, 2015.
  69. ↑ Thoratec CentriMag Blood Pump. Thoratec.com. Retrieved April 8, 2015.
  70. ↑ Thoratec PediMag Blood Pump. Thoratec.com. Retrieved April 8, 2015.
  71. ↑ "Thoratec Appoints D. Keith Grossman President And Chief Executive Officer". PR Newswire. September 22, 2014.
  72. ↑ Leuty, Ron. "Thoratec CEO exits as predecessor enters". San Francisco Business Times. September 22, 2014.

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