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News Article | May 26, 2017
Site: globenewswire.com

SOUTH JORDAN, Utah, May 26, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, announced today that it has appointed Thomas Gunderson to serve as a director of the Company. Gunderson recently retired from a 24-year career at Piper Jaffray where he covered numerous companies as a Senior Research Analyst for Medical Technology.  Prior to joining Piper Jaffray, he worked for 12 years at American Medical Systems, a private medical device company acquired by Pfizer in 1983.  Gunderson has served on several non-profit boards and is currently serving as Chairman of the Board of Directors of the Minneapolis Heart Institute Foundation, as a member of the Board of TransMedics, Inc., and as a director of the Abbott Northwestern Hospital Foundation. Gunderson was appointed by Merit’s Board of Directors to fill a vacancy which resulted from the resignation of Richard Edelman, who served as a director of Merit since the company’s founding and recently as Lead Director.  Merit’s Board of Directors also appointed Nolan Karras to assume the role of Lead Director. “We are pleased to have Thom Gunderson join our Board,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “We believe his broad experience in observing, analyzing and reporting on medtech companies will bring a seasoned perspective to the Board as we continually seek to represent the best interests of our shareholders.  We would like to publicly thank Dick Edelman for his many years of dedication and service to Merit’s Board.” ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore. FORWARD-LOOKING STATEMENTS Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted plans, revenues, net income, financial results or anticipated or completed acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission.  Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through completed, proposed or future transactions; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on Merit's liquidity or business operations resulting from its current debt agreements; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other countries; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States or other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in exchange rates;  concentration of a substantial portion of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.


News Article | May 26, 2017
Site: globenewswire.com

SOUTH JORDAN, Utah, May 26, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, announced today that it has appointed Thomas Gunderson to serve as a director of the Company. Gunderson recently retired from a 24-year career at Piper Jaffray where he covered numerous companies as a Senior Research Analyst for Medical Technology.  Prior to joining Piper Jaffray, he worked for 12 years at American Medical Systems, a private medical device company acquired by Pfizer in 1983.  Gunderson has served on several non-profit boards and is currently serving as Chairman of the Board of Directors of the Minneapolis Heart Institute Foundation, as a member of the Board of TransMedics, Inc., and as a director of the Abbott Northwestern Hospital Foundation. Gunderson was appointed by Merit’s Board of Directors to fill a vacancy which resulted from the resignation of Richard Edelman, who served as a director of Merit since the company’s founding and recently as Lead Director.  Merit’s Board of Directors also appointed Nolan Karras to assume the role of Lead Director. “We are pleased to have Thom Gunderson join our Board,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “We believe his broad experience in observing, analyzing and reporting on medtech companies will bring a seasoned perspective to the Board as we continually seek to represent the best interests of our shareholders.  We would like to publicly thank Dick Edelman for his many years of dedication and service to Merit’s Board.” ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore. FORWARD-LOOKING STATEMENTS Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted plans, revenues, net income, financial results or anticipated or completed acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission.  Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through completed, proposed or future transactions; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on Merit's liquidity or business operations resulting from its current debt agreements; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other countries; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States or other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in exchange rates;  concentration of a substantial portion of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.


News Article | May 26, 2017
Site: globenewswire.com

SOUTH JORDAN, Utah, May 26, 2017 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ:MMSI), a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy, announced today that it has appointed Thomas Gunderson to serve as a director of the Company. Gunderson recently retired from a 24-year career at Piper Jaffray where he covered numerous companies as a Senior Research Analyst for Medical Technology.  Prior to joining Piper Jaffray, he worked for 12 years at American Medical Systems, a private medical device company acquired by Pfizer in 1983.  Gunderson has served on several non-profit boards and is currently serving as Chairman of the Board of Directors of the Minneapolis Heart Institute Foundation, as a member of the Board of TransMedics, Inc., and as a director of the Abbott Northwestern Hospital Foundation. Gunderson was appointed by Merit’s Board of Directors to fill a vacancy which resulted from the resignation of Richard Edelman, who served as a director of Merit since the company’s founding and recently as Lead Director.  Merit’s Board of Directors also appointed Nolan Karras to assume the role of Lead Director. “We are pleased to have Thom Gunderson join our Board,” said Fred P. Lampropoulos, Merit’s Chairman and Chief Executive Officer.  “We believe his broad experience in observing, analyzing and reporting on medtech companies will bring a seasoned perspective to the Board as we continually seek to represent the best interests of our shareholders.  We would like to publicly thank Dick Edelman for his many years of dedication and service to Merit’s Board.” ABOUT MERIT Founded in 1987, Merit Medical Systems, Inc. is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.  Merit serves client hospitals worldwide with a domestic and international sales force totaling approximately 290 individuals.  Merit employs approximately 4,500 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia; Tokyo, Japan; and Singapore. FORWARD-LOOKING STATEMENTS Statements contained in this release which are not purely historical, including, without limitation, statements regarding Merit's forecasted plans, revenues, net income, financial results or anticipated or completed acquisitions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties such as those described in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission.  Such risks and uncertainties include risks relating to Merit's potential inability to successfully manage growth through acquisitions, including the inability to commercialize technology acquired through completed, proposed or future transactions; product recalls and product liability claims; expenditures relating to research, development, testing and regulatory approval or clearance of Merit's products and risks that such products may not be developed successfully or approved for commercial use; governmental scrutiny and regulation of the medical device industry, including governmental inquiries, investigations and proceedings involving Merit; reforms to the 510(k) process administered by the U.S. Food and Drug Administration; restrictions on Merit's liquidity or business operations resulting from its current debt agreements; infringement of Merit's technology or the assertion that Merit's technology infringes the rights of other parties; the potential of fines, penalties or other adverse consequences if Merit's employees or agents violate the U.S. Foreign Corrupt Practices Act or other laws or regulations; laws and regulations targeting fraud and abuse in the healthcare industry; potential for significant adverse changes in governing regulations; changes in tax laws and regulations in the United States or other countries; increases in the prices of commodity components; negative changes in economic and industry conditions in the United States or other countries; termination or interruption of relationships with Merit's suppliers, or failure of such suppliers to perform; fluctuations in exchange rates;  concentration of a substantial portion of Merit's revenues among a few products and procedures; development of new products and technology that could render Merit's existing products obsolete; market acceptance of new products; volatility in the market price of Merit's common stock; modification or limitation of governmental or private insurance reimbursement policies; changes in healthcare policies or markets related to healthcare reform initiatives; failure to comply with applicable environmental laws; changes in key personnel; work stoppage or transportation risks; introduction of products in a timely fashion; price and product competition; availability of labor and materials; fluctuations in and obsolescence of inventory; and other factors referred to in Merit's Annual Report on Form 10-K for the year ended December 31, 2016 and other materials filed with the Securities and Exchange Commission. All subsequent forward-looking statements attributable to Merit or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. Actual results will likely differ, and may differ materially, from anticipated results. Financial estimates are subject to change and are not intended to be relied upon as predictions of future operating results, and Merit assumes no obligation to update or disclose revisions to those estimates.


Maron B.J.,Minneapolis Heart Institute Foundation | Maron M.S.,Hypertrophic Cardiomyopathy Center | Semsarian C.,University of Sydney | Semsarian C.,Royal Prince Alfred Hospital
Journal of the American College of Cardiology | Year: 2012

Hypertrophic cardiomyopathy (HCM) is the most common familial heart disease with vast genetic heterogeneity, demonstrated over the past 20 years. Mutations in 11 or more genes encoding proteins of the cardiac sarcomere (>1,400 variants) are responsible for (or associated with) HCM. Explosive progress achieved in understanding the rapidly evolving science underlying HCM genomics has resulted in fee-for-service testing, making genetic information widely available. The power of HCM mutational analysis, albeit a more limited role than initially envisioned, lies most prominently in screening family members at risk for developing disease and excluding unaffected relatives, which is information not achievable otherwise. Genetic testing also allows expansion of the broad HCM disease spectrum and diagnosis of HCM phenocopies with different natural history and treatment options, but is not a reliable strategy for predicting prognosis. Interfacing a heterogeneous disease such as HCM with the vast genetic variability of the human genome, and high frequency of novel mutations, has created unforeseen difficulties in translating complex science (and language) into the clinical arena. Indeed, proband diagnostic testing is often expressed on a probabilistic scale, which is frequently incompatible with clinical decision making. Major challenges rest with making reliable distinctions between pathogenic mutations and benign variants, and those judged to be of uncertain significance. Genotyping in HCM can be a powerful tool for family screening and diagnosis. However, wider adoption and future success of genetic testing in the practicing cardiovascular community depends on a standardized approach to mutation interpretation, and bridging the communication gap between basic scientists and clinicians. © 2012 American College of Cardiology Foundation.


Maron B.J.,Minneapolis Heart Institute Foundation | Maron B.J.,Tufts Medical Center | Maron M.S.,Minneapolis Heart Institute Foundation | Maron M.S.,Tufts Medical Center
The Lancet | Year: 2013

Hypertrophic cardiomyopathy is a common inherited cardiovascular disease present in one in 500 of the general population. It is caused by more than 1400 mutations in 11 or more genes encoding proteins of the cardiac sarcomere. Although hypertrophic cardiomyopathy is the most frequent cause of sudden death in young people (including trained athletes), and can lead to functional disability from heart failure and stroke, the majority of affected individuals probably remain undiagnosed and many do not experience greatly reduced life expectancy or substantial symptoms. Clinical diagnosis is based on otherwise unexplained left-ventricular hypertrophy identified by echocardiography or cardiovascular MRI. While presenting with a heterogeneous clinical profile and complex pathophysiology, effective treatment strategies are available, including implantable defibrillators to prevent sudden death, drugs and surgical myectomy (or, alternatively, alcohol septal ablation) for relief of outflow obstruction and symptoms of heart failure, and pharmacological strategies (and possibly radiofrequency ablation) to control atrial fibrillation and prevent embolic stroke. A subgroup of patients with genetic mutations but without left-ventricular hypertrophy has emerged, with unresolved natural history. Now, after more than 50 years, hypertrophic cardiomyopathy has been transformed from a rare and largely untreatable disorder to a common genetic disease with management strategies that permit realistic aspirations for restored quality of life and advanced longevity.


Hauser R.G.,Minneapolis Heart Institute Foundation
Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology | Year: 2013

The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure. We searched the US Food and Drug Administration's (FDA's) Manufacturers and User Device Experience (MAUDE) database on 13 April 2012 using the simple search terms 'Riata ST Optim™ abrasion analysis' and 'Durata abrasion analysis'. Lead implant time was estimated by subtracting 3 months from the reported lead age. The MAUDE search returned 15 reports for Riata ST Optim™ and 37 reports for Durata leads, which were submitted by SJM based on its analyses of returned leads for clinical events that occurred between December 2007 and January 2012. Riata ST Optim™ leads had been implanted 29.1 ± 11.7 months. Eight of 15 leads had can abrasions and three abrasions were caused by friction with another device, most likely another lead. Four of these abrasions resulted in high-voltage failures and one death. One failure was caused by an internal insulation defect. Durata leads had been implanted 22.2 ± 10.6 months. Twelve Durata leads had can abrasions, and six leads had abrasions caused by friction with another device. Of these 18 can and other device abrasions, 13 (72%) had electrical abnormalities. Low impedances identified three internal insulation abrasions. Riata ST Optim™ and Durata ICD leads have failed due to insulation abrasions. Optim™ did not prevent these abrasions, which developed ≤ 4 years after implant. Studies are needed to determine the incidence of these failures and their clinical implications.


Sharkey S.W.,Minneapolis Heart Institute Foundation
Heart Failure Clinics | Year: 2013

This article provides a comprehensive review of the clinical features of takotsubo (stress) cardiomyopathy. The author discusses key features that distinguish this cardiomyopathy from acute coronary syndrome. This review includes detail of characteristic findings on electrocardiogram, biochemical testing, and cardiac imaging, as well as complications including congestive heart failure, arrhythmia, ventricular thrombi, and left ventricular outflow obstruction. The review concludes with a discussion of the proper treatment, long-term survival, and proposed pathophysiology. © 2013 Elsevier Inc.


Maron B.J.,Minneapolis Heart Institute Foundation | Estes III N.A.M.,Tufts University
New England Journal of Medicine | Year: 2010

In the past decade, the general public and the medical community have become more aware of commotio cordis as an important cause of sudden death. Commotio cordis occurs in otherwise healthy and active young people, typically during recreational and competitive sports but in some cases even during normal daily activities. A variety of experimental models indicate that if delivered at a particular moment in the cardiac cycle, even innocent-appearing precordial blows can trigger ventricular fibrillation and result in fatal commotio cordis events. Further efforts are needed to prevent these largely avoidable deaths by providing more education, better-designed athletic equipment (e.g., effective chest-wall protectors), and wider access to AEDs at organized athletic events. These strategies should result in a safer sports environment for our youth. Copyright © 2010 Massachusetts Medical Society. All rights reserved.


Maron B.J.,Minneapolis Heart Institute Foundation
Heart rhythm : the official journal of the Heart Rhythm Society | Year: 2013

Commotio cordis events due to precordial blows triggering ventricular fibrillation are a cause of sudden death (SD) during sports and also daily activities. Despite the absence of structural cardiac abnormalities, these events have been considered predominantly fatal with low survival rates. To determine whether expected mortality rates for commotio cordis have changed over time, associated with greater public visibility. US Commotio Cordis Registry was accessed to tabulate frequency of reported SD or resuscitated cardiac arrest over 4 decades. At their commotio cordis event, 216 study patients were 0.2-51 years old (mean age 15±9 years); 95% were males. Death occurred in 156 individuals (72%), while the other 60 (28%) survived. Proportion of survivors increased steadily with concomitant decrease in fatal events. For the initial years (1970-1993), 6 of 59 cases survived (10%), while during 1994-2012, 54 of 157 (34%) survived (P = .001). The most recent 6 years, survival from commotio cordis was 31 of 53 (58%), with survivor and nonsurvivor curves ultimately crossing. Higher survival rates were associated with more prompt resuscitation (40%<3 minutes vs 5%>3 minutes; P<.001) and participation in competitive sports (39%; P<.001), but with lower rates in African Americans (1 of 24; 4%) than in whites (54 of 166; 33%; P = .004). Independent predictors of mortality were black race (P = .045) and participation in noncompetitive sports (P = .002), with an on-site automated external defibrillator use protective against SD (P = .01). Survival from commotio cordis has increased, likely owing to more rapid response times and access to defibrillation, as well as greater public awareness of this condition. Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.


Hypertrophic cardiomyopathy (HCM) is the most common cause of sudden cardiac death (SCD) in young people, including trained athletes. It is now 30 years since the introduction of implantable cardioverter-defibrillators (ICDs) to clinical cardiovascular practice and coronary artery disease, and now device therapy represents the most significant therapeutic innovation and the only definitive strategy for prolonging the life of HCM patients. ICDs have proved effective in preventing SCD in young HCM patients with appropriate intervention rates of 11% for secondary and 4% for primary prevention, despite massive left ventricular (LV) hypertrophy, LV outflow obstruction, diastolic dysfunction or microvascular ischemia. Targeting candidates for prophylactic ICD therapy can be complex, compounded by the unpredictability of the arrhythmogenic substrate, the absence of a dominant risk factor, and difficulty in assembling randomized trials. However, a single major risk factor is often sufficient to justify an ICD, although additional markers and other disease features can resolve ambiguous decision-making. Nevertheless, the absence of all risk factors does not convey absolute immunity to SCD. The current risk factor algorithm, when combined with a measure of individual physician judgment (and patient autonomy considerations), is an effective guide to identifying high-risk HCM patients. ICDs have altered the natural history of HCM for many patients and provided an opportunity to achieve many decades of productive life, and the potential for normal or near-normal longevity. Indeed, prevention of SCD has now become a new paradigm in the management of HCM.

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