Arnall Golden Gregory Adds International Business, Food and Drug Practices to D.C. Office
ATLANTA and WASHINGTON, July 21, 2011, 2011 /PRNewswire/ — Arnall Golden Gregory’s Washington office, which opened in January with a focus on privacy law, has expanded its scope to strengthen the firm’s International Business and Food and Drug practices.
Joining Atlanta-based AGG in the nation’s capital are Partners Michael E. Burke and P. Terrence Gaffney and Of Counsel Gene Burd.
Mr. Burke’s practice focuses on structuring cross-border transactions and advising clients on U.S. export controls and the Foreign Corrupt Practices Act. Mr. Burke also is involved in venture capital and private equity financing and private company M&A. He is an editor of the Thomson/West book “Corporate Counsel’s Guide to Doing Business in China,” and is Chair-Elect of the American Bar Association Section of International Law. Mr. Burke had chaired the Asia & Pacific Team at Williams Mullen.
Mr. Burd has been advising companies on conducting business in the former Soviet Union for nearly 15 years, and also represents foreign companies in the U.S. The majority of his work involves international dispute resolution. Mr. Burd served as Managing Director of the Marks, Sokolov & Burd Ukrainian office. He is Co-Chair-Elect of the Russia/Eurasia Law Committee of the ABA Section of International Law.
Mr. Gaffney has more than 20 years experience representing clients before the FDA, the FTC, Congress and other government agencies. He will be working closely with Alan G. Minsk, leader of AGG’s Food and Drug Team, and William H. Kitchens, Partner in the Healthcare/Life Sciences Group. Mr. Gaffney formerly was an attorney at SmithKline Beecham and a critical care nurse at a large teaching hospital.
“We’re delighted to bring these quality lawyers on board,” Managing Partner Glenn P. Hendrix said. “They enhance two of our core practice areas — Life Sciences and International Business.”
The D.C. office is led by Privacy Partner Robert R. Belair. Working with Mr. Belair on privacy matters are Partners Kevin Coy and Montserrat C. Miller, and Associate Kim Phan. America’s dean of privacy attorneys, Alan F. Westin, Columbia University professor emeritus, is a senior policy advisor.
Arnall Golden Gregory LLP is a mid-size law firm in Atlanta and Washington, D.C., that serves the business needs of growing public and private companies. Through mergers and acquisitions, capital markets financing, strategic alliances, joint ventures, regulatory compliance, litigation and other business-related guidance, the firm helps clients across a broad range of industries turn legal challenges into business opportunities.
Contact: Kevin Duffy404-873-8131 Kevin.duffy@agg.com
Category : Press Releases
FDA to make enforcement and compliance activities accessible online
The U.S. Food and Drug Administration today announced that it is disclosing more information about inspections and court actions, and now has a web portal1 on its enforcement activities as part of Phase II of the agency’s Transparency Initiative. These actions are being taken to make FDA’s enforcement and compliance-related activities more accessible, downloadable, and searchable online.
The information includes a summary of the most common Inspectional Observations of objectionable conditions or practices made during inspections and a searchable Inspections Database that includes the names and addresses of inspected facilities, inspection dates, type of FDA-regulated products involved, and final inspectional classification.
By the end of 2011, FDA will also begin to disclose additional information about FDA evaluations of filers, expand disclosure of Untitled Letters, and in appropriate situations, support industry efforts during a food recall to inform consumers of products that are not subject to the recall.
Access to this information about FDA’s enforcement and compliance activities will provide the following to the public and regulated industry:
* More information about company practices that may jeopardize public health, as well as about companies that have had satisfactory FDA inspections
* Information about recall and enforcement activities that will help consumers make decisions about products
* Information about inspection results, which can be expected to create a greater incentive to bring practices into compliance with the law
* Information about food products that are not subject to a particular recall, which can help reduce consumer confusion.
FDA Commissioner Margaret A. Hamburg M.D. launched FDA’s Transparency Initiative in June 2009 in response to the Obama administration’s commitment to openness in government. After holding public meetings and inviting written comments, FDA issued a report proposing 21 actions to increase disclosures about agency activities. The actions announced today stem directly from that effort and are among the first of the proposals to be implemented.
Category : Press Releases
ALTITUDE Clinical Data Show ICD Therapy Saves Lives Without Mortality Increase from Device Shock
ALTITUDE Clinical Data Show ICD Therapy Saves Lives Without Mortality Increase from Device Shock
NATICK, Mass. and SAN FRANCISCO, May 5, 2011 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of its ALTITUDE® Clinical Science program, which demonstrated that defibrillator therapy saves lives from lethal arrhythmias without an increase in mortality due to defibrillator shock. Instead, the authors found that increased mortality risk associated with these shocks is not attributed to the defibrillator shock itself, but rather entirely related to the underlying medical condition leading to atrial and ventricular arrhythmias.
ALTITUDE analyzes outcomes data from patients monitored by the LATITUDE® Patient Management system. Brian Powell, M.D., Assistant Professor of Medicine at the Mayo Clinic, presented results during a late-breaking trial session at the Heart Rhythm Society Scientific Sessions in San Francisco.
“The ALTITUDE Clinical Science program continues to provide groundbreaking data on survival after device implantation and has greatly advanced our understanding of the natural history of arrhythmias and how device programming influences patient outcomes,” said Leslie Saxon, M.D., Chief of Cardiovascular Medicine at University of Southern California and chairperson of the ALTITUDE physician panel. “What these data tell us is that patients who have atrial fibrillation or ventricular arrhythmias and receive shocks should be monitored and treated aggressively. While shocks should only be delivered when necessary, it is encouraging to know that shock therapy from these devices does not increase mortality.”
The ALTITUDE program enhances physician understanding of device therapy, outcomes and disease progression in a real-world setting for device patients followed by the LATITUDE® Patient Management system. The system lets physicians conduct remote follow-up of implantable cardiac device patients to monitor specific device information and heart health status. The system also detects clinical events between scheduled in-clinic visits and sends relevant data directly to physicians. Since its introduction in 2006, Boston Scientific has enrolled more than 190,000 patients.
Boston Scientific’s latest implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) feature AcuShock™, an advanced technology that can distinguish between a potentially lethal heart arrhythmia and a non-lethal arrhythmia within seconds, which can help to minimize inappropriate and unnecessary shocks.
“Our devices deliver painless pacing therapy far more than shocks to treat potentially lethal arrhythmias, while demonstrating extremely low rates of inappropriate shocks,” said Kenneth Stein, M.D., Chief Medical Officer, Cardiac Rhythm Management for Boston Scientific. “Recent data from a large number of patients from our ALTITUDE program show that nearly 98 percent were free of an inappropriate first shock within the first year of therapy when physicians chose to use AcuShock features in our COGNIS® and TELIGEN® devices.”
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding new product launches and launch cadence, regulatory approvals, clinical trials, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACT:
Erik Kopp
508-650-8660 (office)
Media Relations
Boston Scientific Corporation
erik.kopp@bsci.com
Sean Wirtjes
508-652-5305 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com
SOURCE Boston Scientific Corporation
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Category : Press Releases
Xlumena Receives CE Mark for Revolutionary AXIOS™ Stent and Delivery System
Xlumena Receives CE Mark for Revolutionary AXIOS™ Stent and Delivery System
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- Xlumena’s newest innovation is the first stent approved for endoscopic translumenal drainage
-A targeted commercial launch is underway in select European markets
MOUNTAIN VIEW, Calif., May 5, 2011 /PRNewswire/ — Xlumena, Inc., a privately-held provider of innovative technology for the interventional endoscopist and endoscopic surgeon, announced today that it has received CE Mark approval for its revolutionary AXIOS™ Stent and Delivery System (AXIOS). The AXIOS is the first stent designed for endoscopic ultrasound-guided translumenal therapy and is indicated for drainage of pancreatic pseudocysts. Having achieved this important milestone, Xlumena will begin a targeted commercial launch of the AXIOS in select European markets.
“The AXIOS Stent opens up a frontier of new treatments in and around the gastrointestinal tract. Not only does the AXIOS Stent create a large, secure drainage pathway – equivalent to a surgical anastomosis – it also provides an access port to pass the endoscope into the duct or lumen cavity for targeted therapy. This technology has the potential to expand the role of endoscopy in treating a variety of disorders of the pancreatic and biliary system,” stated Kenneth Binmoeller, MD, Director of Interventional Endoscopy Services at California Pacific Medical Center in San Francisco, California.
Unlike tubular stents used for bile and pancreatic duct drainage, the AXIOS Stent is designed to hold two lumens in apposition for translumenal drainage. The bilateral anchors of the AXIOS Stent prevent movement and migration and the large-diameter Stent lumen ensures drainage. The AXIOS is fully covered to prevent leakage across the stent and tissue ingrowth and facilitate removal. The AXIOS Stent comes pre-loaded in a specially-designed Delivery System and is easily deployed by a single operator.
“AXIOS leverages the expertise and vision of the interventional endoscopy community. It represents a new frontier in endoscopic therapy that uses ultrasound to guide intervention outside of the gastrointestinal tract. This avoids more invasive treatments such as surgery,” commented Michael Allen, Xlumena’s President and CEO. “Xlumena is committed to advancing endoscopic treatment options through the development of safe, efficient and easy to use technologies.”
About the AXIOS Stent and Delivery System
The AXIOS Stent is fully-covered, self-expandable and available in multiple lumen diameters (15mm, 10mm, 8mm and 6mm) and lengths (10mm, 6mm and 4mm) to ensure a custom fit. The Delivery System is ergonomic and allows the interventional endoscopist to control and precisely deliver the AXIOS to the intended target using a single hand. To view an animation of the AXIOS Stent and Delivery System, visit http://www.vimeo.com/xlumena/axios
About Xlumena
Xlumena is the leader in the development of image-guided therapeutic endoscopy products, specializing in advanced implants and devices for a new, rapidly growing field of medicine. Collaborating with top physicians in the field, Xlumena focuses on technologies that advance therapy to the next level. These innovations may enable numerous translumenal therapeutic procedures, helping transform complex surgeries into outpatient events.
To view an animation of Xlumena’s first product, the NAVIX Access Device (FDA cleared), visit http://www.vimeo.com/xlumena/navix
Contact: Witney McKiernan 650.961.9900
SOURCE Xlumena, Inc.
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Category : Press Releases
Econiche(TM) Vaccine Efficacy Challenge Study Summarized in The Canadian Journal of Veterinary Research
BELLEVILLE, ON, May 5 /PRNewswire-FirstCall/ – Bioniche Life Sciences Inc. (TSX: BNC) (ASX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today announced that the results of a controlled challenge study with the Company’s Escherichia coli (E. coli) O157 cattle vaccine -EconicheTM – have been published in this month’s issue of The Canadian Journal of Veterinary Research (2011;75:98-105), a peer-reviewed scientific journal.
The article, entitled, “Vaccination with type III secreted proteins leads to decreased shedding in calves after experimental infection with Escherichia coli O157″, was co-authored by Kevin J. Allen, Dragan Rogan, B. Brett Finlay, Andrew A. Potter, David J. Asper. This article summarized a controlled challenge study conducted in early 2008 at the Vaccine and Infectious Disease Organization (VIDO) – University of Saskatchewan which was the final study that led to the full Canadian license for EconicheTM from the Canadian Food Inspection Agency (CFIA) in October, 2008.
The controlled challenge study at VIDO involved 30 placebo-treated cows and 30 vaccinated cows. The vaccinated cows each received three doses of EconicheTM. Both groups were then infected with E. coli O157 and fecal shedding was monitored daily for a two-week period. These data indicate that EconicheTM vaccination had protective effects through significant reductions in both the number of animals shedding and the number of challenge organisms shed per animal. The authors of the article summarized the study by saying it provides evidence that vaccination with EconicheTM is an effective pre-harvest intervention strategy against E. coli O157.
These data constitute part of the Company’s international regulatory dossier in such jurisdictions as Australasia, Europe, Scandinavia, and South America. The Company has been actively exploring opportunities to introduce EconicheTM to markets beyond North America, where it has a full license (Canada) and a pending conditional license (U.S.).
EconicheTM will be manufactured in the Company’s newly completed Animal Health and Food Safety Vaccine Manufacturing Centre in Belleville, Ontario, currently undergoing validation and commissioning. Full production in the new Centre is expected to begin by the fall of 2011.
About the Bioniche E. coli O157 Vaccine (EconicheTM)
The Food Safety Division of Bioniche Life Sciences Inc. has worked with Canadian university researchers, in particular, inventor Dr. Brett Finlay and his team at the University of British Columbia, to develop and license a cattle vaccine against E. coli O157. This vaccine – trademarked EconicheTM – is meant to reduce the level of the bacterium in water, food and the environment and, in turn, reduce the potential infection of humans.
EconicheTM has the potential to significantly reduce the amount of E. coli O157 shed into the environment by beef and dairy cattle. This organism does not cause illness in cattle, but cattle are the primary reservoir for it. Vaccination of cattle with EconicheTM can help reduce the risk of food and waterborne contamination with E. coli O157.
EconicheTM has been developed by a strategic alliance formed in September, 2000 and composed of the University of British Columbia (UBC), the Alberta Research Council (ARC), the University of Saskatchewan’s Vaccine and Infectious Disease Organization (VIDO), and Bioniche, which holds the rights for worldwide commercialization of the vaccine.
More about E. coli O157
The E. coli O157 organism causes no disease in cattle, but cattle are the primary reservoir for it. E. coli O157 can cause severe illness and can even be fatal when ingested by humans from contaminated meat, vegetables, other food products, or water. Human exposure and infection with E. coli O157 can result in serious health consequences, including abdominal pain and severe bloody diarrhea. In severe cases, kidney damage can occur and progress to serious complications and even death. Lingering, long-term medical conditions can persist in individuals exposed to the bacterium. These include post-infectious irritable bowel syndrome (PI-IBS), reduced kidney function, diabetes, hypertension and reactive arthritis.
An estimated 100,000 cases of human infection with the E. coli O157 organism are reported each year in North America. Two to seven per cent of those people develop haemolytic uremic syndrome (HUS), a disease characterized by kidney failure. Five percent of HUS patients die, many of them children and senior citizens, whose kidneys are more sensitive to damage.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs more than 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
Category : Press Releases
MHPA Center for Best Practices Receives Sponsorship from Ortho-McNeil Janssen Pharmaceuticals, Inc. to Improve Medicaid Quality, Care Coordination for Serious Mental Illness
WASHINGTON, May 4, 2011 /PRNewswire-USNewswire/ — The Center for Best Practices, a new affiliate organization of Medicaid Health Plans of America (MHPA), today announced the receipt of financial sponsorship from Raritan, NJ-based pharmaceutical company Ortho-McNeil-Janssen Pharmaceuticals, Inc. to engage Medicaid managed care clinical leadership on the best ways to treat plan members with schizophrenia, bipolar disorder, and other severe mental illness (SMI). The initiative called “Best Practices to Integrate Care for Seriously Mentally Ill Beneficiaries” will begin immediately and will take a multifaceted approach to raising the level of understanding at Medicaid health plans including creating web-based educational programs and publishing resources to aid in management of SMI.
“The mission of the Center for Best Practices is to inform and educate Medicaid health plans on how best to treat the low-income population they serve, with some of the Center’s priorities falling very much in line with the goals of this effort,” said Thomas L. Johnson, MHPA’s President and CEO. “The Center’s focus on highlighting effective Medicaid health plan programs and improving care coordination and treatment adherence, especially in the area of medical and behavioral health services, dovetails well with the commitment of Ortho-McNeil-Janssen to improving the health of patients affected by these diseases. We are proud to have such a dedicated and innovative company that has done so much in the field of mental health as the Center’s first-ever sponsor.”
The Center will provide web content and resources such as data and information for effectively serving those Medicaid patients with SMI. The Center also will partner with advocacy groups representing the SMI population to better understand the issues specific to this disease. Educational webinars on topics ranging from increasing adherence to ensuring effective transitions from inpatient to outpatient care are also planned. In addition, the Center will publish a compilation of health plan best practices that details specific examples of progress in treating those with SMI. This compendium will also include statistics and other mental health resources that may be useful to Medicaid health plans.
“People with life-altering diseases such as schizophrenia or bipolar disorder often experience a number of issues including higher rates of unemployment, poverty and even homelessness,” Johnson noted. “Coordinated care to address the physical and mental health needs of this special population is needed. Given the integrated systems of care inherent in Medicaid health plans, disseminating knowledge of what works best for those with serious mental illness is a very important step in ensuring the best possible care for these patients.”
Ortho-McNeil-Janssen Pharmaceuticals, Inc. is the first pharmaceutical company sponsor for this project. The sponsorship will ultimately be expanded to include multiple pharmaceutical company sponsors, however sponsors will have no control or influence on initiatives conducted by the MPHA Center for Best Practices.
About Medicaid Health Plans of America
Medicaid Health Plans of America (MHPA) is the leading trade association solely focused on representing Medicaid health plans. MHPA provides advocacy, research and organized forums that support the development of policy solutions to enhance the delivery of quality health care. For more information, visit Medicaid Health Plans of America at http://www.mhpa.org or email at info@mhpa.org.
Category : Press Releases
Avanir Pharmaceuticals Announces Landmark ‘PRISM’ Pseudobulbar Affect Patient Registry
Registry will Assess Relationship between PBA and Quality of Life
ALISO VIEJO, Calif., May 4, 2011 /PRNewswire/ — Avanir Pharmaceuticals, Inc. (Nasdaq: AVNR) today announced the PRISM patient registry, the first patient registry to further quantify the prevalence and quality of life impact of pseudobulbar affect (PBA) in patients with a variety of underlying neurologic conditions. Nearly two million Americans with existing neurologic disease or brain injury are estimated to be living with the added burden of PBA, a condition characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or are incongruent to the patient’s underlying emotional state. Until now, the complexity of those distinct conditions has served as a barrier to widespread collaboration among treating physicians.
The PRISM registry aims to define the prevalence of PBA in patients with the associated underlying neurologic conditions of amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), Parkinson’s disease, stroke, traumatic brain injury (TBI), and Alzheimer’s disease. Avanir anticipates recruiting 10,000 patients into the registry across approximately 500 sites in the U.S. Avanir is working with Novella Clinical as the company’s contract research organization and expects enrollment to initiate in May and continue for at least six months. Data collected through PRISM will serve as the basis for continued clinical research efforts surrounding PBA.
“The PRISM registry will assess the relationship between PBA and quality of life among affected patients,” said Randall Kaye, M.D., chief medical officer of Avanir. “In addition, data collected across multiple sites in the U.S. will allow participating investigators to compare the incidence of PBA within their practice to regional and national numbers. At Avanir, we believe a better understanding of PBA prevalence is positive for physicians, patients, and caregivers alike, and are thrilled to initiate what will ultimately be the largest PBA clinical registry ever performed.”
“As a physician working directly with patients impacted by various neurological conditions and PBA, the PRISM registry represents a tremendous step forward in helping to document the true impact of this misunderstood and under-diagnosed condition,” said Jonathan Fellus, M.D., medical director of rehabilitation, Meadowlands Hospital Rehabilitation Institute in New Jersey. “For too long, patients and their families have battled involuntary, sudden, and frequent episodes of laughing and/or crying without the knowledge and comfort that this condition is a treatable condition that many other patients are living with and managing on a daily basis.”
About PBA
Patients suffering from existing neurologic disease or brain injury may also suffer the added burden of pseudobulbar affect, or PBA. PBA occurs secondary to a variety of otherwise unrelated neurologic conditions, and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying. PBA episodes typically occur out of proportion or incongruent to the patient’s underlying emotional state. PBA outbursts result from a “short circuit” in the brain caused by another neurologic condition-such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), stroke, or traumatic brain injury. PBA can have a debilitating impact on the lives of patients, caregivers and loved ones. For more information about PBA, please visit www.PBAinfo.org.
About Avanir Pharmaceuticals, Inc.
Avanir Pharmaceuticals, Inc. is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need. As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones. For more information about Avanir, please visit www.avanir.com.
About Novella Clinical
Novella Clinical, Inc. is a full service contract research organization headquartered in Research Triangle Park, N.C. For more than a decade, Novella has served as an active partner to the oncology, biopharma and medical device industries. As the first global eCRO, Novella integrates deep clinical expertise with industry-leading technologies and a proven approach to support, streamline and expertly resource the entire product development process. For more information, visit www.novellaclinical.com.
AVANIR™ is a trademark owned by Avanir Pharmaceuticals, Inc.
©2011 Avanir Pharmaceuticals, Inc. All Rights Reserved.
Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the launch of a registry study are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the ability to enroll clinical sites, the ability to enroll patients into the registry, the ability to define the prevalence of PBA, and other risks detailed from time to time in the Company’s most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
SOURCE Avanir Pharmaceuticals, Inc.
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CDISC Standards at Core of FDA Cross Study Clinical Trial Respostiory Project
Standards from the Clinical Data Interchange Standards Consortium (CDISC) were specified in a project recently awarded for development of a Clinical Trial Repository (CTR) for the U.S. Food and Drug Administration (FDA). The FDA is partnering with the National Cancer Institute Center for Biomedical Informatics and Information Technology (NCI CBIIT) to create this CTR to support automatic validation, loading and management of data from clinical trials to support comparative effectiveness research and regulatory review. A subcontract to design, develop and implement the CTR database structure and related infrastructure was awarded to Ekagra Software Technologies, who will work with FDA and NCI to fulfill the requirements of this project by 2013.
The FDA, which currently houses the largest known repository of high quality research study data on safety and efficacy of biologics, drugs and devices, has long awaited a database to support comparisons across similar products. However, this requires that data be provided in a standard format to enable rigorous analyses and comparisons. The Statement of Objectives in the solicitation for the CTR project specifies that the vendor will provide operational support for the processing of CDISC Study Data Tabulation Model (SDTM) data as well as for the incremental load and testing of legacy-converted datasets during the implementation effort. The SDTM standard was developed through a consensus-based process over the course of the last decade to support the electronic submission of clinical research data to FDA to facilitate their reviews of applications for the approval of new therapies.
In addition, the solicitation indicates that the new CTR will be compliant with appropriate standards, including the Biomedical Research Integrated Domain Group (BRIDG) Model. The BRIDG model was initiated by CDISC in 2004 and is now supported through a collaborative group that includes CDISC, Health Level Seven (HL7), NCI and FDA. It is a means of harmonizing across all of the CDISC standards that support biomedical research from protocol through analysis and reporting. The BRIDG model is now a CDISC standard, an HL7 standard and is entering its last ballot cycle to become an ISO/CEN standard through the Joint Initiative Council for global harmonization of standards.
“The FDA leadership is to be commended on their efforts to adopt standards that will improve their reviews of new applications for therapies and to develop a database to support regulatory science and cross-product analyses” stated Dr. Frank Rockhold, Chair of the CDISC Board of Directors “They are clearly striving to improve their processes for the benefit of public health.”
The request for proposals for the CTR states “the availability of this repository for organizing, and extracting scientific data about regulated products in a common “language” or format to support regulatory decision making underpins the success of any broader initiatives to comparatively evaluate product performance. Such a data repository will be developed during this project”.
For more information, please see: https://www.fbo.gov/index?s=opportunity&mode=form&id=3f9ce599bf3d89c4bdd18651d9d68ebb&tab=core&_cview=1
Read more: http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2011/05/03/prweb8373152.DTL#ixzz1LO7P5uoa
Category : Press Releases
Boston Scientific Announces CE Mark Approval and First Use of Blazer™ Open-Irrigated Catheter in Europe
Radiofrequency ablation catheter designed to treat a variety of arrhythmias
NATICK, Mass., May 3, 2011 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced CE Mark approval and first use in Europe of its Blazer™ Open-Irrigated Catheter, the Company’s latest radiofrequency ablation (RFA) catheter designed to treat a variety of arrhythmias such as atrial fibrillation, atrial flutter, ventricular tachycardia and other supraventricular tachycardias. The product is being launched this quarter in select CE Mark countries.
The Blazer Open-Irrigated Catheter integrates Total Tip Cooling™ Design with the high-performance Blazer™ Catheter platform. Total Tip Cooling Design is intended to consistently cool the entire tip electrode during radiofrequency energy delivery. This is achieved through both internal cooling and external washing of the tip electrode, which is designed to reduce coagulum at the proximal edges of the tip.
The first European procedure using the Blazer Open-Irrigated Catheter was performed at the Hopital Cardiologique du Haut–Leveque in Bordeaux–Pessac, France, under the supervision of Prof. Michel Haissaguerre, M.D.
“The excellent cooling profile, coupled with the high performance Blazer platform, makes this catheter an important additional option for performing complex ablations,” said Sebastien Knecht, M.D., Ph.D., who performed the procedure with Frederic Sacher, M.D. “The tip temperatures were lower than conventional open-irrigated catheters during RF delivery, and the bidirectional catheter performed very well, accessing the pulmonary veins with dependable steering and tip stability.”
Affecting more than 4.5 million Europeans, atrial fibrillation is an arrhythmia associated with a rapid rhythm in the upper chambers of the heart. Patients are most often treated with anti-arrhythmic drugs, which can often cause adverse side effects. Cardiac ablation with an RFA catheter is increasingly becoming an option for patients who cannot tolerate these medications.
“The CE Mark approval, first use and launch of the Blazer Open-Irrigated Catheter in Europe are important milestones in our continued focus on advancing cardiac ablation technology,” said Hank Kucheman, Executive Vice President and President of Boston Scientific’s Cardiology, Rhythm, and Vascular Group. “We are committed to expanding our European electrophysiology business and improving outcomes for patients undergoing cardiac ablation procedures.”
In the U.S., the Blazer Open-Irrigated Catheter is an investigational device, limited by applicable law to investigational use only and not available for sale.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
Category : Press Releases
Thoratec Comments on Publication of HeartMate II® Bridge-to-Transplantation Post-Approval Study in JACC
DATA SHOW SURVIVAL OF 90 PERCENT AT SIX MONTHS AND MEANINGFUL REDUCTION IN ADVERSE EVENTS
PLEASANTON, Calif., May 3, 2011 /PRNewswire/ — Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today commented on an article published in the Journal of the American College of Cardiology (JACC) examining outcomes from a bridge-to-transplantation (BTT) post-approval study featuring the company’s HeartMate II® LVAS (Left Ventricular Assist System). The article’s lead authors include Dr. Randall Starling from Cleveland Clinic, Dr. Yoshifumi Naka from Columbia Presbyterian Hospital, and Dr. Andrew Boyle from Aurora St. Luke’s Medical Center.
Results from the study showed survival for patients on HeartMate II in the commercial setting of 90 percent at six months and 85 percent at one year. Additionally, the study found meaningful improvements in important adverse event categories when compared to a similar group of patients implanted with other approved LVADs. In particular, HeartMate II patients experienced extremely low occurrences of some of the most critical adverse events, including pump replacement, stroke, and right heart failure.
The HeartMate II received FDA approval for BTT in April 2008. The post-approval study was designed to assess whether the commercial use of the HeartMate II was comparable to other available commercial devices approved for BTT and to validate the findings from the pivotal clinical trial regarding the efficacy and risk profile of the HeartMate II.
The FDA-sanctioned post-approval study compared outcomes from the first 169 post-approval HeartMate II BTT patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) in the U.S., versus 169 patients who were treated with either the HeartMate® XVE or Thoratec® IVAD™ (Implantable Ventricular Assist Device). Patients were enrolled at 77 U.S. centers and followed for at least one year after implant. The primary endpoint was survival while awaiting transplantation, with secondary endpoints including adverse events, functional status and quality of life. Enrollment of HeartMate II patients in the study occurred from April 2008 through August 2008.
For the HeartMate II patients, 62 percent were classified as INTERMACS profile I or II, representing the sickest end-stage heart failure patients, including almost 25 percent in profile I. INTERMACS profile I describes patients in critical cardiogenic shock, while INTERMACS profile II captures patients in progressive decline on inotropes.
“The results for HeartMate II in this challenging patient population are highly compelling, not only in terms of absolute survival but also with respect to quality of life and continued reductions in adverse events,” said Gary F. Burbach, president and chief executive officer of Thoratec. “In particular, we were pleased with the extremely low rates of device replacement and stroke, validating the favorable thrombotic profile and flexible patient management strategies facilitated by the device,” he added.
Key findings for the HeartMate II study population were as follows:
* Kaplan-Meier survival was 90 percent at six months and 85 percent at one year.
* 91 percent of patients achieved a successful outcome of transplant, cardiac recovery or ongoing LVAD support at six months.
* Device replacement occurred at a rate of 0.01 events per patient-year over the duration of the study. No patients required a pump replacement during the first six months of support.
* The total stroke rate was 0.08 events per patient-year.
* Only 3 percent of patients developed right heart failure requiring a right ventricular assist device.
* Rates of bleeding, infection, respiratory failure, and renal failure, among others, demonstrated meaningful improvements when compared to earlier published clinical trial results.
“The results of this post-approval study support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HeartMate II LVAD in a post-market approval ‘real world’ BTT population. The results also show encouraging improvement in outcomes with the device in commercial use since completion of the clinical trial,” the authors noted in the article. “Surprisingly, as the HeartMate II device became available outside of the controlled context of a clinical trial, excellent results were maintained or perhaps surpassed.”
“We look forward to sharing these results, which have been incorporated into the HeartMate II label, as well as the positive outcomes we are seeing with the HeartMate II for Destination Therapy patients, as part of our efforts to educate the clinical community and to foster greater appreciation for the value of mechanical circulatory support in treating advanced-stage heart failure patients,” Burbach said.
About HeartMate II
The Thoratec HeartMate II Left Ventricular Assist Device (LVAD) is a mechanical circulatory support (MCS) device intended for a broad range of advanced-stage heart failure patients. HeartMate II is designed to restore blood flow and to improve survival, functional status, and quality of life. The HeartMate II, implanted alongside a patient’s native heart, is designed to take over the pumping ability of the weakened heart’s left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. HeartMate II is the only continuous flow LVAD that is FDA approved for both bridge-to-transplantation and destination therapy, or long-term, support.
About Thoratec
Thoratec is a world leader in therapies to address advanced-stage heart failure. The company’s products include the HeartMate LVAS and Thoratec VAD, with more than 18,000 devices implanted in patients suffering from heart failure. Thoratec is headquartered in Pleasanton, California. For more information, visit the company’s web site at http://www.thoratec.com.
Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation and IVAD is a trademark of Thoratec Corporation.
Many of the preceding paragraphs, particularly but not exclusively those addressing the performance of the company’s devices in the clinical trial or commercial setting, contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, “believes,” “views,” “expects,” “plans,” “projects,” “hopes,” “could,” “will,” and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec’s control. Therefore, readers are cautioned not to put undue reliance of these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, customer and physician acceptance of Thoratec products and the effects of healthcare reimbursement and coverage policies. Forward-looking statements contained in this press release should be considered in light of these factors and those factors discussed from time to time in Thoratec’s public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, “Risk Factors,” in Thoratec’s most recent annual report on Form 10-K and as may be updated in subsequent SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.
SOURCE Thoratec Corporation
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