St. Jude Medical

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St. Jude Medical
Type Publicly traded
Traded as NYSESTJ
S&P 500 Component
Industry Medical devices
Founded Saint Paul, Minnesota, 1976
Founder(s) Manuel A. Villafana
Headquarters Saint Paul, Minnesota
Area served Worldwide
Key people Daniel J. Starks, Chairman, President and Chief Executive Officer
John C. Heinmiller, Executive Vice President
Michael T. Rousseau, Chief Operating Officer
Donald J. Zurbay, Vice President, Finance and Chief Financial Officer
Products Cardiac rhythm management devices
Implantable cardioverter-defibrillators
Neuromodulation devices
Operating income $5.5 billion (2013) Increase[1]
Total assets $10.248 billion (2013) Increase[1]
Total equity $4.4 billion (2013) Increase[1]
Employees 16,000[2]

St. Jude Medical, Inc. (NYSESTJ) is a global medical device company headquartered in Saint Paul, Minnesota, United States. The company has more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries.[2][3] Its major markets include the United States, Europe, Latin America and Asia-Pacific. The company is named after Jude the Apostle, the patron saint of lost causes.[3]

St. Jude Medical was founded in 1976 and went public in 1977.[3][4] The company has been listed in the Fortune 500 every year since 2010.[5] Daniel Starks serves as the company's chairman, president and chief executive officer.[6]

History[edit]

Early history[edit]

St. Jude Medical was founded in 1976 to further develop bi-leaflet artificial heart valves, which were originally created in 1972 at the University of Minnesota.[3][4] St. Jude Medical's bi-leaflet valve was developed in large part by Dr. Demetre Nicoloff of the University of Minnesota and St. Jude Medical employee Don Hanson.[4]

Company founder Manny Villafana took St. Jude Medical public in February 1977.[3] In October of that year, Dr. Nicoloff implanted the company's first artificial heart valve in a human patient.[4] St. Jude Medical's new heart valve was coated in pyrolytic carbon, which helped the valve prevent blood clotting.[3][4]

St. Jude Medical founding chief operating officer LaVerne Rees became chief executive officer in 1981.[7] Shortly after his appointment as St. Jude Medical CEO, Rees directed the company to begin development of its own carbon coating.[3] This decision led to a legal battle with CarboMedics, the sole supplier of carbon coating for the company's heart valves.[8] The St. Jude Medical board reassigned Rees in late 1984 after the legal dispute continued.[3][9]

In 1985, Lawrence Lehmkuhl replaced Rees as president and CEO of St. Jude Medical.[10] Lehmkuhl had previously served as a division president at American Hospital Supply Corporation.[10] Shortly after the appointment, St. Jude Medical settled its lawsuit with CarboMedics.[11] The two companies also entered into an agreement that allowed St. Jude Medical to continue developing and producing limited quantities of its own carbon coating.[3]

In 1986, the first St. Jude Medical heart valve created with the company’s own carbon coating technology was implanted into a human in Germany.[3] Later that year, St. Jude Medical expanded into tissue heart valves with its acquisition of BioImplant.[3][12]

Products[edit]

St. Jude Medical produces MediGuide, a cardiac navigation and visualization technology that provides real-time fluoroscopic images.[13][14] The system also gives doctors the ability to locate devices that are implanted with MediGuide-enabled sensors.[13][14] MediGuide reduces the duration of a patients' radiation exposure during cardiovascular procedures.[13][15]

The company also manufactures the Assura line of implantable cardioverter-defibrillators (ICDs) and implanted cardiac resynchronization devices (CRT-Ds).[16][17] The ICDs and CRT-Ds use quadripolar lead technology, which utilizes four electrodes on a single lead to pace multiple locations on the left side of the heart.[18]

In 2013, the company began marketing the Ilumen Optis device, which is a diagnostic and assessment tool for patients with coronary artery disease.[19] The device uses fractional flow reserve for measuring intra-arterial pressure and optical coherence tomography technology, which allows doctors to visually examine inside a patient's arteries.[20]

Heart lead recall[edit]

On Nov. 28, 2011 St. Jude Medical recalled Riata and Riata ST leads due to device failure. The recall occurred because erosion of the insulation around the electrical conductor wires that connect the heart to the implantable cardioverter defibrillator.[21]

A probe was conducted by the Food and Drug Administration (FDA) at the manufacturing plant in Sylmar, California, which could result in a warning letter.[22]

Almost a year later in the third and fourth weeks of November 2012 the FDA found several problems in the Durata, which is the electrical wire that connects an implanted defibrillator to a patients heart. The FDA inspectors said that they found flaws in the testing process and oversight of the Durata. People have voiced their worries on the possible glitches in the Durata, and many of them are people who are very educated on the previous problems with the heart wire the Riata. One of these people is a heart specialist in Minnesota named Dr. Robert Hauser. He feels the people at St. Jude Medical have not given patients and doctors enough information, and early in 2012 he had written an article criticizing the Riata. But St. Jude Medical has stuck by their product, and claim the Durata will not be a problem like the Riata was because they used a different type of insulation.[23]

Employment and Financial Problems[edit]

In August 2012 St. Jude Medical eliminated 300 positions from the company. Then in November 2012 they proceeded to eliminate 500 more jobs from the company. These two job cuts combined equal 5% of the company's global work force. And though this originally looked to be a bad thing or a sign of weakness people have speculated and company representatives have said that it is very helpful to company financials. The job cut of 300 will potentially save $50 million to $60 million in cost savings for 2013 Rachel Ellingson, vice president said. And the company is supposed to announce how much the second round of job cuts, that cut 500 jobs, will save in January. This prediction has given investors a very positive outlook, and they are saying that this is the company's way of becoming more efficient in a tough economy.[24]

CEO Arrest[edit]

The CEO, Daniel J. Starks, was arrested in New Delhi, India in 2011 for violating local arms control laws by having a single live 45 caliber bullet in his luggage.[25]

External links[edit]

References[edit]

  1. ^ a b c "St. Jude Medical Reports Fourth Quarter and Full-Year 2013 Results". Securities and Exchange Commission. Retrieved 6 March 2014. 
  2. ^ a b "St. Jude Medical, Inc. 10-K". Securities and Exchange Commission. Retrieved 6 March 2014. 
  3. ^ a b c d e f g h i j k "St. Jude Medical, Inc.". International Directory of Company Histories. Retrieved 6 March 2014. 
  4. ^ a b c d e Terry Fiedler; Staff Writer (3 October 2002). "A perfectible heart ; St. Jude Medical's mechanical heart valve is still the market standard 25 years after a Minnesota woman received the first implant in surgery at the U of M.". Star Tribune (Mpls.-St. Paul). 
  5. ^ "Fortune 500: 445. St. Jude Medical". CNN Money. Retrieved 6 March 2014. 
  6. ^ "St. Jude Medical Inc". CNN Money. Retrieved 6 March 2014. 
  7. ^ "ST. JUDE MEDICAL ELECTS REES CHIEF, HENDRICKSON CHAIRMAN". The Wall Street Journal. 9 September 1981. 
  8. ^ "St. Jude Medical Wins Court Order for Supply Of Heart-Valve Parts". The Wall Street Journal. 12 October 1984. 
  9. ^ Richard Gibson Staff Reporter of The Wall Street Journal (14 January 1985). "St. Jude Medical, Shelves Nearly Bare, Tries to Attract a New Chief Executive". The Wall Street Journal. 
  10. ^ a b "St. Jude Medical Picks Lawrence Lehmkuhl As President and Chief". The Wall Street Journal. 12 February 1985. 
  11. ^ Richard Gibson (19 September 1985). "Heart Valve Companies Are Ready for Battle As St. Jude Medical Gets Back in the Market". The Wall Street Journal. 
  12. ^ "St. Jude Medical, Inc.". Hoovers. Retrieved 14 April 2014. 
  13. ^ a b c "St Jude Medical launches real-time cardiac navigation technology". Medical Device Network. Retrieved 20 March 2014. 
  14. ^ a b "CRT Implantation Using a New Sensor-Based Navigation System: Results from the First Human Use Study". American Heart Association. Retrieved 20 March 2014. 
  15. ^ "3D Cardiovascular Navigation System: Accuracy and Reduction in Radiation Exposure in Left Ventricular Lead Implant". Journal of Cardiovascular Electrophysiology. Retrieved 20 March 2014. 
  16. ^ "Company roundup". STAR TRIBUNE (Mpls.-St. Paul). 25 June 2013. 
  17. ^ "Tachycardia; St. Jude Medical Announces FDA Approval of Assura (TM) Implantable Defibrillators with Features That Reduce Inappropriate Shocks". Politics & Government Week. 24 May 2012. 
  18. ^ "Postoperative Performance of the Quartet Left Ventricular Heart Lead". Journal of Cardiovascular Electrophysiology. Retrieved 20 March 2014. 
  19. ^ "St. Jude Medical’s Ilumien Optis 3-D PCI Optimization System Approved in Europe". Cardiac Interventions Today. Retrieved 20 March 2014. 
  20. ^ "St. Jude’s ILUMIEN OPTIS PCI Optimization System with FFR, OCT Cleared in EU". Med Gadget. Retrieved 20 March 2014. 
  21. ^ "FDA Safety Communication: Premature Insulation Failure in Recalled Riata Implantable Cardioverter Defibrillator (ICD) Leads Manufactured by St. Jude Medical, Inc.". Food and Drug Administration. 2012-08-16. Retrieved October 17, 2012. 
  22. ^ Walker, Joseph (October 17, 2012). "St. Jude Reports Lower Earnings, FDA Probe of Facility". The Wall Street Journal Online. Retrieved October 17, 2012. 
  23. ^ Meier, B. (2012, November 26). A Name Blacked Out, a Reputation at Risk. New York Times, Business. Retrieved from http://www.nytimes.com/2012/11/27/ business/st-jude-medical-suffers
  24. ^ Walsh, J. (2012, November 2). St. Jude Medical job cuts may pay off. Star Tribune, Business. Retrieved from http://www.startribune.com/business/ 177048491.html?refer=y
  25. ^ http://www.indianexpress.com/news/american-arrested-with-live-cartridge-at-delhi-airport/763371/ American arrested with live cartridge at Delhi airport