Chasse-sur-Rhône, France
Chasse-sur-Rhône, France

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Brunner K.J.,St. Jude Medical | Bunch T.J.,Intermountain Medical Center | Mullin C.M.,NAMSA | May H.T.,Intermountain Medical Center | And 4 more authors.
Mayo Clinic Proceedings | Year: 2014

Objective To create a risk score using clinical factors to determine whom to screen and monitor for atrial fibrillation (AF).Patients and Methods The AF risk score was developed based on the summed odds ratios (ORs) for AF development of 7 accepted clinical risk factors. The AF risk score is intended to assess the risk of AF similar to how the CHA2DS2-VASc score assesses stroke risk. Seven validated risk factors for AF were used to develop the AF risk score: age, coronary artery disease, diabetes mellitus, sex, heart failure, hypertension, and valvular disease. The AF risk score was tested within a random population sample of the Intermountain Healthcare outpatient database. Outcomes were stratified by AF risk score for OR and Kaplan-Meier analysis.Results A total of 100,000 patient records with an index follow-up from January 1, 2002, through December 31, 2007, were selected and followed up for the development of AF through the time of this analysis, May 13, 2013, through September 6, 2013. Mean ± SD follow-up time was 3106±819 days. The ORs of subsequent AF diagnosis of patients with AF risk scores of 1, 2, 3, 4, and 5 or higher were 3.05, 12.9, 22.8, 34.0, and 48.0, respectively. The area under the curve statistic for the AF risk score was 0.812 (95% CI, 0.805-0.820).Conclusion We developed a simple AF risk score made up of common clinical factors that may be useful to possibly select patients for long-term monitoring for AF detection. © 2014 Mayo Foundation for Medical Education and Research.


News Article | February 15, 2017
Site: www.marketwired.com

The session will focus on various aspects of designing and conducting clinical trials for submission to the FDA, as well as, communicating with FDA during the pre-submission and submission process TORONTO, ON--(Marketwired - February 13, 2017) - On Tuesday, March 7, 2017, Xtalks will host a complimentary webinar featuring Richard Kotz, Senior Medical Research Scientist, Biostatistics from NAMSA as the keynote speaker. The advice provided during the session will be based on Richard Kotz's 25 years of experience gained as a statistical reviewer and biostatistics team leader at FDA's Center for Devices and Radiological Health. He, along with his team of biostatisticians, has reviewed 100's of medical devices for a wide variety of medical conditions. He has also participated in numerous FDA/sponsor meetings. Utilizing this experience and expertise, Mr. Kotz will share insights into key topics related to successful study design, with an emphasis on those trial elements which were most likely to lead to poorly designed and executed clinical trials. The discussion will provide best practices and tips on getting the most out of communications with the FDA and include a Q&A period with the audience. For more information or to register for this free webinar visit: Designing an Effective Clinical Trial Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies to private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit http://xtalks.com For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx


Nassar G.M.,Cornell University | Glickman M.H.,Sentara Heart Hospital | Mclafferty R.B.,University of Illinois at Springfield | Kevin Croston J.,North Memorial Medical Center | And 6 more authors.
Seminars in Dialysis | Year: 2014

Venous stenosis and occlusion are a major cause of vascular access dysfunction and failure. The HeRO Graft bypasses occlusion and traverses stenosis with outflow directly into the central venous circulation. A randomized, multicenter study was conducted to evaluate the efficacy and safety of the HeRO Graft relative to conventional AV grafts. The design was to enroll 143 patients in a 2:1 randomization ratio between HeRO and conventional AV control groups. Data on 72 subjects (52 HeRO Graft and 20 AV graft controls) were obtained. The HeRO Graft and control cohorts were comparable in baseline characteristics. Adequacy of dialysis, bacteremia rates, and adverse events were consistent between groups. Twelve month Kaplan-Meier estimates for primary and secondary patency rates were 34.8% and 67.6% in the HeRO Graft cohort, and 30.6% and 58.4% in the control cohort. There was no statistical difference in terms of patency between groups. The rates of intervention were 2.2/year for HeRO Graft and 1.6/year for the control (p = 0.100). Median days to loss of secondary patency was 238 for HeRO Graft versus 102 for the control (p = 0.032). The HeRO Graft appears to provide similar patency, adequacy of dialysis, and bacteremia rates to those of conventional AV grafts. © 2014 Wiley Periodicals, Inc.


Chambers J.W.,Mercy Hospital | Diage T.,NAMSA
Expert Review of Medical Devices | Year: 2014

Coronary lesions with severe (or heavy) calcification are classified as complex lesions and are known to carry lower success rates and higher complication rates following percutaneous coronary intervention. The Diamondback 360® Coronary Orbital Atherectomy System is the first and only device approved for use in the USA as a treatment for severely calcified coronary lesions to facilitate stent delivery and optimal deployment. Availability of this device provides a safe and effective option for physicians to improve treatment outcomes in this patient population with severely calcified coronary lesions. © 2014 Informa UK, Ltd.


Purvinis G.,Battelle | Cameron B.D.,University of Toledo | Altrogge D.M.,NAMSA
Journal of Diabetes Science and Technology | Year: 2011

Background: Since 1990, there has been significant research devoted toward development of a noninvasive physiological glucose sensor. In this article, we report on the use of optical polarimetry for the noninvasive measurement of physiological glucose concentration in the anterior chamber of the eye of New Zealand white (NZW) rabbits. Method: Measurements were acquired using a custom-designed laser-based optical polarimetry system in a total of seven NZW rabbits anesthetized using an isoflurane-only anesthesia protocol. Aqueous humor-based polarimetric measurements were obtained by coupling light through the anterior chamber of the eye. Blood glucose levels were first stabilized and then altered with intravenous dextrose and insulin administration and measured every 3-5 min with a standard glucometer and intermittently with a YSI 2300 glucose analyzer. Acquired polarimetric glucose signals are calibrated to measured blood glucose concentration. Results: Based on a total of 41 data points, Clarke error grid analysis indicated 93% in zone A, 7% in zone B, and 0% in zones C and D, with reference concentrations between 93 and 521 mg/dl. Errors in prediction are shown to be related to gross movement of the rabbit during the procedures, incurring time-varying corneal birefringence effects that directly affect the measured polarimetric signal. These effects can be compensated for with appropriate design modifications. Conclusions: An optical polarimetry technique was used for in vivo physiological glucose monitoring. The technique demonstrated provides a basis for the development of a noninvasive polarimetric glucose monitor for home, personal, or hospital use. © Diabetes Technology Society.


PubMed | NAMSA, Haga Ziekenhuis, Hegau Bodensee Klinikum Singen, Klinikum Frankfurt Hoechst and 10 more.
Type: Journal Article | Journal: Journal of cardiovascular electrophysiology | Year: 2016

Reliable detection and monitoring of atrial fibrillation (AF) is essential for accurate clinical decision making, which can now be done continuously with the introduction of implantable cardiac monitors (ICM) The DETECT AF study evaluated the performance of the Confirm DM2102 ICM (St. Jude Medical, St. Paul, MN, USA) to accurately detect and monitor AF.Ninety patients previously implanted with the ICM and with either suspected or known paroxysmal AF were enrolled at 12 centers in Germany and The Netherlands. At least 2 weeks after ICM implant, patients wore a Holter monitor for 4 days, while the ICM monitored for AF episodes lasting at least 2 minutes. Holter monitor data was analyzed by a blinded, independent core laboratory and compared to the ICM AF detections. Patient and episode sensitivity (SE), specificity (SP), positive predictive value (PPV), and negative predictive (NPV) were calculated using standard analysis and a generalized estimation equation method where appropriate.A total of 79/90 subjects (61% male, 65.7 9.6 years old) were included in the analysis, totaling 6,894 hours of Holter monitoring. Using a per patient analysis SE was 100%, PPV was 64.0%, SP was 85.7%, and NPV was 100%. Using a per episode analysis, SE was 94.0% and PPV was 64.0%. With an AF duration analysis, the SE was 83.9%, PPV was 97.3%, SP was 99.4% with an NPV of 98.5%.The SJM Confirm DM2102 can accurately and repeatedly detect paroxysmal AF episodes of at least 2 minutes in length.


PubMed | University Hospital Galway, Galway Clinic, National Institute of Agronomic Research and NAMSA
Type: Comparative Study | Journal: Vascular | Year: 2016

The multilayer flow modulator (MFM; Cardiatis, Isnes, Belgium) is a self-expandable mesh of braided cobalt alloy wires, used for treatment of aortic and peripheral aneurysms. To further improve our understanding of this novel technology, the endothelialization kinetics of the MFM was investigated and compared with those of two marketed single-layer stents. Five porcine animal models were used in which a total of 19 stents were implanted in the iliac and carotid arteries between one and five weeks before sacrifice. All 19 stents were successfully delivered. For all devices, nonsignificant signs of inflammation or thrombosis were noted, and there was no evidence of local intolerance. The MFM developed a thin layer of endothelial cells earlier and was associated with less neointimal development than the two single-layer stents. A differing phenomenon of integration was also revealed and hypothesized as endothelialization from adhesion of circulating endothelial progenitor cells, as well as adhesion from the arterial wall, and also by the differences in trauma exposed to the arterial wall.


News Article | November 3, 2016
Site: www.businesswire.com

TOLEDO, Ohio & SHANGHAI--(BUSINESS WIRE)--#clinicalresearch--NAMSA, the world’s only Medical Research Organization (MRO), is pleased to announce the opening of its 80,000 sq. ft. preclinical medical device research laboratory in Shanghai, China.


TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO), is pleased to announce the expansion of its global MRO Summit series. NAMSA’s MRO Summits will now offer further, complimentary educational events for medical device professionals wishing to gain direct access to consulting, testing and clinical resources worldwide. During its 50 year history, NAMSA has supported thousands of clients throughout all stages of the medical device development lifecycle, and has established a successful track record of accelerating time-to-market and reducing costs associated with clinical research and market approval. “The expansion of our MRO Summit series will allow us to share our global knowledge and scientific expertise on a wider scale by offering unique, real-world learning opportunities presented by NAMSA’s industry experts,” commented Christopher Rupp, NAMSA’s Director of Global Marketing. “We are extremely excited to present our shared experiences surrounding efficient medical device development, and to offer unique networking opportunities that allow medical device professional’s direct access to NAMSA’s knowledgeable, experienced thought leaders.” With over 15 events throughout 2017, attendees can expect to gain knowledge regarding best practices and suggested strategies for medical device development success across the following areas: To learn more about the MRO Summit series, with programs offered throughout the Americas, Asia and Europe – or to register – please visit the NAMSA website by clicking here. We also invite you to learn more about how NAMSA is assisting medical device clients to enhance patient safety and improve healthcare worldwide by contacting us at: clientcare@namsa.com. NAMSA is a Medical Research Organization (MRO), accelerating medical device product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines – consulting, regulatory, preclinical, toxicology, microbiology, chemistry, clinical and quality – to move clients’ products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.


MINNEAPOLIS & TOLDEO, Ohio--(BUSINESS WIRE)--#clinicalresearch--NAMSA Expands Medical Device Clinical and Consulting Services Presence in Minneapolis to Accommodate Growth

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