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News Article | May 9, 2017
Site: www.businesswire.com

TOLEDO, Ohio--(BUSINESS WIRE)--NAMSA, the world’s only Medical Research Organization (MRO) that accelerates medical device development through integrated laboratory, clinical and consulting services, announced today that it has been recognized for excellence in clinical research and honored as a 2017 “CRO Leadership Award” winner. The CRO Leadership Awards are issued by Life Science Leader magazine and are based on data gathered by Industry Standard Research, a full-service biotechnology market research firm. Recipients of this prestigious award are selected based on data-driven feedback from those who have recently utilized clinical services in 27 key CRO performance categories, including Compatibility, Capabilities, Expertise, Quality and Reliability. “The CROs receiving an award this year are truly at the top of their class, and are deserving of the recognition they receive. Being ranked a top performer demonstrates a level of expertise and commitment to clinical trials and an ability to serve the needs of biopharmaceutical companies and their patients. Medical device sponsors can now make better-informed decisions when selecting a trusted, performance-driven CRO to assist in their clinical trials,” stated Ed Miseta, Executive Editor, Life Science Leader. “NAMSA is incredibly proud to be recognized by fellow industry executives as a leading CRO. This significant recognition is a direct result of our laser-like focus on accelerating medical device development and commercialization efforts for thousands of clients worldwide,” said John Gorski, NAMSA President & CEO. For nearly 50 years, NAMSA has focused on helping thousands of global customers succeed by offering the most critical services required to accelerate time-to-market and reduce costs for medical device research. Consistently recognized as a leader in medical device development – with a proven and established track record – NAMSA continuously places a dedicated focus on assisting clients in bringing life-changing therapies to the marketplace in the most efficient manner possible. Gorski continued, “Our experienced teams consistently deliver superior results for clients throughout the full spectrum of product development, including clinical research. By combining the knowledge of our dedicated Associates with our translational research approach, customers not only achieve clinical endpoints more quickly, but are also able to make more effective key commercialization decisions that lead to success.” NAMSA operates 13 offices throughout North America, Europe, the Middle East and Asia, and employs nearly 1,000 highly-experienced laboratory, clinical and consulting Associates. 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.


TOLEDO, Ohio & FT. LAUDERDALE, Fla.--(BUSINESS WIRE)--NAMSA®, the world’s only Medical Research Organization (MRO®) that accelerates medical device development through integrated laboratory, clinical and consulting services, is pleased to announce its partnership with NAGLREITER™ Medical Device Development Organization (MDDO), a high-growth medical device design, development and manufacturing firm. For nearly 50 years, NAMSA has focused on offering the most critical services required to accelerate time-to-market and reduce costs for medical device research clients across the world. Consistently recognized as a pioneer in medical device development – most recently with the honor of the “CRO Leadership Award,” presented by Life Science Leader magazine – NAMSA has a proven and established track record of delivering expedited results through the utilization of its translational research methods. NAGLREITER, similarly placing a significant concentration on providing efficacious customer outcomes, applies an integrated approach within its design, development and manufacturing service offerings. Providing end-to-end solutions for over 20 years, NAGLREITER focuses on technical and design alternatives that reduce costs and fast-track timelines that move clients into device production as quickly as possible. This partnership, drawing upon a combined 70 years’ experience in assisting thousands of customers to successfully commercialize products throughout the world, will now provide early-stage medical device firms a single source, power house solution through its combined full service offering. John Amat, NAMSA’s Chief Commercial Officer, said in support of the collaboration, “We are extremely excited about this unique partnership that will result in more predictable development timelines, increased cost savings and unparalleled time-to-market for device firms. NAGLREITER’s ‘Product Lifecycle Management’ methodology of innovation perfectly complements NAMSA’s ‘MRO Approach.’ Together, we will be able to more effectively drive start-up device programs and appropriately address the challenges and risks that these organizations face due to fragmented resources and increasingly complicated regulatory landscapes.” President of NAGLREITER, Brett Naglreiter, also commenting on the collaboration, stated, “NAGLREITER’s year-over-year success has opened up this exclusive opportunity to join forces with the leader in global medical device research. We fully expect our partnership to provide customers with further efficiencies that result from having access to a comprehensive portfolio of development resources and commercialization services that are managed through a single source.” NAMSA and NAGLREITER look forward to providing early-stage medical device organizations with a unique, world-class solution that will allow them to bring life-changing therapies to the marketplace in the most efficient manner possible. Medical device firms wishing to learn more about this partnership program may contact us at info@namsa.com or (866) 666-9455. NAMSA is the world’s only Medical Research Organization (MRO) that accelerates 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. NAGLREITER Medical Device Development Organization (MDDO) is a trusted partner for concept incubation, design, development and manufacturing engineering services within the Medtech industry. NAGLREITER prides itself on providing world-class services and employing a uniquely flexible business model to do so. NAGLREITER’s ‘The Right Path. With You’ business philosophy exemplifies the company’s commitment to partnering with clients in any way they require to yield the best possible outcomes. Based in the Ft. Lauderdale area in Miramar, Florida, NAGLREITER partners with medical device companies within the U.S. and abroad.


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.


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


Purvinis G.,Batelle Memorial Institute | 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.

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