NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited by the Heart Rhythm Society (HRS) to present results of a recent clinical study showing that recurrent atrial fibrillation (AF) was accurately and timely detected in patients who used CardioBip™ for daily monitoring following catheter ablation procedures. The presentation, entitled "Long-term Intermittent Wireless Remote Monitoring of Reconstructed 12-Lead ECG in Post-Ablation AF Patients Using the CardioBip System", will be made at the 32nd Annual Scientific Sessions of the HRS, to be held in San Francisco, CA, May 4-7, 2011.
AF affects an estimated 1% of the worldwide population, with nearly three million AF patients in the US and six million AF patients in Europe. It is a serious medical condition that doubles mortality risk and increases risk of stroke by five-fold. Accordingly, such patients often need ambulatory monitoring to detect AF recurrences. Currently available AF monitoring devices have significant limitations, such as relatively few monitoring leads and the need to wear a device with attached wires and skin electrodes. CardioBip addresses these limitations as it does not employ any skin electrodes or wires. The handheld device conveniently records and wirelessly transmits information sufficient to reconstruct a full 12-lead ECG.
Vincent Renz, CEO of NewCardio, commented, "We are delighted to be presenting our latest CardioBip clinical study at the HRS Annual Scientific Meeting, a prestigious forum that is well-attended by cardiologists and electrophysiologists with a particular interest in novel solutions for long-term ambulatory cardiac monitoring. The exciting data from this study provide additional and very solid supporting evidence for our belief that CardioBip is exceptionally well-suited for long-term cardiac monitoring. There are more than 30 million patients – in the US and throughout the world - who have atrial fibrillation or other cardiac arrhythmias, and could benefit from using the CardioBip solution. We look forward to sharing the data with our HRS colleagues, and to building market awareness of CardioBip's efficacy, ease of use, and suitability for this important clinical need."
In the study, 21 patients who underwent catheter ablation for AF were given CardioBip devices and asked to provide daily transmissions for 60 days and additional transmissions whenever symptoms (such as palpitations or dizziness) developed. Patients also had 24-hour, continuous 12-lead ECG recordings (Holter monitors [HM]), a commonly-used method for AF surveillance, at 30 and 60 days post-procedure. Both CardioBip and HM data were reviewed by two independent, blinded cardiologists.
All 21 patients completed the full 60-day follow-up period and showed good compliance throughout, making an average of 2.2 transmissions per day. Twenty of 21 patients had at least one episode of recurrent AF detected by CardioBip. Most of these episodes were asymptomatic. Six of the 20 patients also had occurrence of atrial flutter (AFLT) detected. In contrast, only four and two patients had recurrent AF and AFLT detected by 12-lead HM, respectively. In all these six patients, AF and AFLT had already been detected by CardioBip – an average of 27 days earlier than detection by 12-lead HM. All symptomatic CardioBip transmissions were correlated with at least one rhythm irregularity (e.g. AF, AFLT, or premature beats).
Dr. Dorin Panescu, PhD, NewCardio's Chief Technical Officer, commented, "This is the third clinical study showing that CardioBip is an effective, accurate and patient-friendly solution for long-term monitoring of cardiac conditions. In particular, the study data show that CardioBip has the potential to contribute to clinical management of patients affected by atrial fibrillation."
Dr. Panescu continued, "NewCardio is committed to strengthening the CardioBip solution and to protecting its respective intellectual property worldwide. In addition to filing several CardioBip-related patent applications with the US Patent Office, NewCardio has aggressively filed respective PCT patent applications and had been issued core CardioBip patents in several other countries."
Each year, the HRS receives thousands of submissions from outstanding investigators throughout the world, but selects only about one-third for presentation. This is the third successive year that the HRS had invited scientists to present results from studies that used NewCardio's 3-D ECG solutions.
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