|By PR Newswire||
|September 10, 2013 02:02 AM EDT||
NATICK, Massachusetts, September 10, 2013 /PRNewswire/ --
Unlike Medications Alone, Bronchial Thermoplasty Provides Benefits That Last for Years Rather Than Hours
A breakthrough Boston Scientific technology for the treatment of severe asthma has been shown to be safe and effective over at least five years, according to data published online in a key medical journal.
The Journal of Allergy and Clinical Immunology, the official scientific journal of the American Academy of Allergy, Asthma & Immunology (AAAAI) and the most-cited journal in the field of allergy and clinical immunology, featured data from the Asthma Intervention Research 2 (AIR2) clinical trial examining the safety and effectiveness of the Boston Scientific Alair® Bronchial Thermoplasty (BT) System. The long-term data are based on a post-approval study of BT-treated patients from the AIR2 Trial who were followed for a total of five years.
Key findings reported at five years following BT include:
- Reduction in the percentage of BT-treated patients experiencing severe exacerbations (compared to patients treated with a sham control) was maintained out to five years
- Over five years, 48 percent average decrease observed in the rate of severe exacerbations in BT-treated patients compared to the year prior to receiving BT
- Over five years, 88 percent average decrease observed in the rate of emergency room (ER) visits for respiratory symptoms in BT-treated patients compared to the year prior to receiving BT
- Comparison of high resolution computed tomography (HRCT) images before BT and at five years post BT-treatment showed no structural changes in the airways due to BT that were of clinical significance
- No increase in hospitalizations for respiratory symptoms over the course of five years
- No increase in respiratory adverse events over the course of five years
- No difference in the percentage of patients experiencing severe exacerbations, ER visits and asthma symptoms over five years based on patient reported allergy status
- 85 percent of patients who underwent BT treatment in the AIR2 Trial completed the five-year follow-up, demonstrating exceptionally strong patient retention for a study of this complexity and duration
"BT is a major innovation in the treatment of severe asthma," said Michael E. Wechsler, M.D., director of the Asthma Program in the Department of Medicine at National Jewish Health in Denver, an investigator in the AIR2 Trial, and lead author in the publication. "The compelling data from this long-term follow-up now confirm persistence of effect for BT out to at least five years."
Bronchial Thermoplasty, delivered by the Alair System, is a safe procedure. The Alair System delivers thermal energy to the airway wall in a precisely controlled manner to reduce excessive airway smooth muscle. It is designed to decrease the ability of the airway to constrict, thereby reducing frequency and severity of asthma attacks. Fewer asthma attacks means less need for the associated oral steroid treatment-and the related side effects.
"Despite great advances over the past few decades in asthma medications, many patients with severe asthma still can't get their disease under control and often have few treatment options other than oral steroids," said Mike Tringale, vice president of external affairs at the Asthma and Allergy Foundation of America (http://www.AAFA.org). "The potential to provide a long-term reduction in emergency room visits, asthma attacks and their associated need for oral steroid treatment is very important to patients with asthma."
Unlike other currently available therapies for severe asthma that have a short-term effect, a single BT treatment comprising three procedures provides long-term benefit and may lead to long-term savings for that patient, as demonstrated by the sustained reduction in asthma attacks and ER visits out to at least five years.
"There is no other treatment that I have for severe asthma patients that can give you these kinds of long-term benefits," said Mario Castro, M.D., professor of medicine and pediatrics at the Washington University School of Medicine, and principal investigator in the AIR2 Trial. "We have now completed five years of follow-up in three randomized controlled studies. In particular, this long-term study provides the clinical evidence of long-term safety and effectiveness that the asthma community has been looking for and I strongly believe that patients with severe asthma should have access to this therapy now."
The long-term benefits of Bronchial Thermoplasty, including a reduction in severe exacerbations and emergency room visits, are consistent with the stated goals of asthma control as defined by the National Asthma Education and Prevention Program (NAEPP).
To learn more about Bronchial Thermoplasty, visit http://www.BTforAsthma.com.
Asthma is one of the most common and costly diseases in the world. The prevalence of asthma has grown in recent decades, and there is no cure. According to the Asthma and Allergy Foundation of America, more than 20 million Americans have asthma. Managing asthma consumes more than $18 billion of healthcare resources each year in the United States. Uncontrolled asthma results in approximately 10 million unscheduled physician office visits, 2 million ER visits, 500,000 hospitalizations, and 4,000 deaths annually in the U.S. Five to 10 percent of those suffering from asthma in the U.S. are diagnosed with severe persistent asthma.
To view the multimedia assets associated with this release, please click:
About Boston Scientific
Boston Scientific Corporation (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit http://www.bostonscientific.com and connect on Twitter and Facebook.
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 clinical trials, as well as product performance and impact. 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.
Big Data, cloud, analytics, contextual information, wearable tech, sensors, mobility, and WebRTC: together, these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at @ThingsExpo, Erik Perotti, Senior Manager of New Ventures on Plantronics’ Innovation team, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it m...
Feb. 25, 2017 06:00 PM EST Reads: 7,680
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
Feb. 25, 2017 05:45 PM EST Reads: 2,209
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Feb. 25, 2017 05:45 PM EST Reads: 2,930
Updating DevOps to the latest production data slows down your development cycle. Probably it is due to slow, inefficient conventional storage and associated copy data management practices. In his session at @DevOpsSummit at 20th Cloud Expo, Dhiraj Sehgal, in Product and Solution at Tintri, will talk about DevOps and cloud-focused storage to update hundreds of child VMs (different flavors) with updates from a master VM in minutes, saving hours or even days in each development cycle. He will also...
Feb. 25, 2017 05:15 PM EST Reads: 2,678
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
Feb. 25, 2017 05:00 PM EST Reads: 1,515
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
Feb. 25, 2017 05:00 PM EST Reads: 2,931
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
Feb. 25, 2017 04:45 PM EST Reads: 1,734
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Feb. 25, 2017 04:30 PM EST Reads: 1,446
SYS-CON Events announced today that Addteq will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Addteq is one of the top 10 Platinum Atlassian Experts who specialize in DevOps, custom and continuous integration, automation, plugin development, and consulting for midsize and global firms. Addteq firmly believes that automation is essential for successful software releases. Addteq centers its products an...
Feb. 25, 2017 04:30 PM EST Reads: 339
In his session at @ThingsExpo, Sudarshan Krishnamurthi, a Senior Manager, Business Strategy, at Cisco Systems, will discuss how IT and operational technology (OT) work together, as opposed to being in separate siloes as once was traditional. Attendees will learn how to fully leverage the power of IoT in their organization by bringing the two sides together and bridging the communication gap. He will also look at what good leadership must entail in order to accomplish this, and how IT managers ca...
Feb. 25, 2017 04:15 PM EST Reads: 1,814
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
Feb. 25, 2017 04:15 PM EST Reads: 1,768
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Feb. 25, 2017 03:30 PM EST Reads: 2,488
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life settle...
Feb. 25, 2017 03:30 PM EST Reads: 1,585
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Feb. 25, 2017 03:15 PM EST Reads: 2,000
TechTarget storage websites are the best online information resource for news, tips and expert advice for the storage, backup and disaster recovery markets. By creating abundant, high-quality editorial content across more than 140 highly targeted technology-specific websites, TechTarget attracts and nurtures communities of technology buyers researching their companies' information technology needs. By understanding these buyers' content consumption behaviors, TechTarget creates the purchase inte...
Feb. 25, 2017 02:30 PM EST Reads: 1,740