DFINE, Inc.
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DFINE, Inc.
DFINE, Inc. was an American medical device company with headquarters in San Jose, California. It was known for its development of minimally invasive therapeutic devices built upon a radiofrequency platform for the treatment of spinal diseases. The platform included two applications, the StabiliT Vertebral Augmentation System for the treatment of vertebral compression fractures and the STAR Tumor Ablation System for pain relief treatment of metastatic spinal tumors. History DFINE was founded in 2004 in San Jose, California. It has had five rounds of funding since inception. The first being $35 million in 2009 led by Prospect Venture Partners. In January 2010 it received an additional $2.8 million. It received $36.2 million in equity finance in July 2010, led by Split Rock Partners with participation from OrbiMed, Prospect Venture Partners, and Vanguard Ventures. Its fourth round was $25 million with an additional $1.8 million coming in April 2012. In 2011, DFINE was awarded a ...
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San Jose, California
San Jose, officially San José (; ; ), is a major city in the U.S. state of California that is the cultural, financial, and political center of Silicon Valley and largest city in Northern California by both population and area. With a 2020 population of 1,013,240, it is the most populous city in both the Bay Area and the San Jose–San Francisco–Oakland, CA Combined Statistical Area, San Jose-San Francisco-Oakland Combined Statistical Area, which contain 7.7 million and 9.7 million people respectively, the List of largest California cities by population, third-most populous city in California (after Los Angeles and San Diego and ahead of San Francisco), and the List of United States cities by population, tenth-most populous in the United States. Located in the center of the Santa Clara Valley on the southern shore of San Francisco Bay, San Jose covers an area of . San Jose is the county seat of Santa Clara County, California, Santa Clara County and the main component of the San ...
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Radiofrequency Ablation
Radiofrequency ablation (RFA), also called fulguration, is a medical procedure in which part of the electrical conduction system of the heart, tumor or other dysfunctional tissue is ablated using the heat generated from medium frequency alternating current (in the range of 350–500 kHz). RFA is generally conducted in the outpatient setting, using either local anesthetics or conscious sedation anesthesia. When it is delivered via catheter, it is called radiofrequency catheter ablation. Two important advantages of radio frequency current (over previously used low frequency AC or pulses of DC) are that it does not directly stimulate nerves or heart muscle and therefore can often be used without the need for general anesthesia, and that it is very specific for treating the desired tissue without significant collateral damage; due to this, it is gaining in popularity as an alternative for eligible patients who do not want to undergo surgery. Documented benefits have led to RFA ...
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American Companies Established In 2004
American(s) may refer to: * American, something of, from, or related to the United States of America, commonly known as the "United States" or "America" ** Americans, citizens and nationals of the United States of America ** American ancestry, people who self-identify their ancestry as "American" ** American English, the set of varieties of the English language native to the United States ** Native Americans in the United States, indigenous peoples of the United States * American, something of, from, or related to the Americas, also known as "America" ** Indigenous peoples of the Americas * American (word), for analysis and history of the meanings in various contexts Organizations * American Airlines, U.S.-based airline headquartered in Fort Worth, Texas * American Athletic Conference, an American college athletic conference * American Recordings (record label), a record label previously known as Def American * American University, in Washington, D.C. Sports teams Soccer * B ...
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Neoplasm
A neoplasm () is a type of abnormal and excessive growth of tissue. The process that occurs to form or produce a neoplasm is called neoplasia. The growth of a neoplasm is uncoordinated with that of the normal surrounding tissue, and persists in growing abnormally, even if the original trigger is removed. This abnormal growth usually forms a mass, when it may be called a tumor. ICD-10 classifies neoplasms into four main groups: benign neoplasms, in situ neoplasms, malignant neoplasms, and neoplasms of uncertain or unknown behavior. Malignant neoplasms are also simply known as cancers and are the focus of oncology. Prior to the abnormal growth of tissue, as neoplasia, cells often undergo an abnormal pattern of growth, such as metaplasia or dysplasia. However, metaplasia or dysplasia does not always progress to neoplasia and can occur in other conditions as well. The word is from Ancient Greek 'new' and 'formation, creation'. Types A neoplasm can be benign, potentially ma ...
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Interventional Radiology
Interventional radiology (IR) is a medical specialty that performs various minimally-invasive procedures using medical imaging guidance, such as x-ray fluoroscopy, computed tomography, magnetic resonance imaging, or ultrasound. IR performs both diagnostic and therapeutic procedures through very small incisions or body orifices. Diagnostic IR procedures are those intended to help make a diagnosis or guide further medical treatment, and include image-guided biopsy of a tumor or injection of an imaging contrast agent into a hollow structure, such as a blood vessel or a duct. By contrast, therapeutic IR procedures provide direct treatment—they include catheter-based medicine delivery, medical device placement (e.g., stents), and angioplasty of narrowed structures. The main benefits of interventional radiology techniques are that they can reach the deep structures of the body through a body orifice or tiny incision using small needles and wires. That decreases risks, pain, an ...
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Cancer Pain
Pain in cancer may arise from a tumor compressing or infiltrating nearby body parts; from treatments and diagnostic procedures; or from skin, nerve and other changes caused by a hormone imbalance or immune response. Most chronic (long-lasting) pain is caused by the illness and most acute (short-term) pain is caused by treatment or diagnostic procedures. However, radiotherapy, surgery and chemotherapy may produce painful conditions that persist long after treatment has ended. The presence of pain depends mainly on the location of the cancer and the stage of the disease. At any given time, about half of all people diagnosed with malignant cancer are experiencing pain, and two-thirds of those with advanced cancer experience pain of such intensity that it adversely affects their sleep, mood, social relations and activities of daily living. With competent management, cancer pain can be eliminated or well controlled in 80% to 90% of cases, but nearly 50% of cancer patients in the develo ...
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Targeted Radiofrequency Ablation
Targeted radiofrequency ablation (also written t-RFA) is a minimally invasive procedure to treat severe pain and discomfort caused from metastatic tumors in the vertebral body of the spine. This procedure uses radiofrequency energy to target and ablate a specific spinal tumor, causing it shrink and reduce the pressure on the surrounding nerves and tissues. The procedure minimizes damage to the vertebrae and surrounding tissues. It is used as a palliative therapy rather with the intention of treating the cancer itself. History Targeted radiofrequency ablation was first developed by DFINE, Inc., a medical device company based in San Jose, California. Its product, the STAR Tumor Ablation System received 510(k) clearance from the United States Food and Drug Administration in August 2010. It is cleared for sale in the US and CE marked in Europe. The procedure was first performed at the James Graham Brown Cancer Center located at the University of Louisville Hospital in March 2012 ...
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Kyphoplasty
Vertebral augmentation, including vertebroplasty and kyphoplasty, refers to similar percutaneous spinal procedures in which bone cement is injected through a small hole in the skin into a fractured vertebra in order to relieve back pain caused by a vertebral compression fracture. After decades of medical research into the efficacy and safety of vertebral augmentation, there is still a lack of consensus regarding certain aspects of vertebroplasty and kyphoplasty. Procedure Vertebroplasty and kyphoplasty are the two most common procedures for spinal augmentation. These medical terms are classical compounds of the suffix '' -plasty'' meaning "molding or shaping surgically" (from Ancient Greek '' plastós'' "molded, formed") and the prefixes '' vertebro-'' "vertebra" (from Latin '' ''vertebra'' "joint, joint of the spine") and ''kypho-'' "humped; stooping forward" (from Ancient Greek '' kyphos'' "crooked"). Vertebroplasty Vertebroplasty is typically performed by a spine surgeon ...
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Radiofrequency Targeted Vertebral Augmentation
Radiofrequency targeted vertebral augmentation (also written as RF-TVA) is a form of kyphoplasty that uses radiofrequency heat to control the viscosity of polymethylmethacrylate cement and deliver it into the vertebral body to treat vertebral compression fractures. Procedure Radiofrequency targeted vertebral augmentation is a minimally invasive procedure designed to preserve good bone while performing vertebral augmentation (sometimes referred to as kyphoplasty). With traditional kyphoplasty, a balloon is used to create a space within the cancellous bone and then cement is injected into the space. The RF-TVA procedure is different in that a physician directs a small navigational canula into the vertebra and creates a small pathways for the cement as opposed to using a balloon. This process preserves more of the healthy canncellous bone. The pathways are then filled with ultra-high viscosity bone cement which then permeates into the surrounding bone, stabilizing the fracture and ...
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European Economic Area
The European Economic Area (EEA) was established via the ''Agreement on the European Economic Area'', an international agreement which enables the extension of the European Union's single market to member states of the European Free Trade Association. The EEA links the EU member states and three EFTA states (Iceland, Liechtenstein, and Norway) into an internal market governed by the same basic rules. These rules aim to enable free movement of persons, goods, services, and capital within the European single market, including the freedom to choose residence in any country within this area. The EEA was established on 1 January 1994 upon entry into force of the EEA Agreement. The contracting parties are the EU, its member states, and Iceland, Liechtenstein, and Norway. The EEA Treaty is a commercial treaty and differs from the EU Treaties in certain key respects. According to Article 1 its purpose is to "promote a continuous and balanced strengthening of trade and economic relati ...
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CE Marking
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards. The mark indicates that the product may be traded freely in any part of the European Economic Area, regardless of its country of origin. It consists of the CE logo and, if applicable, the four digit identification number of the notified body involved in the conformity assessment procedure. "CE" is the abbreviation of ( French for "European conformity"). Meaning The mark on a product indicates that the manufacturer or importer of that product affirms its compliance with the relevant EU legislation and the product may be sold anywhere in the European Economic Ar ...
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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), but 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 not d ...
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