PALM BEACH, Florida, November 27, 2018 /PRNewswire/ --
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Thecardiology market within the biotech industry is being revitalized by advancements of Electrocardiographic technologies. North America dominates the global multi-lead Electrocardiographic machines market due to rising
BioSig Technologies, Inc. (NASDAQ:BSGM) BREAKING NEWS - BioSig Technologies, a medical device company developing a proprietary biomedical signal processing platform designed to address an unmet technology need for the $4.6 billion electrophysiology (EP) marketplace, today announced that the Company has signed an agreement with Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center in Austin, Texas to conduct First-in-Human studies using the PURE EP™ System. These First-in-Human studies are aimed at validating the key value proposition elements of the PURE EP™ System that have already been established in pre-clinical studies and published to date in a number of journals, including The Journal of Innovations in Cardiac Rhythm Management. Collected data and physician experience arising from the First-in-Human studies will be documented and presented in the form of publications, clinical abstracts or late-breaking news.
Commencement of First-in-Human studies is the initial step in the Company's targeted commercial launch of its first product, PURE EP™ System. The PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory. The PURE EP™ System aims to minimize noise and artifacts, and acquire high-fidelity cardiac signals. Improving fidelity of acquired cardiac signals may potentially increase the diagnostic value of these signals, thereby possibly improving accuracy and efficiency of the EP studies and related procedures. First-in-Human studies will be conducted at TCAI. Andrea Natale M.D., F.A.C.C., F.H.R.S., F.E.S.C., Executive Medical Director, Texas Cardiac Arrhythmia Institute at St. David's Medical Center will conduct the First-in-Human study. A world recognized leader in the field of electrophysiology, Dr. Natale is known as a dedicated clinician, academician and researcher. He is an author of over 600 publications related to treatments of arrhythmia. Prior to joining TCAI, Dr. Natale was a member of the Cardiovascular Medicine Department at the Cleveland Clinic from 1999 to 2007, and served as Section Head for the Department of Cardiac Pacing and Electrophysiology and as Medical Director for the Cleveland Clinic's Center for Atrial Fibrillation. In 2006, Dr. Natale was named to the Food and Drug Administration's Task Force on Atrial Fibrillation. "To better understand complex arrhythmia disease states, the ability to detect the smallest of electrical activity in various clinical situations has been a critical need for our industry. I am looking forward to the possibility that the PURE EP System will uncover these signals and advance treatment options so physicians can make more informed decisions for our patients," commented Dr. Natale. "BioSig reached another important milestone after achieving FDA clearance in August 2018 and uplisting to Nasdaq in September 2018. We opened an office in Austin, TX, earlier this year in anticipation of our present needs, and are now focused on providing TCAI full support during the First-in-Human use of our technology, which will preface our commercial launch in the U.S. in May 2019. Dr. Natale inspired the founding of our Company and has chaired our Scientific Advisory Board since 2011. We are proud to be working with Dr. Natale and his team during this important stage of our Company's growth," commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies. Read this and more news for BSGM at: https://www.financialnewsmedia.com/news-bsgm In other cardiac/heart health industry news of note:
Medtronic plc (NYSE:MDT) recently announced new data on the Heli-FX(TM) EndoAnchor(TM) system, which demonstrated durability, safety and efficacy in patients with complex aortic abdominal aneurysm (AAA) anatomy, particularly those with hostile aortic neck anatomies. The new data were unveiled in presentations at the 45th Annual Symposium of Vascular and Endovascular Issues (VEITHsymposium) in New York. The findings are based on three-year data from the primary prophylactic and therapeutic revision arms of the Medtronic ANCHOR registry - a global, multi-center, multi-arm, post-market registry evaluating the real-world applicability of the Heli-FX EndoAnchor System. "With Heli-FX, our focus continues to be on improving the lives of patients with complex aortic disease by broadening applicability of endovascular repair to patients who have traditionally been challenging to treat," said John Farquhar, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic. "These data further validate the use of EndoAnchor fixation as a long-term solution that enhances outcomes and durability in patients with complex aortic anatomies."
Abbott (NYSE:ABT) announced recently that the HeartMate 3™ Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians can now offer the HeartMate 3 system to patients not eligible for a transplant who will live with their device for the rest of their lives. More than 5.7 million Americans suffer from heart failure, and there are approximately 915,000 new patients diagnosed with the disease annually. For advanced heart failure patients who can no longer rely on earlier stage treatment options, LVAD's take the workload off a weakened heart by pumping blood through the body-providing crucial, life-saving support for patients awaiting a heart transplant or for those not able to receive one.
Johnson & Johnson (NYSE:JNJ) Medical Devices Companies* announced this year that Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmias, has enrolled and treated the first patient in its QDOT AF Study.** The study will evaluate the delivery of high power, short duration ablation with QDOT MICRO, a novel radiofrequency (RF) ablation catheter for the treatment of paroxysmal atrial fibrillation (AF). The first AF patient was treated successfully at OLV Hospital in Aalst, Belgium, one of eight centers in Europe as part of the study that will enroll up to 50 patients. An estimated 33 million people worldwide have been diagnosed with AF and its prevalence is projected to increase significantly as the population ages. Approximately 70 percent of patients with AF are between the ages of 65 and 85.
Boston Scientific (NYSE:BSX) announced this year that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia™ Drug-Eluting Vascular Stent System, specifically developed for the treatment of peripheral artery disease (PAD). The Eluvia stent utilizes a drug-polymer combination to offer sustained release of the drug paclitaxel for a one-year timeframe, designed to prevent tissue regrowth that might otherwise block the stented artery.
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