|By PR Newswire||
|December 17, 2012 02:00 AM EST||
MOUNTAIN VIEW, California, Dec. 17, 2012 /PRNewswire/ -- PneumRx, Inc., a leader in interventional pulmonology, announced today that University Medical Center Groningen has enrolled and treated the first patients in the FDA-approved RENEW pivotal trial to evaluate the RePneu Lung Volume Reduction Coil (LVRC). The RePneu LVRC, a minimally invasive medical implant designed to treat the symptoms of severe emphysema, is intended to improve lung function, exercise ability and quality of life for this underserved patient population.
Dr. Dirk-Jan Slebos is the principal trial investigator at UMCG. "There is no cure for severe emphysema, and patients have very few options available to relieve their symptoms," he said. "The LVRC is a very exciting technology that has shown great promise in European clinical studies. We have seen significant clinical improvements in treated patients, and we believe this is an important treatment option for many patients with severe emphysema."
The RePneu LVRC is already a proven technique in Europe, having undergone safety and effectiveness evaluation of more than 100 patients in three multi-center European clinical studies, with over 50 patients having been treated at UMCG since 2009. The technology is routinely available to treat patients in Germany, and was the only emphysema treatment method selected by the French Ministry of Health to undergo a multi-center cost-effectiveness study in France starting in early 2013. Unlike Lung Volume Reduction Surgery or other minimally invasive devices designed to treat emphysema, the RePneu LVRC is intended to treat a broad range of emphysema patients, including those with heterogeneous and homogeneous disease, in both upper and lower lobes, and it performs independently of collateral ventilation.
The results of this IDE Pivotal study will be used to support a PMA application for the RePneu LVRC, with the goal of offering the device commercially in the US as soon as possible.
Emphysema is medically characterized by reduced lung function and increased lung volume, which makes breathing very difficult. As the disease progresses and the lung's natural elastic properties are destroyed, excess air is trapped in the lungs, making it difficult for the person to exhale. This process is known as hyperinflation and is responsible for the feeling of being "short of breath."
The RePneu LVRC works by compressing the hyperinflated lung tissue to reduce volume, while helping to restore the lung's natural elastic recoil. The LVRC also helps hold open the lung's airways, preventing airway collapse that causes air trapping and hyperinflation. Implanting the LVRC involves a minimally invasive, non-surgical procedure, and most patients are able to return home the following day.
The RENEW trial is enrolling patients throughout the US and Europe who have been clinically diagnosed with severe emphysema and are experiencing increasing difficulty with simple daily tasks despite optimal medical management. Patients must be over 35 years of age, must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program within six months and/or be on a maintenance program.
This multicenter, randomized FDA clinical trial will investigate the safety and effectiveness of the RePneu LVRC compared to standard medical care alone. Up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, UK and Germany, will participate. Though RePneu LVRC is investigational in the United States and not yet approved for commercial use by the FDA, the device has been used in Europe - in clinical trials and commercially - for the treatment of severe emphysema since 2008.
For more information about the RePneu LVRC and the RENEW study, visit www.pneumrx.com or http://www.clinicaltrials.gov/ct2/show/NCT01608490?term=RENEW&rank=1.
About Advanced Emphysema
Over three million(1) Europeans suffer from advanced emphysema, a chronic, debilitating disease most commonly brought on by years of smoking. Emphysema causes irreversible damage to delicate lung tissue, leading to shortness of breath and even feelings of suffocation that result in reduced quality of life. Emphysema is medically characterized by reduced lung function, increased lung volume and loss of the lung's natural elastic properties, which makes breathing very difficult.
As the disease progresses and lung tissue is destroyed, excess air is trapped in the lungs making it difficult for the person to exhale. This process is known as hyperinflation and responsible for the feeling of being "short of breath." Patients with severe emphysema experience shortness of breath nearly all the time, even when resting, and suffer from continuous fatigue, chronic coughing, wheezing and frequent respiratory infections. Patients are also at higher risk for lung infection, inflammation and other respiratory conditions, as well as serious other systemic conditions such as diabetes(2) and heart disease(3).
As there is no cure for emphysema, the goal of current treatment methods such as drug therapy (inhaled steroids, bronchodilators and antibiotics), supplemental oxygen, and pulmonary rehabilitation (breathing exercises) is to relieve symptoms and teach people how to live with the disease. Eventually, the disease will exhaust these treatment methods, leaving the patient with very few options for symptom relief(4).
About PneumRx Inc.
PneumRx, Inc. is a Mountain View, CA based medical device start-up focused on developing minimally-invasive solutions for unmet medical needs in pulmonary medicine. The flagship product, the RePneu® Lung Volume Reduction Coil, is designed to reduce lung volume and restore elastic recoil to improve lung function, exercise capacity, and quality of life for patients with emphysema. Made from shape-memory Nitinol, the RePneu Coil compresses hyperinflated tissue and tethers small airways to prevent airway collapse without blocking or destroying lung parenchyma, a key advantage over other endoscopic techniques. The RePneu LVRC is limited to investigational use in the U.S.A. Read more at www.pneumrx.com.
(1) National Emphysema Foundation, via http://www.emphysemafoundation.org/about-us.html
(2) Emma H Baker MD and Derek Bell MD. Blood glucose: of emerging importance in COPD exacerbations. Thorax 2009;64:830-832.
(3) Kaiser Permanente Medical Care Program. COPD and Incident Cardiovascular Disease Hospitalizations and Mortality. Chest 2005: 128: 2068-075
(4) Centers for Disease Control and Prevention. Chronic Obstructive Pulmonary Disease Surveillance – United States, 1971-2000. Morbidity and Mortality Weekly Report. August 2, 2002; 51(SS06):1-16.
SYS-CON Events announced today that Enzu, a leading provider of cloud hosting solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive advantage. By offering a suite of proven hosting and management services, Enzu wants companies to foc...
May. 26, 2016 04:15 PM EDT Reads: 2,151
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 26, 2016 04:15 PM EDT Reads: 2,722
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 26, 2016 04:15 PM EDT Reads: 1,994
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
May. 26, 2016 04:15 PM EDT Reads: 345
As cloud and storage projections continue to rise, the number of organizations moving to the cloud is escalating and it is clear cloud storage is here to stay. However, is it secure? Data is the lifeblood for government entities, countries, cloud service providers and enterprises alike and losing or exposing that data can have disastrous results. There are new concepts for data storage on the horizon that will deliver secure solutions for storing and moving sensitive data around the world. ...
May. 26, 2016 04:00 PM EDT Reads: 1,202
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 26, 2016 04:00 PM EDT Reads: 2,030
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide 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 ...
May. 26, 2016 04:00 PM EDT Reads: 1,860
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
May. 26, 2016 03:45 PM EDT Reads: 2,486
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
May. 26, 2016 03:45 PM EDT Reads: 2,284
Customer experience has become a competitive differentiator for companies, and it’s imperative that brands seamlessly connect the customer journey across all platforms. With the continued explosion of IoT, join us for a look at how to build a winning digital foundation in the connected era – today and in the future. In his session at @ThingsExpo, Chris Nguyen, Group Product Marketing Manager at Adobe, will discuss how to successfully leverage mobile, rapidly deploy content, capture real-time d...
May. 26, 2016 03:45 PM EDT Reads: 1,487
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
May. 26, 2016 03:45 PM EDT Reads: 976
IoT generates lots of temporal data. But how do you unlock its value? How do you coordinate the diverse moving parts that must come together when developing your IoT product? What are the key challenges addressed by Data as a Service? How does cloud computing underlie and connect the notions of Digital and DevOps What is the impact of the API economy? What is the business imperative for Cognitive Computing? Get all these questions and hundreds more like them answered at the 18th Cloud Expo...
May. 26, 2016 03:30 PM EDT Reads: 2,187
SYS-CON Events announced today the How to Create Angular 2 Clients for the Cloud Workshop, being held June 7, 2016, in conjunction with 18th Cloud Expo | @ThingsExpo, at the Javits Center in New York, NY. Angular 2 is a complete re-write of the popular framework AngularJS. Programming in Angular 2 is greatly simplified. Now it’s a component-based well-performing framework. The immersive one-day workshop led by Yakov Fain, a Java Champion and a co-founder of the IT consultancy Farata Systems and...
May. 26, 2016 03:30 PM EDT Reads: 3,931
SYS-CON Events announced today that Isomorphic Software will exhibit at SYS-CON's [email protected] at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, high-productivity enterprise web applications for any device. SmartClient couples the industry’s broadest, deepest UI component set with a java server framework to deliver an end-...
May. 26, 2016 03:30 PM EDT Reads: 2,005
The cloud market growth today is largely in public clouds. While there is a lot of spend in IT departments in virtualization, these aren’t yet translating into a true “cloud” experience within the enterprise. What is stopping the growth of the “private cloud” market? In his general session at 18th Cloud Expo, Nara Rajagopalan, CEO of Accelerite, will explore the challenges in deploying, managing, and getting adoption for a private cloud within an enterprise. What are the key differences betwee...
May. 26, 2016 03:00 PM EDT Reads: 1,566