Biophan Releases Additional Data On Pacemaker Lead Heating; Company's Experimentation Further Refines Research into Problems of Pacemaker and Implantable Defibrillator Lead Heating.ROCHESTER, N.Y. -- 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 released additional technical information on its research into pacemaker and implantable defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a lead heating. The data reveal that the most prevalent heating occurs not at the electrode tip of a lead, but actually a short distance away from the electrode tip, in the tissue itself. Michael Weiner Michael Weiner can refer to:
chilling, cooling, temperature reduction - the process of becoming cooler; a falling temperature in tissue, at the interface between a highly electrically/thermally conductive medium (the lead) and a much lower electrically/thermally conductive medium (cardiac tissue). We have simulated this, and are continuing to refine the computer model to account not only for blood flow, but also the level of perfusion in the myocardium myocardium /myo·car·di·um/ (-kahr´de-um) the middle and thickest layer of the heart wall, composed of cardiac muscle. hibernating myocardium see myocardial hibernation, under and also in the fibrous cap The fibrous cap is a layer of fibrous connective tissue, which is thicker and less cellular than the normal intima. The fibrous cap contains macrophages and smooth muscle cells. that develops around the lead some time after implantation. "Our modeling to date indicates that heat is not created in the electrode itself, but as the electrical energy dissipates radially from the electrode tip and also from the helical helical /hel·i·cal/ (hel´i-k'l) spiral (1). hel·i·cal adj. 1. Of or having the shape of a helix; spiral. 2. Having a shape approximating that of a helix. fixation feature," said Mr. Weiner." The thin layer of tissue in immediate contact with the lead is close enough to the electrode that the electrode acts as a heat-sink; therefore, this thin layer does not experience the highest degree of heating, nor does the electrode body itself. As the current flows beyond this initial layer, the tissue is more poorly coupled to the electrode body thermally, and thus experiences more temperature rise. As the current flows even further outward in a radial manner, the cross-section of tissue it transits increases, so the heating effect falls off; in addition there is a much larger mass of tissue which contributes to the temperature rise decreasing. "What we see both in our computer model and in fiber-optic temperature measurements made with highly controlled positioning fixtures, is minimal heating of the electrode body, modest heating of the very first layer of tissue, much higher heating slightly further out and then the temperature increase falling off rapidly." The new data that Biophan released today is available on the Company's web site at: http://www.biophan.com/hpgraphic.html. The additional data released today added to the data that Biophan released on Friday regarding the sensitivity of testing procedures to the probe type and placement within the MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. bore. Biophan revealed that they are using a fluorescence-based fiber optic probe in order to eliminate any electrical interaction between the lead and measuring device which might change the conditions at the electrode. This type of probe is consistent with the existing ASTM ASTM abbr. American Society for Testing and Materials Standard. Many researchers report that they use a probe that has the sensing element in a ring around the optical fiber, which can be located 0.5mm or more away from the end of the probe. Biophan scientists use a probe with the sensing element at the very end, because the temperature changes significantly over very small distances, which can be influenced by the location of the sensing element within the probe. Biophan also revealed that the lateral position in the MRI bore has a significant effect on measured temperature increases. Biophan has tested both on-center and slightly off-axis to simulate the degree of clinically relevant offset that might be experienced, such as for a small individual who is being imaged for a non-central complaint, such as a right shoulder complaint. The degree of offset can create a much larger temperature increase, as indicated in the data that Biophan revealed on Friday showing that an offset of only several inches can result in physiologically significant increases in lead heating of as much as 10 degrees Celsius. "The existing ASTM Standard is somewhat qualitative regarding a) probe positioning, b) IPG/lead positioning, and c) position within the bore; we believe this is the reason there is such large variability in test results for the same MRI scan sequence reported by different examiners. Given the exponential relationship between temperature rise and the time before cell death (one second at 60 degrees Celsius for example) we believe that safety testing simply must be conducted over the full range of clinically relevant conditions," Mr. Weiner concluded. Mr. Weiner will provide the additional data at the 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 Sessions 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 . He will be one of five Biophan employees exhibiting and meeting with device manufacturers at the Heart Rhythm Society session. 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 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. , 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 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 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) 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 (NYSE NYSE See: New York Stock Exchange :BSX BSX Bermuda Stock Exchange BSX Bandai Satellaview-X BSX Bicycle Super-X (Cross) - News) 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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