Synthes

Last updated
Synthes Holding AG
FormerlySynthes-Stratec
Company type Subsidiary
SIX: SYST
Industry Health care
Founded1999;25 years ago (1999)
Headquarters Solothurn, Switzerland (corporate), West Chester, Pennsylvania, United States (operational)
Key people
 Michel Orsinger (president and CEO)
Products Physical trauma, spine, craniofacial, mandible and chest implants, medical power tools, biomaterials
Revenue US $3.687 billion (2010) [1]
US $1.283 billion (2010) [1]
US $907.7 million (2010) [1]
Total assets US $7.924 billion (end 2010) [1]
Total equity US $6.739 billion (end 2010) [1]
Number of employees
11,430 (end 2010) [1]
Parent Johnson & Johnson
Website synthes.com

Synthes Holding AG (formerly Synthes-Stratec) is a multinational medical device manufacturer based in Solothurn, Switzerland and West Chester, Pennsylvania, United States. It is the world's largest maker of implants to mend bone fractures, [2] and also produces surgical power tools and advanced biomaterials.

Contents

In June 2012 Synthes was sold by its chairman, former CEO and largest shareholder Hansjörg Wyss to Johnson & Johnson for $20.2 billion. [3] The company is part of Johnson & Johnson MedTech business segment. [4]

History

Synthes was originally established in 1960 as a trademark of the Swiss non-profit institute Arbeitsgemeinschaft für Osteosynthesefragen (English: Association for the Study of Internal Fixation, AO/ASIF), [5]

The Synthes trademark was applied to internal fixation implants produced under license by its industrial partners, Straumann Group and Mathys Medizinaltechnik. [6] In 1975, the company Synthes (internal fixation implants) was spun off from AO/ASIF and Straumann who focused thereafter on tooth implants. [7] In the same year, Synthes USA, a firm founded by Harvard graduate Hansjörg Wyss, became the third company to form an alliance with AO/ASIF. Throughout the decade, Straumann and Mathys expanded their coverage around the rest of the world. [8] Because of its affiliation with AO/ASIF, which is in involved in mandatory training for many European orthopedic surgeons, healthcare practitioners are more likely to have brand loyalty to Synthes products. [9]

In 1990 Straumann spun off its implant business into a separate privately owned company, Stratec Medical. [10] Stratec partially listed its shares on the SWX Swiss Exchange through an initial public offering six years later, while Synthes USA and Mathys remained in private hands. [11]

Three years later, however, Stratec and Synthes USA merged to form a new publicly traded company named Synthes-Stratec. After the merger Hansjörg Wyss became, and remained (until the sale to Johnson & Johnson) the majority shareholder of the enlarged company. [12]

The third of the original AO/ASIF partner companies, Mathys, sold its osteosynthesis department to Synthes-Stratec in 2004, [13] although the firm's German division was divested to satisfy competition authorities. [14] The company subsequently dropped the "-Stratec" suffix to become simply Synthes. The company's shares were added to the benchmark Swiss Market Index for the first time in September 2004. [15]

In 2006 the company acquired the rights to the Synthes brand name and most of the related intellectual property, including patents, from the AO/ASIF foundation for around CHF1 billion. [16] AO also acquired a stake in Synthes. The two organisations continue to collaborate on relevant issues.

In October 2010, Synthes and its subsidiary Norian both pleaded guilty to crimes relating to illegally implanting bone cement without FDA approval. Norian will admit to a felony charge of conspiracy to impede FDA functions and pay a $23 million fine. Synthes will then divest Norian. [17]

In November 2010, Synthes acquired USA based privately owned surgical tools maker The Anspach Effort, Inc; the purchase price was not disclosed. [18]

On April 27, 2011, Synthes and Johnson and Johnson DePuy agreed to a merger deal. The merger created the world's largest orthopedic corporation. [19]

On June 13, 2012 Johnson & Johnson announced the acquisition of Synthes for $19.7 billion. [20] The merger led to jobs losses for some subsidiary groups. In Italy, the headquarters were moved from Milan to Rome.

Products

The company's product offering spans six divisions, of which four produce implants and related instruments for the treatment of physical trauma, spinal injuries and CMF (craniomaxillofacial) trauma, as well as for osteotomy in animals such as horses and dogs. Synthes' other business segments are the production of surgical power tools and biomaterials used to fill bone defects.

Norian XR scandal

In 2009 the U.S. attorney in Philadelphia accused the company of illegally promoting a bone void filler for unapproved uses, running unauthorized clinical trials, and failing to properly report deaths and adverse events related to the product. [21] Between 2002 and 2004, Synthes attempted to promote new uses for a product called Norian XR, a calcium phosphate bone void filler mixed with barium sulfate. The Food and Drug Administration explicitly told Synthes not to promote Norian for certain spine surgeries, but the company pushed forward anyway. At least five patients who had Norian injected into their spines died on the operating-room table. [22]

In 2009 Synthes announced a settlement with the state of New Jersey over concerns that clinical investigators did not disclose their financial interests. In November 2009 Synthes pleaded guilty to allegations of shipping “adulterated and misbranded” products as part of unlawful clinical trials. [23]

The indictment charges Synthes Inc. with a total of 52 felony counts: conspiracy to impair and impede the lawful functions of the FDA and to commit crimes against the US; 7 counts of making false statements in connection with an FDA inspection; and 44 counts of shipping adulterated and misbranded Norian XR in interstate commerce with intent to defraud.

The parent company, Synthes, was charged with 44 misdemeanor counts of shipping adulterated and misbranded Norian XR in interstate commerce, and the four executives, Michael D. Huggins, Thomas B. Higgins, Richard E. Bohner and John J. Walsh, were each charged with one strict liability misdemeanor offense. Synthes Inc. acquired N Spine Inc. in 2007. [22]

From May 2002 until fall 2004 Norian conspired with others, including Synthes and the four named executives, to conduct unauthorized clinical trials of Synthes's medical devices, Norian XR and Norian SRS, in surgeries to treat vertebral compression fractures of the spine (VCFs), a painful condition commonly suffered by elderly individuals. [22]

These surgeries were allegedly performed despite a warning on the FDA-cleared label for Norian XR against this use, and in the face of serious medical concerns about the safety of the devices when used in the spine.

According to the indictment, before the marketing program began, pilot studies showed the company that the bone cement reacted chemically with human blood in a test tube to cause blood clots. The research also showed, in a pig, that leakage of small amounts of Norian XR from the spine into the blood caused clots, which become lodged in the lungs. Notwithstanding this knowledge, the company allegedly proceeded to market the product for VCFs without putting it through FDA-required testing. The company, it is alleged, did not stop marketing the product until after a third patient had died on the operating table. [22] [24]

In late 2011, all four executives received prison sentences ranging from five to nine months. [22] [25]

Related Research Articles

Stryker Corporation is an American multinational medical technologies corporation based in Kalamazoo, Michigan. Stryker's products include implants used in joint replacement and trauma surgeries; surgical equipment and surgical navigation systems; endoscopic and communications systems; patient handling and emergency medical equipment; neurosurgical, neurovascular and spinal devices; as well as other medical device products used in a variety of medical specialties.

Ethicon, Inc. is a subsidiary of Johnson & Johnson. The company is part of the Johnson & Johnson MedTech business segment. It was incorporated as a separate company under the Johnson & Johnson umbrella in 1949 to expand and diversify the Johnson & Johnson product line.

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DePuy Synthes is a franchise of orthopaedic and neurosurgery companies. Acquired by Johnson & Johnson in 1998, its companies form part of the Johnson & Johnson MedTech business segment. DePuy develops and markets products under the Codman, DePuy Mitek, DePuy Orthopaedics and DePuy Spine brands.

Invacare Corporation is an American manufacturer and distributor of non-acute medical equipment including wheelchairs, mobility scooters, walkers, pressure care and positioning, as well as respiratory products. Headquartered in Elyria, Ohio, the company currently distributes its product to more than 80 countries around the world. In February 2023, Invacare stated that it had filed for Chapter 11 bankruptcy.

<span class="mw-page-title-main">Nobel Biocare</span> Manufacturer of dental implants

Nobel Biocare is a Swiss company originally founded in Sweden for manufacturing dental implants. It is now headquartered in Kloten, Switzerland near the Zürich Airport. Nobel Biocare in its current form was founded in 2002. It originates from a partnership formed in 1978 between Swedish medical researcher Professor Per-Ingvar Brånemark and Bofors, a Swedish company, to industrialize Brånemark's discovery of osseointegration. Beside dental implants, it also presently develops and commercializes CAD/CAM-based prosthetics equipments to scan teeth and to fabricate individualized dental prosthesis using digital technologies in place of silicone molding.

<span class="mw-page-title-main">AO Foundation</span> Medical organisation based in Switzerland

The AO Foundation is a nonprofit organization dedicated to improving the care of patients with musculoskeletal injuries or pathologies and their sequelae through research, development, and education of surgeons and operating room personnel. The AO Foundation is credited with revolutionizing operative fracture treatment and pioneering the development of bone implants and instruments.

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Straumann Group is a Swiss company based in Basel (Switzerland) manufacturing dental implants and specialized in related technologies. The group researches, develops, manufactures and supplies dental implants, instruments, biomaterials, CADCAM prosthetics, digital equipment, software, and clear aligners for applications in replacement, restorative, orthodontic and preventative dentistry.

Mentor Worldwide LLC is an American company that supplies surgical aesthetics products to plastic surgeons. The company is based in Santa Barbara, California and is part of Johnson & Johnson MedTech business segment. It produces one of two silicone gel breast implants. Titled MemoryGel, the product was approved by the U.S. Food and Drug Administration (FDA) on November 17, 2006. The other FDA-approved products are developed by competitors Allergan and Sientra. Mentor also produces a range of lipoplasty equipment for liposuction procedures as well as a Niacin-based skincare product line called NIA 24.

<span class="mw-page-title-main">Hansjörg Wyss</span> Swiss businessman and Democratic megadonor

Johann Georg "Hansjörg" Wyss is a Swiss billionaire businessman and donor to politically liberal and environmental causes in the United States. He is the founder and former president and chairman of Synthes, a medical device manufacturer. His Wyss Foundation has more than $2 billion in assets.

Maurice Edmond Müller was a Swiss orthopedic surgeon who was instrumental in the development of internal fixation techniques to treat bone fractures and who also significantly advanced the development of the hip prostheses. For his work in these areas he has been honored with numerous awards. On 24 August 2002, the International Society of Orthopaedic Surgery and Traumatology (SICOT) named him the "Orthopedic Surgeon of the Century" at a congress in San Diego.

Mathys Ltd Bettlach, is a Swiss family business with headquarters in Bettlach, Switzerland. The company develops, produces and distributes implants for artificial joint replacement in the areas of hip, knee and shoulder as well as biomaterials for surgical treatment of bone defects With an innovative implant for ACL healing, the family company also gained ground in the area of sport orthopaedics at the beginning of 2013.

Scott Spann is an American orthopaedic surgeon, medical device inventor, former world-class swimmer and recovered quadriplegic.

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Globus Medical, Inc. is a publicly traded medical device company headquartered in Audubon, Pennsylvania, United States. Globus is focused on the design, development, and commercialization of products that enable surgeons to promote healing in patients with musculoskeletal disorders.

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An orthopedic plate is a form of internal fixation used in orthopaedic surgery to hold fractures in place to allow bone healing and to reduce the possibility of nonunion. Most modern plates include bone screws to help the orthopedic plate stay in place.

The Wyss Institute for Biologically Inspired Engineering is a cross-disciplinary research institute at Harvard University focused on bridging the gap between academia and industry by drawing inspiration from nature's design principles to solve challenges in health care and the environment. It is focused on the field of biologically inspired engineering to be distinct from bioengineering and biomedical engineering. The institute also has a focus on applications, intellectual property generation, and commercialization.

References

  1. 1 2 3 4 5 6 "Annual Report 2010". Morningstar.com. Retrieved 9 May 2019.[ permanent dead link ]
  2. ↑ Lundgren, Kari; Haigh, Adam (21 February 2008). "BAE Systems, BP, Reed Elsevier: U.K., Irish Equity Preview". Bloomberg. Archived from the original on 16 February 2015. Retrieved 2008-06-10.
  3. ↑ "Forbes Profile: Hansjoerg Wyss". Forbes . n.d. Retrieved 9 May 2019.
  4. ↑ "Johnson & Johnson consolidates medtech brands under single banner". FIERCE Biotech. Sep 10, 2024.
  5. ↑ T. Schlich (2002) Surgery, Science and Industry. A Revolution in Fracture Care, 1950s-1990s (Houndsmills, Basingstoke: Palgrave)
  6. ↑ "Company history: 1958-1960". Synthes. Archived from the original on 21 August 2008. Retrieved 2008-06-17.
  7. ↑ "MEDICAL TECHNOLOGY – FROM CRAFTS TO HIGH-TECH". Swiss Medtech. Retrieved 2021-10-12.
  8. ↑ "Company history: 1970-1984". Synthes. Archived from the original on 21 August 2008. Retrieved 2008-06-17.
  9. ↑ SAGE Sourcebook of Modern Biomedical Devices: Business Environments in a Global Market. SAGE. 2007. p. 397. ISBN   978-1-4129-5054-1.
  10. ↑ Cohen, M.L. (2006). "Company history information about Straumann Holding AG". International Directory of Company Histories. The Gale Group. Archived from the original on 12 October 2007. Retrieved 2008-08-11.
  11. ↑ "Company history: 1990-1996". Synthes. Archived from the original on 21 August 2008. Retrieved 2008-08-11.
  12. ↑ Egenter, Sven (28 February 2008). "Synthes 2007 Net Profit Up 20 Pct, Beats Forecasts". Reuters . Archived from the original on July 21, 2012. Retrieved 2008-08-11.
  13. ↑ "Synthes-Stratec and Mathys join forces". SwissInfo.ch . 13 August 2003. Retrieved 2019-05-09.
  14. ↑ Bulkeley, Andrew (30 March 2004). "Germany blocks Synthes' buy". The Deal . Retrieved 2008-08-11.
  15. ↑ "Synthes neu im SMI vertreten". Neue Zürcher Zeitung (in German). 30 September 2004. Retrieved 2008-06-17.
  16. ↑ "Synthes comes of age after severing patent ties". SwissInfo.ch . 28 March 2006. Retrieved 2019-05-09.
  17. ↑ Dale, Maryclaire (2010-10-04). "Pa. firm to pay $23M for illegal bone cement tests". Yahoo News/Associated Press. Retrieved 2010-10-05.
  18. ↑ "Synthes acquires U.S. surgical tools maker Anspach". Reuters. 2010-11-08. Archived from the original on November 9, 2010. Retrieved 8 November 2010.
  19. ↑ http://www.synthes.com/html/News-Details.8013.0.html?&tx_synthesnewsbyxml_pi1[showUid]=65
  20. ↑ "Johnson & Johnson $ 19.7 billion acquisition of Synthes transactions to increase corporate profits". June 13, 2012. Archived from the original on January 24, 2013.
  21. ↑ Criminal Indictment
  22. 1 2 3 4 5 Kimes, Mina (September 18, 2012). "Bad to the bone: A medical horror story". Fortune .
  23. ↑ "Looking for a Band-Aid". The Economist. 2011-04-20.
  24. ↑ "Synthes executives indicted". 17 June 2009.
  25. ↑ Loftus, Peter (December 14, 2011). "Fourth Ex-Synthes Officer Sentenced". The Wall Street Journal. Dow Jones & Company. Retrieved March 18, 2012.
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