St. Jude Medical

This article is about the medical device company. For the nonprofit hospital, see St. Jude Children's Research Hospital.
St. Jude Medical
Publicly traded
Traded as NYSE: STJ
S&P 500 Component
Industry Medical devices
Founded Saint Paul, Minnesota, 1976
Founder Manuel A. Villafana
Headquarters Little Canada, Minnesota
Area served
 Worldwide
Key people
 Michael T. Rousseau, 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
Revenue $5.6 billion (2014) Increase[1]
Total assets $10.207 billion (2014) Increase[1]
Total equity $4.2 billion (2014) Increase[1]
Number of employees
 18,000[2]
Website www.sjm.com

St. Jude Medical, Inc. (NYSE: STJ) is an American global medical device company headquartered in Little Canada, Minnesota, U.S., a suburb of Saint Paul. The company has more than 20 principal operations and manufacturing facilities worldwide with products sold in more than 100 countries.[3][4] 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.[4]

St. Jude Medical was founded in 1976 and went public in 1977,[4][5] and the company has been listed in the Fortune 500 every year since 2010.[6] The company is slated to be acquired by Abbott Laboratories at the end of 2016.[7][8]

Michael T. Rousseau serves as the company's president and chief executive officer.[9]

History

Early history

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.[4][5] 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.[5]

Company founder Manny Villafana took St. Jude Medical public in February 1977.[4] In October of that year, Dr. Nicoloff implanted the company's first artificial heart valve in a human patient.[5] St. Jude Medical's new heart valve was coated in pyrolytic carbon, which helped the valve prevent blood clotting.[4][5]

St. Jude Medical founding chief operating officer LaVerne Rees became chief executive officer in 1981.[10] Shortly after his appointment as St. Jude Medical CEO, Rees directed the company to begin development of its own carbon coating.[4] This decision led to a legal battle with CarboMedics, the sole supplier of carbon coating for the company's heart valves.[11] The St. Jude Medical board reassigned Rees in late 1984 after the legal dispute continued.[4][12]

In 1985, Lawrence Lehmkuhl replaced Rees as president and CEO of St. Jude Medical.[13] Lehmkuhl had previously served as a division president at American Hospital Supply Corporation.[13] Shortly after the appointment, St. Jude Medical settled its lawsuit with CarboMedics.[14] 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.[4]

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.[4] Later that year, St. Jude Medical expanded into tissue heart valves with its acquisition of BioImplant.[4][15]

1990s

The company established its International Division, located in Brussels, Belgium, in 1990. In April 1991, St. Jude Medical engaged in a joint venture with Hancock Jaffe Laboratories to create Heart Valve Company.[16][17] The joint venture was formed to design and market new tissue heart valves for the American market.[16] The first Heart Valve Company tissue heart valve was implanted in a human patient in 1994.[16]

In March 1993, Ronald Matricaria, a former president of Eli Lilly & Company's North American division, replaced Lehmkuhl as president and CEO of St. Jude Medical.[18] Lehmkuhl, who had presided over a ninefold increase in annual sales during his tenure as CEO, was named chairman of the St. Jude Medical board.[18][19]

Matricaria pushed for increasing diversification and expanded St. Jude Medical's acquisition hunt.[4] In June 1994, the company announced that it would acquire the Pacesetter, Inc., the heart pacemaker division of Siemens AG, for $500 million.[20] At the time of its acquisition by St. Jude Medical, Pacesetter was the second largest pacemaker manufacturer worldwide.[20]

In January 1996, St. Jude Medical further diversified its business when it acquired Minnetonka, Minnesota-based Daig Corporation for $425 million.[21] Daig Corporation manufactured cardiac catheters for diagnostic and therapeutic uses.[21] Also in January of that year, St. Jude Medical became the sole owner of Heart Valve Company when it purchased Hancock Jaffe Laboratories' 50% share in the joint venture.[21] St. Jude Medical acquired Biocor Industria, a Brazilian manufacturer of tissue heart valves, in September 1996.[22]

In 1997, St. Jude Medical acquired Ventritex, a Sunnyvale, California-based manufacturer of implantable cardioverter-defibrillators for $352 million.[23] At the time of its acquisition, Ventritex was the third-largest manufacturer of defibrillators.[23]

In February 1999, St. Jude Medical acquired Tyco International's Angio-Seal business.[24] Angio-Seal manufactured collagen-based plugs to close arterial holes made during arterial catheter procedures.[24] Matricaria stepped down as St. Jude Medical CEO in March 1999.[25] He was replaced by Terry Shepherd, who had served as president of St. Jude Medical's heart valve business since 1994.[25] Matricaria retained chairmanship of the St. Jude Medical board.[25]

2000s

In 2004, St. Jude Medical CEO Terry Shepherd retired.[26] The company's stock had increased 277% during his tenure as CEO.[26] St. Jude Medical COO Daniel Starks was appointed to replace Shepherd as the company's CEO.[26] Starks had previously served as chief executive officer of Daig Corporation from 1986-1996, when St. Jude Medical acquired the company.[26] Starks had been retained by St. Jude Medical and had served as company chief operating officer since 2001.[26]

In January 2005, St. Jude Medical acquired Saint Paul, Minnesota-based Endocardial Solutions for $272 million.[27] Endocardial Solutions manufactured diagnostic and therapeutic devices used to treat atrial fibrillation.[27] Later that year the company acquired Plano, Texas-based Advanced Neuromodulation Systems for $1.3 billion.[28] At the time of its acquisition, Advanced Neuromodulation Systems was the second-largest supplier of devices that use electrotherapy to treat chronic pain and nerve disorders.[28][29]

In 2008, St. Jude Medical acquired MediGuide, an Israeli company that developed technology that uses tiny sensors to locate medical devices inside of a patient's body and increase the amount of information available to a doctor during medical procedures.[30]

2010s

St. Jude Medical acquired AGA Medical for $1.3 billion in October 2010.[15] AGA Medical was a Plymouth, Minnesota-based company that manufactured products that treat heart defects, including plugs and patches that fix holes and other cardiac defects.[31][32] In 2010 the company also acquired LightLab Imaging, a company that developed optical coherence tomography technology that helps doctors treat heart disease.[33]

In 2010, St. Jude Medical invested in an option to acquire CardioMEMS Inc., a medical device company that developed a wireless sensing and communication technology to monitor pulmonary artery pressure (PAP) in heart failure patients. CardioMEMS Inc. was acquired by St. Jude Medical in May 2014.[34][35]

In August 2012, St. Jude Medical reorganized its business operations.[36] The company folded its four product divisions into two operating units: the implantable electronic systems division; and the cardiovascular and ablation technologies division.[36] The company also centralized other functions including the marketing, information technology and legal departments.[36] St. Jude Medical's reorganization coincided with layoffs of about 5% of the company's global workforce.[36]

In 2013, St. Jude Medical acquired Endosense, a Swiss company that developed a catheter that measures the force a doctor places on a patient's heart wall during a catheter ablation procedure.[37] St. Jude Medical paid $130 million for the company.[37]

In June 2013, St. Jude Medical entered into a series of agreements under which the company made a $40 million equity investment in Spinal Modulation, Inc.[38] In May 2015, the company completed the acquisition of Spinal Modulation, developer of the Axium Neurostimulator System.[39]

St. Jude Medical acquired Nanostim Inc., a Sunnyvale, California-based privately owned developer of miniaturized, leadless pacemakers, for $123.5 million in October 2013.[40] The acquisition followed the approval of Nanostim's leadless pacemaker by the European Union.[40] St. Jude Medical had secured the exclusive right to acquire Nanostim with a May 2011 investment in the start-up.[41]

St. Jude Medical continued the restructuring it started in 2014 with its consolidation of the company's two operating units—the implantable electronic systems and the cardiovascular and ablation technologies units—into single research and development division.[42] The company also consolidated its worldwide manufacturing and supply chain operations into a second division.[42]

In July 2015, the company announced its intention to acquire heart-device manufacturer Thoratec Corporation for $3.4 billion.[43] The acquisition was completed in October 2015.[44]

In September 2015, St. Jude Medical announced that Daniel Starks would retire as chairman, president, and chief executive officer. On January 1, 2016, Michael T. Rousseau succeeded Starks as president, CEO and a member of the St. Jude Medical Board of Directors. Starks would remain executive chairman of the board of directors.[9]

In late April 2016, Abbott Laboratories announced it would acquire St. Jude Medical for $25 billion ($46.75 in cash & 0.8708 shares of Abbott common stock, equating to an approximate value of $85 per share).[45][46]

Acquisition history

The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list):

St. Jude Medical


















St. Jude Medical
(Est 1976)

Pacesetter, Inc.
(Acq 1994)

Daig Corporation
(Acq 1996)

Heart Valve Company
(Acq remaining 50% from joint venture with Hancock Jaffe Laboratories' 1996)

Biocor Industria
(Acq 1996)

Ventritex
(Acq 1997)

Tyco International
(Angio-Seal div, Acq 1999)

Endocardial Solutions
(Acq 2005)

Advanced Neuromodulation Systems
(Acq 2005)

MediGuide
(Acq 2008)

AGA Medical
(Acq 2010)

LightLab Imaging
(Acq 2010)

CardioMEMS Inc.
(Acq 2014)

Endosense
(Acq 2013)

Spinal Modulation
(Acq 2015)

Nanostim Inc
(Acq 2013)

Thoratec Corporation
(Acq 2015)

Apica Cardiovascular Limited
(Acq 2014)

Levitronix
(Acq 2011)

Getinge Group
(Heart pump technology div, Acq 2014)

Thermo Cardiosystems
(Acq 2010)








Operations

St. Jude Medical manufactures implantable cardioverter-defibrillators (ICD); pacemakers; electrophysiology catheters; vascular closure products; cardiac mapping and visualization systems; optical coherence tomography (OCT) imaging systems; structural heart repair products; and neurostimulation devices.[3] The company's operations are divided into two divisions: research and development; and manufacturing and supply chain.[47]

St. Jude Medical also operates six technology centers located in Brussels, Belgium, Beijing, China, Tokyo, Japan, Austin, Texas, St. Paul, Minnesota and Sylmar, California.[48][49][50] These centers offer training to physicians and allow them to simulate patient procedures using St. Jude Medical devices and technologies.[48][49]

Products

The company also manufactures the Assura line of implantable cardioverter-defibrillators (ICDs) and implanted cardiac resynchronization devices (CRT-Ds).[51][52] 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.[53]

In 2013, the company began marketing the Ilumen Optis device, which is a diagnostic and assessment tool for patients with coronary artery disease.[54] 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.[55]

Technology

MediGuide

St. Jude Medical produces MediGuide, a cardiac navigation and visualization technology that provides real-time fluoroscopic images.[56][57] The system also gives doctors the ability to locate devices that are implanted with MediGuide-enabled sensors.[56][57] MediGuide reduces the duration of a patients' radiation exposure during cardiovascular procedures.[56][58]

Nanostim

In October 2013, the company acquired and began developing Nanostim leadless pacemakers. Nanostim technology consists of a miniaturized pacemaker implanted by a percutaneous, catheter-based procedure and placed into the heart. They are designed without the requirement for a lead, the thin wires inserted through a vein which connect the generator to the heart, or surgical pocket.[59]

CardioMEMS

In June 2014, St. Jude Medical acquired and began developing CardioMEMS HF System, a wireless pulmonary artery pressure (PAP) monitoring technology. The wireless monitoring technology is used to assess cardiac performance via measurement of PAP and can be placed into the pulmonary artery. The CardioMEMS PAP monitoring system is supported by strong clinical evidence from the CHAMPION clinical trial,[60] showing that it "was associated with a 37% reduction in the rate of hospitalization in patients with heart failure."[61]

Controversies

In December 2010, St. Jude Medical voluntarily stopped selling its Riata and Riata ST line of defibrillator leads over concerns that the leads were susceptible to insulation abrasion.[62][63] The Food and Drug Administration issued a recall of the leads in November 2011.[63][64] In May 2013, Population Health Research Institute (PHRI), an academic health science research institute, conducted an independent analysis of data received from ongoing prospective registries that monitor the performance of the Durata and Riata ST ICD leads.[65] The results of the analysis found that the insulated leads had a 99.8 percent rate of freedom from all-cause insulation abrasion at 5 years.[65]

In January 2013, the Food and Drug Administration sent St. Jude Medical a warning letter detailing concerns regarding processes at the company's Sylmar, California facility.[66] The letter was sent following inspections of the plant in September and October 2012.[66] The letter did not raise any safety concerns about St. Jude Medical products.[66]

That same month the company sent the Food and Drug Administration a 34-page letter detailing the company's efforts to correct problems found during the October inspection.[67]

References

  1. 1 2 3 "St. Jude Medical Reports Fourth Quarter and Full-Year 2014 Results". BusinessWire. Retrieved December 30, 2015.
  2. ↑ "Lisa Andrade Discusses St. Jude Medical's Medical Device Manufacturer of the Year Award". St. Jude Medical. Retrieved December 30, 2015.
  3. 1 2 "St. Jude Medical, Inc. 10-K". Securities and Exchange Commission. Retrieved 6 March 2014.
  4. 1 2 3 4 5 6 7 8 9 10 11 12 "St. Jude Medical, Inc.". International Directory of Company Histories. Retrieved 6 March 2014.
  5. 1 2 3 4 5 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).
  6. ↑ "Fortune 500: 445. St. Jude Medical". CNN Money. Retrieved 6 March 2014.
  7. ↑ http://www.bloomberg.com/news/articles/2016-04-28/abbott-agrees-to-buy-st-jude-medical-for-25-billion
  8. ↑ http://www.bloomberg.com/news/videos/2016-04-28/abbott-st-jude-combination-why-it-makes-sense
  9. 1 2 "St. Jude Medical Announces Leadership Transition Plan". BusinessWire. September 9, 2015. Retrieved December 30, 2015.
  10. ↑ "ST. JUDE MEDICAL ELECTS REES CHIEF, HENDRICKSON CHAIRMAN". The Wall Street Journal. 9 September 1981.
  11. ↑ "St. Jude Medical Wins Court Order for Supply Of Heart-Valve Parts". The Wall Street Journal. 12 October 1984.
  12. ↑ 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.
  13. 1 2 "St. Jude Medical Picks Lawrence Lehmkuhl As President and Chief". The Wall Street Journal. 12 February 1985.
  14. ↑ 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.
  15. 1 2 "St. Jude Medical, Inc.". Hoovers. Retrieved 14 April 2014.
  16. 1 2 3 "St. Jude bioprosthetic valve implanted.". Reuters News. 30 March 1994.
  17. ↑ Edward A. Wyatt (31 August 1992). "The Mugging of St. Jude --- Why the Street's Wrong in Roughing Up the Stock". Barron's.
  18. 1 2 MILT FREUDENHEIM (March 23, 1993). "COMPANY NEWS; Lilly Executive Named Chief of St. Jude Medical". New York Times.
  19. ↑ Steve Gross; Staff Writer (18 March 1993). "Lehmkuhl named St. Jude chairman, Matricaria new president and CEO // New chief executive is a former head of Eli Lilly pacemaker subsidiary in Roseville". Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul.
  20. 1 2 Steve Alexander; Staff Writer (29 June 1994). "The wait is over: St. Jude announces big acquisition // Fridley firm plans to buy pacemaker operations of Siemens AG for $500 million cash". Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul.
  21. 1 2 3 "Hancock Jaffe Sells Heart Valve Stake". Los Angeles Times. January 7, 1996.
  22. ↑ "St. Jude Medical Acquires Assets". The Wall Street Journal. 24 September 1996.
  23. 1 2 Terry Fiedler; Staff Writer (1 April 1997). "St. Jude Medical drops its acquisition price for California-based Ventritex // Stock deal worth $352 million; acquiring defibrillator firm a good fit, giving St. Jude a presence in burgeoning market". Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul.
  24. 1 2 Terry Fiedler; Staff Writer (6 February 1999). "St. Jude buys vascular-seal company // $167 million deal makes it leader in fast-growing market". Star-Tribune Newspaper of the Twin Cities Mpls.-St. Paul.
  25. 1 2 3 Thomas M. Burton Staff Reporter of The Wall Street Journal (3 March 1999). "St. Jude Medical's CEO to Step Down In the Wake of Disappointing Results". The Wall Street Journal.
  26. 1 2 3 4 5 Janet Moore; Staff Writer (11 December 2003). "A STEADY PULSE ; St. Jude Medical's CEO is retiring, but all bets are on a smooth transition". Star-Tribune.
  27. 1 2 Janet Moore; Staff Writer (14 January 2005). "St. Jude completes Endocardial acquisition". Star-Tribune.
  28. 1 2 Barnaby J. Feder (13 January 2006). "With the Spotlight on a Rival, St. Jude Medical Shines". The New York Times.
  29. ↑ "U.S. heart-device maker to acquire smaller rival". The New York Times. 18 October 2005.
  30. ↑ Jon Kamp (23 December 2008). "Corporate News: St. Jude Is Set to Pay $533 Million For Two Medical-Tech Companies". The Wall Street Journal.
  31. ↑ CHEN MAY YEE; STAFF WRITER (19 October 2010). "ST. JUDE BUYS AGA MEDICAL // $1.1 billion deal is expected to give St. Jude a lead in treating structural heart disease.". STAR TRIBUNE (Mpls.-St. Paul).
  32. ↑ Jon Kamp (19 October 2010). "St. Jude in Deal for AGA Medical". The Wall Street Journal Online.
  33. ↑ JANET MOORE; STAFF WRITER (20 May 2010). "St. Jude to spend $90 million to buy imaging company". STAR TRIBUNE (Mpls.-St. Paul).
  34. ↑ David Morgan (8 December 2011). "FDA panel votes against CardioMEMS device". Reuters. Retrieved 25 September 2014.
  35. ↑ "St. Jude Medical Completes Acquisition of CardioMEMS". 2 June 2014. Retrieved 25 September 2014.
  36. 1 2 3 4 James Walsh (31 August 2012). "St. Jude lays off 300, reorganizes // Analysts saw a connection to what St. Jude will have to pay in a new medical device tax. Officials said the goals are broader.". STAR TRIBUNE (Mpls.-St. Paul).
  37. 1 2 PATRICK KENNEDY (20 August 2013). "St. Jude buys Swiss med tech company // St. Jude will pay $170 million for Endosense and could pay more if performance targets are met.". STAR TRIBUNE (Mpls.-St. Paul).
  38. ↑ Tess Stynes (April 20, 2015). "St. Jude Exercises Option to Acquire Spinal Modulation". Wall Street Journal. Retrieved December 30, 2015.
  39. ↑ "St. Jude Medical Completes Acquisition of Spinal Modulation". HospiMedica International. May 17, 2015. Retrieved December 30, 2015.
  40. 1 2 Cortez, Michelle (14 October 2013). "St. Jude Buys Nanostim as Pacemaker Gets EU Approval". Bloomberg News. Retrieved 17 May 2014.
  41. ↑ Katharine Grayson. "St. Jude backs lead-less pacemaker startup Nanostim". Minneapolis/St. Paul Business Journal. Retrieved 17 May 2014.
  42. 1 2 James Walsh. "St. Jude reorganizes its leadership". Star Tribune. Retrieved 17 May 2014.
  43. ↑ Harrison, Crayton (22 July 2015). "St. Jude to Acquire Implant Maker Thoratec for $3.4 Billion". Bloomberg.
  44. ↑ "St. Jude Medical Completes Acquisition of Thoratec". Business Wire. October 8, 2015.
  45. ↑ http://www.bloomberg.com/news/articles/2016-04-28/abbott-agrees-to-buy-st-jude-medical-for-25-billion
  46. ↑ http://www.bloomberg.com/news/videos/2016-04-28/abbott-st-jude-combination-why-it-makes-sense
  47. ↑ James Walsh. "St. Jude reorganizes its leadership". Star Tribune. Retrieved 28 April 2014.
  48. 1 2 "St. Jude Medical Expands Into Beijing, China". Asian Scientist. Retrieved 28 April 2014.
  49. 1 2 "St. Jude Medical advances China strategy, opens latest technology center". Med City News. Retrieved 28 April 2014.
  50. ↑ "Advanced Technology Centers". St. Jude Medical. Retrieved 28 April 2014.
  51. ↑ "Company roundup". STAR TRIBUNE (Mpls.-St. Paul). 25 June 2013.
  52. ↑ "Tachycardia; St. Jude Medical Announces FDA Approval of Assura (TM) Implantable Defibrillators with Features That Reduce Inappropriate Shocks". Politics & Government Week. 24 May 2012.
  53. ↑ "Postoperative Performance of the Quartet Left Ventricular Heart Lead". Journal of Cardiovascular Electrophysiology. Retrieved 20 March 2014.
  54. ↑ "St. Jude Medical's Ilumien Optis 3-D PCI Optimization System Approved in Europe". Cardiac Interventions Today. Retrieved 20 March 2014.
  55. ↑ "St. Jude's ILUMIEN OPTIS PCI Optimization System with FFR, OCT Cleared in EU". Med Gadget. Retrieved 20 March 2014.
  56. 1 2 3 "St Jude Medical launches real-time cardiac navigation technology". Medical Device Network. Retrieved 20 March 2014.
  57. 1 2 "CRT Implantation Using a New Sensor-Based Navigation System: Results from the First Human Use Study" (PDF). American Heart Association. Retrieved 20 March 2014.
  58. ↑ "3D Cardiovascular Navigation System: Accuracy and Reduction in Radiation Exposure in Left Ventricular Lead Implant". Journal of Cardiovascular Electrophysiology. Retrieved 20 March 2014.
  59. ↑ Larry Husten (13 May 2013). "Novel Leadless Pacemaker Makes Debut At HRS 2013". Forbes. Retrieved 25 September 2014.
  60. ↑ Abraham WT, Adamson PB, Bourge RC, et al. (19 February 2011). "Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial". The Lancet. Retrieved 25 September 2014.
  61. ↑ Marshall, Mallika (22 September 2014). "New Device Helps Heart Failure Patients Stay Out Of The Hospital". Boston, Massachusetts: WBZ-TV.
  62. ↑ Jon Kamp (17 December 2010). "St. Jude Ends Group of Defibrillator Cables". The Wall Street Journal Online.
  63. 1 2 James Walsh (16 December 2011). "FDA recalls St. Jude's Riata defibrillator lead over risks // The company took the Riata defibrillator lead off the market last year.". Star Tribune (Mpls.-St. Paul).
  64. ↑ "St. Jude Riata Defective Devices Lead to Major Lawsuit; Evidence Shows St. Jude Knew of Problems Years Before". Torklaw. Retrieved 12 November 2012.
  65. 1 2 Steve Stiles. "Few Failures Show Up in Durata, Riata ST Optim Defibrillator-Lead Analysis". Medscape. Retrieved 2 June 2014.
  66. 1 2 3 James Walsh (15 January 2013). "St. Jude receives warning letter // The FDA letter concerns manufacturing processes at a company plant in Sylmar, Calif, where St. Jude makes heart device leads.". Star Tribune (Mpls.-St. Paul).
  67. ↑ James Walsh (10 January 2013). "St. Jude outlines fixes at Calif. plant // The med-tech firm moved to head off further action by the FDA over concerns regarding the plant that makes heart defibrillator leads.". Star Tribune (Mpls.-St. Paul).
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