Synthes
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Synthes Holding AG (formerly Synthes-Stratec) is a multinational
medical device A medical device is any device intended to be used for medical purposes. 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 assura ...
manufacturer based in
Solothurn Solothurn ( ; ; ; ; ) is a town, a municipality, and the capital of the canton of Solothurn in Switzerland. It is located in the north-west of Switzerland on the banks of the Aare and on the foot of the Weissenstein Jura mountains. The town is ...
,
Switzerland Switzerland, officially the Swiss Confederation, is a landlocked country located in west-central Europe. It is bordered by Italy to the south, France to the west, Germany to the north, and Austria and Liechtenstein to the east. Switzerland ...
and
West Chester, Pennsylvania West Chester is a borough (Pennsylvania), borough and the county seat of Chester County, Pennsylvania, United States. Located in the Delaware Valley, Philadelphia metropolitan area, the borough had a population of 18,671 at the 2020 census. West ...
, United States. It is the world's largest maker of implants to mend bone fractures, and also produces surgical
power tool A power tool is a tool that is actuator, actuated by an additional engine, power source and mechanism (engineering), mechanism other than the solely manual labour, manual labor used with hand tools. The most common types of power tools use electric ...
s and advanced
biomaterial A biomaterial is a substance that has been Biological engineering, engineered to interact with biological systems for a medical purpose – either a therapeutic (treat, augment, repair, or replace a tissue function of the body) or a Medical diag ...
s. In June 2012 Synthes was sold by its chairman, former
CEO A chief executive officer (CEO), also known as a chief executive or managing director, is the top-ranking corporate officer charged with the management of an organization, usually a company or a nonprofit organization. CEOs find roles in variou ...
and largest shareholder
Hansjörg Wyss Johann Georg "Hansjörg" Wyss ( ; born 19 September 1935) 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 medic ...
to
Johnson & Johnson Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a c ...
for $20.2 billion. The company is part of Johnson & Johnson MedTech business segment.


History

Synthes was originally established in 1960 as a
trademark A trademark (also written trade mark or trade-mark) is a form of intellectual property that consists of a word, phrase, symbol, design, or a combination that identifies a Good (economics and accounting), product or Service (economics), service f ...
of the Swiss non-profit institute
Arbeitsgemeinschaft für Osteosynthesefragen 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 ...
(, AO/ASIF), The Synthes trademark was applied to
internal fixation Internal fixation is an Surgery, operation in orthopedics that involves the surgical implementation of Implant (medicine), implants for the purpose of repairing a bone, a concept that dates to the mid-nineteenth century and was made applicable fo ...
implants produced under license by its industrial partners, Straumann Group and Mathys Medizinaltechnik. In 1975, the company Synthes (internal fixation implants) was spun off from AO/ASIF and Straumann who focused thereafter on tooth implants. In the same year, Synthes USA, a firm founded by
Harvard Harvard University is a private Ivy League research university in Cambridge, Massachusetts, United States. Founded in 1636 and named for its first benefactor, the Puritan clergyman John Harvard, it is the oldest institution of higher lear ...
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. 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 In marketing and consumer behaviour, brand loyalty describes a consumer's persistent positive feelings towards a familiar brand and their dedication to purchasing the brand's products and/or services repeatedly regardless of deficiencies, a ...
to Synthes products. In 1990 Straumann spun off its implant business into a separate privately owned company, Stratec Medical. Stratec partially listed its shares on the
SWX Swiss Exchange SIX Swiss Exchange (formerly SWX Swiss Exchange), based in Zürich, is Switzerland's principal stock exchange (the other being BX Swiss). SIX Swiss Exchange also trades other securities such as Swiss government bonds and derivatives such as sto ...
through an
initial public offering An initial public offering (IPO) or stock launch is a public offering in which shares of a company are sold to institutional investors and usually also to retail (individual) investors. An IPO is typically underwritten by one or more investm ...
six years later, while Synthes USA and Mathys remained in private hands. Three years later, however, Stratec and Synthes USA
merged Mergers and acquisitions (M&A) are business transactions in which the ownership of a company, business organization, or one of their operating units is transferred to or consolidated with another entity. They may happen through direct absorpt ...
to form a new
publicly traded company A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange ( ...
named Synthes-Stratec. After the merger Hansjörg Wyss became, and remained (until the sale to Johnson & Johnson) the majority
shareholder A shareholder (in the United States often referred to as stockholder) of corporate stock refers to an individual or legal entity (such as another corporation, a body politic, a trust or partnership) that is registered by the corporation as the ...
of the enlarged company. The third of the original AO/ASIF partner companies, Mathys, sold its osteosynthesis department to Synthes-Stratec in 2004, although the firm's
German German(s) may refer to: * Germany, the country of the Germans and German things **Germania (Roman era) * Germans, citizens of Germany, people of German ancestry, or native speakers of the German language ** For citizenship in Germany, see also Ge ...
division was
divested In finance and economics, divestment or divestiture is the reduction of some kind of asset for financial, ethical, or political objectives or sale of an existing business by a firm. A divestment is the opposite of an investment. Divestiture is a ...
to satisfy competition authorities. The company subsequently dropped the "-Stratec"
suffix In linguistics, a suffix is an affix which is placed after the stem of a word. Common examples are case endings, which indicate the grammatical case of nouns and adjectives, and verb endings, which form the conjugation of verbs. Suffixes can ca ...
to become simply Synthes. The company's shares were added to the benchmark
Swiss Market Index The Swiss Market Index (SMI) is Switzerland's blue-chip stock market index, which makes it the most followed in the country. It is made up of 20 of the largest and most liquid Swiss Performance Index (SPI) stocks. As a price index, the SMI i ...
for the first time in September 2004. In 2006 the company acquired the rights to the Synthes brand name and most of the related
intellectual property Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, co ...
, including
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...
s, from the AO/ASIF foundation for around CHF1 billion. 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. In November 2010, Synthes acquired USA based privately owned surgical tools maker ''The Anspach Effort, Inc''; the purchase price was not disclosed. On April 27, 2011, Synthes and
Johnson and Johnson Johnson & Johnson (J&J) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical, biotechnology, and Medical device, medical technologies corporation headquartered in New Brunswick, New Jersey, and publi ...
DePuy agreed to a
merger Mergers and acquisitions (M&A) are business transactions in which the ownership of a company, business organization, or one of their operating units is transferred to or consolidated with another entity. They may happen through direct absorpt ...
deal. The merger created the world's largest orthopedic corporation. On June 13, 2012
Johnson & Johnson Johnson & Johnson (J&J) is an American multinational pharmaceutical, biotechnology, and medical technologies corporation headquartered in New Brunswick, New Jersey, and publicly traded on the New York Stock Exchange. Its common stock is a c ...
announced the acquisition of Synthes for $19.7 billion. 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 Injury is physiology, physiological damage to the living tissue of any organism, whether Injury in humans, in humans, Injury in animals, in other animals, or Injury in plants, in plants. Injuries can be caused in many ways, including mechanic ...
,
spinal injuries A spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in its function. It is a destructive neurological and pathological state that causes major motor, sensory and autonomic dysfunctions. Symptoms of ...
and CMF ( craniomaxillofacial) trauma, as well as for
osteotomy An osteotomy is a surgical operation whereby a bone is cut to shorten or lengthen it or to change its alignment. It is sometimes performed to correct a hallux valgus, or to straighten a bone that has healed crookedly following a fracture. It i ...
in animals such as
horse The horse (''Equus ferus caballus'') is a domesticated, one-toed, hoofed mammal. It belongs to the taxonomic family Equidae and is one of two extant subspecies of ''Equus ferus''. The horse has evolved over the past 45 to 55 mi ...
s and
dog The dog (''Canis familiaris'' or ''Canis lupus familiaris'') is a domesticated descendant of the gray wolf. Also called the domestic dog, it was selectively bred from a population of wolves during the Late Pleistocene by hunter-gatherers. ...
s. Synthes' other business segments are the production of
surgical Surgery is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery ...
power tool A power tool is a tool that is actuator, actuated by an additional engine, power source and mechanism (engineering), mechanism other than the solely manual labour, manual labor used with hand tools. The most common types of power tools use electric ...
s and
biomaterial A biomaterial is a substance that has been Biological engineering, engineered to interact with biological systems for a medical purpose – either a therapeutic (treat, augment, repair, or replace a tissue function of the body) or a Medical diag ...
s 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. 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. 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. 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. 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. 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. In late 2011, all four executives received prison sentences ranging from five to nine months.


References


External links

* {{Philadelphia Corporations 1960 establishments in Switzerland Health care companies of Switzerland Manufacturing companies of Switzerland Johnson & Johnson subsidiaries 2012 mergers and acquisitions Swiss brands