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SynthesHolding 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.

Synthes was originally established in 1960 as a trademark of the Swiss non-profit institute Arbeitsgemeinschaft fr Osteosynthesefragen (English: Association for the Study of Internal Fixation, AO/ASIF),[4]

The Synthes trademark was applied to internal fixation implants produced under license by its industrial partners, Straumann Group and Mathys Medizinaltechnik.[5] In 1975, the company Synthes (internal fixation implants) was spun off from AO/ASIF and Straumann who focused thereafter on tooth implants.[6] In the same year, Synthes USA, a firm founded by Harvard graduate Hansjrg 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.[7] 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.[8]

In 1990 Straumann spun off its implant business into a separate privately owned company, Stratec Medical.[9] 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.[10]

Three years later, however, Stratec and Synthes USA merged to form a new publicly traded company named Synthes-Stratec. After the merger Hansjrg Wyss became, and remained (until the sale to Johnson & Johnson) the majority shareholder of the enlarged company.[11]

The third of the original AO/ASIF partner companies, Mathys, sold its osteosynthesis department to Synthes-Stratec in 2004,[12] although the firm's German division was divested to satisfy competition authorities.[13] 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.[14]

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.[15] 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.[16]

On June 13, 2012 Johnson & Johnson announced the acquisition of Synthes for $19.7 billion.[19]The merger led to jobs losses for some subsidiary groups. In Italy, the headquarters were moved from Milan to Rome.

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.

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.[20] 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.[21]

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.[21]

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.[21]

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.[21][23]

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We thank the staff at the USC Center for Advanced Research Computing, and the Google Cloud Platform for Higher Education and Research for providing computational resources. The study was funded by National Institute on Drug Abuse grants R01DA041435 and R01DA045020 (to V.K. and A.M.), National Institute of Mental Health Grant R01MH112205 and Psychoactive Drug Screening Program (to B.L.R.) and the Michael Hooker Distinguished Professorship (to B.L.R.). B.H. was supported by NIGMS T32-GM118289.

A.A.S. and A.V.S. developed V-SYNTHES algorithms, performed calculations and wrote the first draft of the manuscript. B.H. and N.A.P. performed calculations and compound selection for ROCK1. Y.L., M.K.J., J.P. and X.-P.H. performed functional and selectivity assays. C.I.-T., N.K.T., F.T., N.Z. and S.P.N. performed binding assays. N.P. performed full VLS on Google Cloud. O.S., D.S.R. and Y.S.M. developed the REAL Space library and performed compound synthesis. B.L.R. supervised the functional and selectivity assays. A.M. supervised binding assays for CB1 and CB2. V.K. conceived the study and supervised all of its computational aspects. All of the authors contributed to writing and editing the manuscript.

(a) The number of hits at each score threshold from V-SYNTHES and standard VLS (b) Enrichment in V-SYNTHES vs. Standard VLS at different score thresholds, with the red x-mark showing threshold that yields 100 V-SYNTHES hits in the two-component library.

Boston, MA /PRNewswire/ - Image-guided surgery systems that provide real-time guidance for minimally invasive spine surgery can help improve patient outcomes, but these systems are costly for many hospitals. Surgeons may rely on checking implant placement with multiple static X-ray images that do not provide the real-time guidance of navigation. A new visualization option from DePuy Synthes Spine*, the KICK System with FluoroExpress Software Module, being showcased here at the North American Society Spine Meeting (NASS), aims to improve access to affordable advanced imaging technology so that surgeons can confirm proper placement of spinal implants while saving time in the operating room.

The KICK System is compatible with the VIPER System and the EXPEDIUM Spine System of implants, enhancing visualization during minimally invasive and open procedures to treat a broad range of spinal disorders.

"Building on our commitment to enabling technologies, the KICK System enhances less invasive surgery for the clinician who may not have access to expensive 3D imaging systems, but recognizes the need for advanced imaging to support a successful fusion procedure and help improve patient outcomes," said Dan Wildman, Platform Leader, DePuy Synthes Spine. "Through solutions such as the KICK System, we are improving access to care and creating and delivering clinical and economic value to healthcare systems worldwide."

In recognition of the need to broaden access to image-guided surgery in spine, the AO Foundation's technical commission (AOTK) approved the use of the KICK System in AO education courses. The KICK System is the first advanced visualization technology in spine to be approved by the AO Foundation, providing an opportunity for more surgeons around the world to be trained on image-guided surgery. DePuy Synthes and the AO Foundation have a longstanding collaboration, which helps deliver world-class education and supports innovation to improve patient outcomes and increase efficiency of care.

About DePuy Synthes Companies

DePuy Synthes Companies, Part of the Johnson & Johnson Family of Companies, provides one of the most comprehensive orthopaedic solutions in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

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