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TOPS System
Premia Spine TOPS System is an FDA-approved mechanical implant that serves as an alternative to lumbar interbody fusion surgery after decompression. It was developed by Impliant and commercially launched by Premia Spine. Surgical procedure The TOPS System is a unitary implant composed of two titanium plates connected by an interlocking flexible articulating core. It has metal arms connecting horizontally to pedicles with four polyaxial screws. The device can be implanted after a standard decompression by removing the lamina and medial facets in a "posterior arthroplasty" procedure. The TOPS System replaces the bony and soft tissue removed during spinal decompression surgery and implants them at the affected spine segment to aid the patient's flexibility. Uses It is designed to treat patients diagnosed with common degenerative spinal diseases, including lumbar spinal stenosis, spondylolisthesis, and other facet joint conditions. One of the differences between the TOPS System ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Spinal Fusion
Spinal fusion, also called spondylodesis or spondylosyndesis, is a surgery performed by Orthopedic surgery#Practice, orthopaedic surgeons or neurosurgeons that joins two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, lumbar, or sacral) and prevents any movement between the fused vertebrae. There are many types of spinal fusion and each technique involves using bone grafting—either from the patient (autotransplantation, autograft), donor (allograft), or artificial bone substitutes—to help the bones heal together. Additional hardware (screws, plates, or Interbody fusion cage, cages) is often used to hold the bones in place while the graft fuses the two vertebrae together. The placement of hardware can be guided by fluoroscopy, Computer-assisted surgery, navigation systems, or Robot-assisted surgery, robotics. Spinal fusion is most commonly performed to relieve the pain and pressure from mechanical pain of the vertebrae or on th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Polyaxial Screw
A polyaxial screw is used for connecting vertebrae to rods in spinal surgery, particularly spinal fusion procedures. It is a type of screw whose spherical head is enclosed in a housing, which allows the screw a range of motion along several different axes relative to the housing. The ball joint allows the surgeon some flexibility in placing the screws. The screws are typically placed into the pedicle of the vertebra. It has also been hypothesized that polyaxial screws add a safety benefit by failing in the housing/screw interface before breaking in the shaft of the bone screw or in the orthopaedic rod. Unlike standard lateral mass plate and screw systems, the new cervical polyaxial screw and rod system easily accommodates severe degenerative cervical spondylosis Spondylosis is the degeneration of the vertebral column from any cause. In the more narrow sense, it refers to spinal osteoarthritis, the age-related degeneration of the spinal column, which is the most common caus ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Spinal Stenosis
Spinal stenosis is an abnormal narrowing of the spinal canal or neural foramen that results in pressure on the spinal cord or nerve roots. Symptoms may include pain, numbness, or weakness in the arms or legs. Symptoms are typically gradual in onset and improve with leaning forward. Severe symptoms may include loss of bladder control, loss of bowel control, or sexual dysfunction. Causes may include osteoarthritis, rheumatoid arthritis, spinal tumors, trauma, Paget's disease of the bone, scoliosis, spondylolisthesis, and the genetic condition achondroplasia. It can be classified by the part of the spine affected into cervical, thoracic, and lumbar stenosis. Lumbar stenosis is the most common, followed by cervical stenosis. Diagnosis is generally based on symptoms and medical imaging. Treatment may involve medications, bracing, or surgery. Medications may include NSAIDs, acetaminophen, anticonvulsants ( gabapentinoids) or steroid injections. Stretching and strengthen ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Spondylolisthesis
Spondylolisthesis is when one spinal vertebra slips out of place compared to another. While some medical dictionaries define spondylolisthesis specifically as the forward or anterior displacement of a vertebra over the vertebra inferior to it (or the sacrum), it is often defined in medical textbooks as displacement in any direction.Introduction to chapter 17 in: Page 250 in: Spondylolisthesis is graded based upon the degree of slippage of one vertebral body relative to the subsequent adjacent vertebral body. Spondylolisthesis is classified as one of the six major etiologies: degenerative, traumatic, dysplastic, wikt:isthmic, isthmic, pathologic, or post-s ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Facet Joint
The facet joints (also zygapophysial joints, zygapophyseal, apophyseal, or Z-joints) are a set of synovial joint, synovial, plane joints between the articular processes of two adjacent vertebrae. There are two facet joints in each functional spinal unit, spinal motion segment and each facet joint is innervated by the Meningeal branches of spinal nerve, recurrent meningeal nerves. Innervation Innervation to the facet joints vary between segments of the spinal, but they are generally innervated by medial branch nerves that come off the dorsal rami. It is thought that these nerves are for primary sensory input, though there is some evidence that they have some motor input local musculature. Within the cervical spine, most joints are innervated by the medial branch nerve (a branch of the dorsal rami) from the same levels. In other words, the facet joint between C4 and C5 vertebral segments is innervated by the C4 and C5 medial branch nerves. However, there are two exceptions: # T ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Breakthrough Therapy
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition; rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases. The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review. Requirements A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination wit ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Reuters
Reuters ( ) is a news agency owned by Thomson Reuters. It employs around 2,500 journalists and 600 photojournalists in about 200 locations worldwide writing in 16 languages. Reuters is one of the largest news agencies in the world. The agency was established in London in 1851 by Paul Reuter. The Thomson Corporation of Canada acquired the agency in a 2008 corporate merger, resulting in the formation of the Thomson Reuters Corporation. In December 2024, Reuters was ranked as the 27th most visited news site in the world, with over 105 million monthly readers. History 19th century Paul Julius Reuter worked at a book-publishing firm in Berlin and was involved in distributing radical pamphlets at the beginning of the Revolutions of 1848. These publications brought much attention to Reuter, who in 1850 developed a prototype news service in Aachen using homing pigeons and electric telegraphy from 1851 on, in order to transmit messages between Brussels and Aachen, in what today is Aa ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Lumbar Vertebrae
The lumbar vertebrae are located between the thoracic vertebrae and pelvis. They form the lower part of the back in humans, and the tail end of the back in quadrupeds. In humans, there are five lumbar vertebrae. The term is used to describe the anatomy of humans and quadrupeds, such as horses, pigs, or cattle. These bones are found in particular cuts of meat, including tenderloin or sirloin steak. Human anatomy In human anatomy, the five vertebrae are between the rib cage and the pelvis. They are the largest segments of the vertebral column and are characterized by the absence of the foramen transversarium within the transverse process (since it is only found in the cervical region) and by the absence of facets on the sides of the body (as found only in the thoracic region). They are designated L1 to L5, starting at the top. The lumbar vertebrae help support the weight of the body, and permit movement. General characteristics The adjacent figure depicts the general cha ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
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 assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of Archaeology, archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it was not until the Federal Food, Drug, and Cosmetic Act ( ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
