Second Generation Drug Eluting Stents Essay

963 words - 4 pages

The best source detailing the intended mechanism of the Synex implant is the manufacturer’s instruction guide to the performing surgeon (taken from and the following description is a condescend account of this material (does this pass as referencing?). Please note the specific guide referenced refers to the generic Synex system rather than the type II model specifically, though the core mechanism remains the same.
The intended mechanism of the Synex 2 is as such. After the surgeon has performed the corpectomy, they will measure the height of the gap created in the spine and use this information to select which specific size of implant is to be used. The implant chosen is then packed with bone graft to aid osseointegration (the central chamber of the device is hollow, referred to in the guide as the ‘cage’). It is then inserted into the spine, ideally centred on the vertebral endplate with a number of millimetres room between the device and the bone structure. The height of the device is adjustable on account of the central chamber being retractable and expandable. Once lodged the surgeon uses customised forceps to extend the central chamber of the implant, which is held in place by ratchets. This is essentially a simple mechanism, not far removed from that of a carjack, for instance. Once the correct calibration has been set, the device is locked into place by turning a key which would prevent movement of the ratchets, preventing retraction of the device upon assertion of pressure.
The implant is then packed with further bone graft before a supplementary support system is implanted to give additional support (please note that while the vertebral body device system (the Synex) is dependent upon this supplemental system for safe, correct function, the supplementary system is a stand-alone device).
As stated above, this procedure is taken from a generic Synex guide, and not specifically that of the Synex 2. But the unique feature of the Synex 2 was its improved kinematics, a feature not directly related to its specific mechanism of failure (this is discussed below/in section X.x)
Mechanism of Failure
Neither the FDA nor the Synthes statement goes far in explaining the mechanism of failure. In addition, although the Synex 2 is referred to in journal papers, its failure does not seem to be covered. This would be logical; the defect only became apparent in late 2009, and as such any paper encompassing this would most likely be yet to reach review. In addition, of the papers found with references to the Synex 2, all but one dated back to 2007 or before (comfortably pre-dating the recall) and the remaining paper was submitted 7 months after recall.
In light of this, the key resource in reviewing the exact mechanism of failure has been the Manufacturer and User Facility Device Experience (MAUDE). This service, provided by the FDA, effectively serves as a compendium of reports citing complaints against medical devices. Compiling these...

Find Another Essay On Second Generation Drug-Eluting Stents

How Coronary Heart Disease Affects Life

2238 words - 9 pages (Libby & Theroux, 2005, p.5). Second, tissue factor (TF) produced by macrophages and smooth muscle cells (SMC) activates the coagulation cascade (Toschi, Gallo, Lettino et al, 1997). The disrupted plaque thereby represents a “solid state” stimulus to both thrombosis and coagulation: these pathways reinforce each other, as thrombin generation amplifies the activation of platelets and other cells in the lesion (Libby & Theroux, 2005, p.5). In addition

Flying With Prozac Essay

1089 words - 4 pages main reasons. One, it has fewer side effects than other drugs like it, in their second generation antidepressant class. MAO or Monoamine inhibitors and tricyclics typically have more side effects than Prozac and often become intolerable antidepressant drugs. Two, along with being a drug to conquer depression, Prozac treats eating disorders and obsessive compulsive disorders. The FDA actually approved the drug in late 1993 for treating eating

nanotechnology in medicine

1179 words - 5 pages Drexler’s 1991 doctoral thesis at MIT was revised and published as the book Nanosystems: Molecular Machinery Manufacturing and Computation. As pointed out by both Feynman and Drexler, nanotechnology can be found within almost every type of manufacturing field. We are now seeing nanotech within field such as Food and Drug, Electronics, Manufacturing and Medical. According to recent reports, food is considered to be nanofood when nanoparticles

comprehensive drug abuse prevention and control act

949 words - 4 pages increasing problem. Marijuana, acid, and heroin were being used liberally in the 1960s by a generation that embraced drugs as part of a new cultural movement. Later in 1969, studies would link drug use with crime. People looked to the government to aid the situation. In 1970, the Narcotics Treatment Administration was founded to try to control drug use. That same year President Richard Nixon established the Comprehensive Drug Abuse Prevention

Psychopharmacology: The History, Techniques and Practical Application in Schizophrenia

1277 words - 6 pages relief from the sixth second generation drug one of the older forms of medication such as Chlorpromazine, Mellaril or Haldol should be used. At no point in the patient’s treatment should more than one antipsychotic drug be used at a time. If the patient response well to medication the medication should be continued and monitored for a period of at least six months. After a period of at least twelve consecutive months of no psychotic symptoms the

Future of "Big Pharma"

2421 words - 10 pages passes.ALTERNATIVE SOLUTIONS1.) Ownership in Generic Drug CompaniesUphold ownership with the generic companies thus ensuring suppose to get done correctly serving pharmaceutical interestAnalysisGive the pharmaceutical companies which of the expired patent drug to produce to and protect to best sure the overall pharmaceutical interest.2.) Line extensionInclude reformulation, next generation product development, innovative delivery, new combinations and new

A Generation Set Aside

1282 words - 5 pages described as the "Misunderstood Generation." They are the generation that dealt with and are still dealing with broken homes, drug addiction, AIDS, and bleak futures. A great deal of the young people in this "Misunderstood Generation" think very little about the future or present issues. This generation has lost sight of long terms goals and the idea that hard work pays off in the end. Instead, the people in this generation concern themselves only

Drugs - Does America Have a Future?

1232 words - 5 pages , tobacco, and alcohol are 266 times more likely to use cocaine than those who do not use those three substances. Children who use drugs learn less, are absent from school more often, quit school more frequently, and are involved in more gang activity than children who do not use drugs. Again, more drugs, obtained more easily would lead to even more problems with our next generation of citizens. During children's formative years, drug use can

What is Pharmacology?

901 words - 4 pages year. More history would include that in 1964, Propanol became the first specific adrenergic receptor blocking agent. It became a major therapy for Angina Pectoris, Cardiac Arrhythmia’s, hypertension and essential tremor. It ended the long drought in new heart medicines because of this. Furthermore, second generation drugs such as Atenolol and Metaprolol are receptors located in the heart muscle developed in the 1970’s. All of the above


1688 words - 7 pages further forward in myriad ways – if we let them” (Palfrey). The Millennials were raised by the baby boomers, arguably the second largest generation in history. Both of these generations have set many milestones when it comes to generational progresses. There comes a time when the similarities end, and the new generation breaks out from the old. The time has come for the Millennials to become self-sustaining adults. However, many young people

Causes of teenagers' drug abuse

497 words - 2 pages needs. Therefore, un properly guided by parents, teens are more easily misled. Otherwise, they will have, at least, second thought before using drugs rather than jumping at it at first glance. What's more, after a period of time, parents may not be aware of the warning signs that their children show before it's too late. Worse all the effect may be irreversible.Influence from bad friends also contributes, no in small part, to drug abuse. You need

Similar Essays

Cost Effectiveness Analysis Of Coronary Artery Bypass Grafting Compared With Drug Eluting Stents In Multivessel Coronary Artery Disease: An Econom

1059 words - 5 pages Strategies to be compared CABG is a surgery using healthy artery or vein to graft healthy vessels to the blocked coronary artery to construct a new pathway for oxygen rich blood. It is inherently invasive, complex, and highly risky . [9,11] DES is a kind of PCI which is transported to diseased coronary arteries and open up the narrowed or blocked arteries, meanwhile is able to release the drug slowly to inhibit the cell proliferation so as to

Percutaneous Transluminal Coronary Angioplasty Essay

2255 words - 9 pages the development of second-generation drug eluting stents [6] Second generation DES differ from first generation DES. The second generation DES gain valuable new characteristics, for instance most of the second generation DES possess a thin, biocompatible polymer with optimal flexibility, deliverability and freedom from structural fractures. Other characteristic include a low late loss and freedom from hypersensitivity reactions or late

The History Of Invasive And Interventional Cardiology

2241 words - 9 pages Stephen Hales' proposal of blood pressure and equine artery insertion experiment through use of catheters. N/A. "History of Angioplasty Timeline." Angioplasty.Org. Angioplasty.Org, n.d. Web. 22 Mar. 2014. . A timeline of the developments and surgeries that were done throughout history that led to the drug-eluting stents and interventional devices we have today in our era. Ponti, R. De, M. Zardini, C

J&J: Thriving For Over A Century

1185 words - 5 pages $3.7 billion, which was J&J’s largest acquisition to date. DePuy was a leader in orthopedic products, such as hip replacement devices. “J & J had been a pioneer in the market for coronary stents, devices used to keep arteries open following angioplasty, but its stent sales fell from $700 million in 1996 to just over $200 million in 1998 after competitors introduced second-generation stents and J & J did not” (Company Histories). The company was