|By PR Newswire||
|April 14, 2014 10:30 AM EDT||
ANDOVER, Mass., April 14, 2014 /PRNewswire/ -- The PROCEED II heart transplant Food and Drug Administration (FDA) pivotal trial results using the Organ Care System (OCS™) –Heart platform were announced on Saturday, April 12, 2014 at the International Society for Heart and Lung Transplantation (ISHLT) 34th Annual Meeting and Scientific Sessions in San Diego, Calif.
The OCS Heart PROCEED II FDA pivotal trial met its success criteria for both the primary effectiveness and safety endpoints by demonstrating that the OCS is as safe and effective as the current standard of care (SOC) in preserving standard donor hearts for transplantation. These results were achieved despite the OCS arm having significantly longer total cross clamp time as compared to SOC. In addition, the data from PROCEED II Trial demonstrated that circulating lactate level of the OCS perfusion could be a useful parameter to evaluate donor hearts status ex-vivo.
The trial data has been submitted to the U.S. FDA as part of a pre-market notification and is currently under review by the agency.
"The successful completion of our OCS Heart PROCEED II Trial and the filing of our FDA marketing application is an important milestone for TransMedics. This large international trial could be the defining work towards establishing ex-vivo heart perfusion as a viable clinical option for donor heart preservation for transplantation to overcome the challenges of cold ischemic storage," said Dr. Waleed Hassanein, President and CEO of TransMedics, Inc.
What is the TransMedics Organ Care System (OCS)?
Since the advent of organ transplantation, the cornerstone of organ preservation has been cold ischemic storage (essentially placing organs on ice). Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs. The longer the organ is kept on ice, the greater the damage. Moreover, the cold storage technique does not enable any optimization or monitoring while the organ is being transported from donor to recipient. Partly because of the limitations of cold storage, it is estimated that globally 70% to 80% of donor hearts cannot ultimately be used for transplantation.
TransMedics has developed the world's only portable medical device capable of overcoming the limitations of cold storage for organ transplantation. The OCS technology was designed to provide a comprehensive solution to all three key limitations of the cold storage technique. The OCS:
- Minimizes cold ischemia injury by perfusing the organ with a blood based perfusate
- Optimizes the condition of the organ by replenishing oxygen, nutrients, and hormones that would otherwise become depleted;
- Provides continuous monitoring and assessment of the organ until the point of transplantation
These unique capabilities of the OCS technology have the potential to:
- Improve patient survival
- Reduce post-transplant complications
- Increase utilization of current donor organs
- Improve cost-effectiveness of the transplant procedure
About PROCEED II Heart Trial
PROCEED II Trial is a large international, multi-center, clinical trial designed to evaluate the ability of the OCS Heart Technology to preserve donor hearts compared with cold storage. For more information, please visit www.clinicaltrials.gov.
About TransMedics, Inc.
TransMedics is a privately held medical technology company dedicated to extending the life saving benefits of organ transplantation to patients suffering from end-stage organ failure. Headquartered in Andover, Massachusetts, the company was founded in 1998 to address the unmet need for more and better organs for transplantation. For more information, please visit www.TransMedics.com.
SOURCE TransMedics, Inc.
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, will discuss how VPaaS enables you to move fast, creating scalable video experiences that reach your...
Sep. 27, 2016 12:00 PM EDT Reads: 1,047
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Sep. 27, 2016 12:00 PM EDT Reads: 2,548
"We have several customers now running private clouds. They're not as large as they should be but it's getting there. The adoption challenge has been pretty simple. Look at the world today of virtualization vs cloud," stated Nara Rajagopalan, CEO of Accelerite, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Sep. 27, 2016 12:00 PM EDT Reads: 2,312
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Sep. 27, 2016 12:00 PM EDT Reads: 3,823
SYS-CON Events announced today that China Unicom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE F...
Sep. 27, 2016 12:00 PM EDT Reads: 1,773
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 sett...
Sep. 27, 2016 12:00 PM EDT Reads: 3,470
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Sep. 27, 2016 11:45 AM EDT Reads: 2,699
Is your aging software platform suffering from technical debt while the market changes and demands new solutions at a faster clip? It’s a bold move, but you might consider walking away from your core platform and starting fresh. ReadyTalk did exactly that. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue and over a decade of audio conferencing product development to start an innovati...
Sep. 27, 2016 11:45 AM EDT Reads: 1,894
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
Sep. 27, 2016 11:34 AM EDT Reads: 109
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Sep. 27, 2016 11:30 AM EDT Reads: 2,968
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Sep. 27, 2016 11:15 AM EDT Reads: 952
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management solutions, helping companies worldwide activate their data to drive more value and business insight and to transform moder...
Sep. 27, 2016 11:00 AM EDT Reads: 2,693
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
Sep. 27, 2016 11:00 AM EDT Reads: 1,593
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Sep. 27, 2016 11:00 AM EDT Reads: 1,629
I’m going to cry tonight, long and hard. I’ll do so as I remember and mourn Jeremy Geelan. I knew Jeremy for almost 20 years, from the time he showed up one day at Cloud Expo’s headquarters in Bergen County, New Jersey, and went to work. The show wasn’t called Cloud Expo then, of course – it was still known as Java Edge, a pioneering event that grabbed developers, architects, and enterprise IT users alike for twice-yearly confabs. Jeremy didn’t have a job there, or even a job offer. He was s...
Sep. 27, 2016 11:00 AM EDT Reads: 3,748