Biophan Identifies a Major Cause of Pacemaker Heating Controversy.ROCHESTER, N.Y. -- Important Product Safety Information to be Exhibited at Heart Rhythm Noun 1. heart rhythm - the rhythm of a beating heart cardiac rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the Society's 26th Annual Scientific Session in New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded , LA, May 5 - 8 Biophan Technologies, Inc. (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : BIPH BIPH Bogomoletz Institute of Physiology (National Academy of Sciences; Ukraine) ), a developer of next-generation medical technology, today announced the results of its recent scientific studies that help to explain the widely varying reports on the Magnetic Resonance Imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ) safety of implanted medical devices such as pacemakers, defibrillators, neurostimulators, and other devices. These important findings, disclosed in part today on Biophan's website, will be a subject of discussion with multiple medical device manufacturers next week at the Heart Rhythm Society annual meeting in New Orleans. Michael Weiner Michael Weiner can refer to:
the seven decades of Eleanor Pargiter’s life. [Br. Lit.: Benét, 1109] See : Time worldwide scientific community has been divided over whether there is or is not a real safety problem. Biophan has identified a major inconsistency in the method of testing used by the industry to assess pacemaker heating during MRI, which helps to account for the wide variation of results observed in lead heating." Biophan results revealed today indicate that some of the unintentional variance seen in testing is due to limitations in the methods of testing and the very complicated physics associated with MRI. Biophan has worked for several years with some of the leading industry experts to better understand MRI-induced heating phenomena at the critical pacemaker-tissue interface. Biophan scientists have characterized a wide array of variables related to devices, patients, MRI scan parameters, and temperature measurement techniques that can affect lead heating. For example, testing has determined that maximum heating occurs slightly into the tissue and not at the tip of the electrode where heating is typically measured, and that different types of approved temperature measurement probes can significantly understate un·der·state v. un·der·stat·ed, un·der·stat·ing, un·der·states v.tr. 1. To state with less completeness or truth than seems warranted by the facts. 2. actual heating due to their design. When more accurate and more precise temperature measurement protocols are used, physiologically significant temperature increases well in excess of currently allowable limits are observed. To view graphs depicting the results of these experimental studies, please visit http://www.biophan.com/042905MRISafety.htm. The data released today reveal some of the results from Biophan's recent experimental studies. This data include studies of the temperature generated by a device and its dependence upon the location of the patient and device within the MRI scanner. Moving the pacemaker lead as little as 3 to 4.3 inches within the scanner can result in an increase in temperature at the tip of the lead of over 10 degrees Celsius, enough to cause significant tissue damage. This could occur clinically as a result of shifting a patient off center in the MRI bore to better image other tissues. Additional data, available on the Company's website, shows the effect of two different temperature probe designs, both of which are acceptable according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the current ASTM ASTM abbr. American Society for Testing and Materials testing standard. This information is significant since it also affects the way MRI-induced heating is measured in other devices, such as the safety testing of surgical tools used in the emerging field of MRI-guided interventional medicine. Biophan will be attending this year's Heart Rhythm Society Conference at a very critical period in the rapid growth of MRI. Pacing and Clinical Electrophysiology ("PACE") magazine, the official journal of the international cardiac pacing and electrophysiology society, recently published a diverse array of industry and FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. opinions on the potentially life-threatening issue of the safety of pacemakers and other implanted medical devices in MRI. Michael Weiner stated, "We were pleased to see this information in the recent PACE magazine editorials and articles. We are particularly pleased to see recognition both by key industry and government experts, sharing our view that MRI safety cannot be guaranteed until devices are designed from the ground up, with rigorous scientific testing." The Heart Rhythm 2005 conference is organized by the Heart Rhythm Society and will be attended by top research professionals and medical device executives from the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Europe, and Asia. For further information on the conference, please visit http://www.heartrhythm2005.org/index.asp About the Heart Rhythm Society Heart Rhythm Society, incorporated in 1979, has a membership of approximately 3,500 physicians and associated professionals from the United States, Canada, Mexico and many other countries. Heart Rhythm Society is the dominant professional group representing the allied specialties of cardiac pacing and cardiac electrophysiology Cardiac electrophysiology is the science of the mechanisms, functions, and performance of the electrical activities of specific regions of the heart. This term is usually used in describing studies of such phenomena by invasive (intracardiac) recording of spontaneous activity as in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and plays an important role not only in education but also as an intermediary between government regulatory agencies and members of the profession. Heart Rhythm Society offers Annual Scientific Sessions which include core curricula, symposia, clinical tutorials, meet-the-expert panels, mini-courses, Young Investigator presentations, debates, and state-of-the-art scientific abstracts. For more information, please visit www.hrsonline.org About Biophan Technologies Biophan develops and markets cutting-edge technologies designed to make biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. devices safe and compatible with the magnetic resonance imaging (MRI) environment. The Company develops enabling technologies for implanted medical systems such as pacemakers and interventional surgical devices such as catheters, guidewires, stents, and other implants to allow them to be safely and effectively imaged under MRI. The technology is also being used to create MRI contrast agents, and has expanded to include other applications, such as drug delivery and power systems derived from body heat. Four Biophan technologies include advances in nanotechnology and thin film coatings. Committed to growth through innovation and developmental leadership, Biophan and its licensors now hold a total of 114 U.S. patents, licenses, or applications. This total includes 36 issued U.S. patents, 6 recently-allowed applications that will issue as patents in the near future, and 72 pending applications at various stages of examination at the U.S. Patent and Trademark Office, plus international applications. The patents cover areas including nanotechnology (nanomagnetic particle coatings), radio frequency filters, polymer composites, thermoelectric ther·mo·e·lec·tric also ther·mo·e·lec·tri·cal adj. Characteristic of, resulting from, or using electrical phenomena occurring in conjunction with a flow of heat. materials for batteries generating power from body heat, and photonics. Biophan has joint development arrangements with Boston Scientific The Boston Scientific Corporation (NYSE: BSX) (abbreviated BSC), is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a range of interventional medical specialties, including interventional cardiology, peripheral interventions, (NYSE NYSE See: New York Stock Exchange :BSX BSX Bermuda Stock Exchange BSX Bandai Satellaview-X BSX Bicycle Super-X (Cross) ) and NASA's Ames Center for Nanotechnology. Biophan's goal is to make all biomedical devices capable of safely and successfully working with MRI, and delivering other technologies which will improve quality of life. For more information, please visit www.biophan.com. Cautionary Statement Regarding Forward-Looking Statements Certain statements included in this press release may constitute forward-looking statements within the meaning of applicable securities laws. These statements reflect what Biophan anticipates, expects, or believes may happen in the future. Biophan's actual results could differ materially from the outcome or circumstance expressed or implied by such forward-looking statements as a result of a variety of factors including, but not limited to: Biophan's ability to develop its technologies; the approval of Biophan's patent applications; the successful implementation of Biophan's research and development programs; the ability of Biophan to demonstrate the effectiveness of its technology; the acceptance by the market of Biophan's technology and products incorporating such technology, the ability of Biophan to effectively negotiate and enter into contracts with medical device manufacturers for the licensing of Biophan's technology; competition; the ability of Biophan to raise capital to fund its operating and research and development activities until it generates revenues sufficient to do so; and the timing of projects and trends in future operating performance, as well as other factors expressed from time to time in Biophan's periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with Biophan's periodic filings with the SEC which are incorporated herein by reference. The forward-looking statements contained herein are made only as of the date of this press release, and Biophan undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. |
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