|By Business Wire||
|May 22, 2014 03:00 AM EDT||
JenaValve Technology, Inc., a privately-held, venture-backed developer, manufacturer and marketer of transcatheter aortic valve implantation (TAVI) systems for the treatment of aortic valve disease, today announced the results of the JenaValve EvalUation of Long Term Performance and Safety In PaTients with SEvere AoRtic Stenosis (JUPITER) Registry at EuroPCR in Paris. JUPITER is a post-market registry designed to evaluate acute, 30-day and long-term safety and effectiveness of the 2nd generation transapical JenaValve TAVI system in elderly high-risk patients. All major VARC I events were adjudicated by an independent medical reviewer with 100 percent SAE event monitoring.
“The JUPITER registry is based on a high-risk patient population with severe degenerative aortic valve disease,” said Prof. Olaf Wendler, Consultant Cardiothoracic Surgeon at King’s College Hospital London and principal investigator for the registry. “The positive outcomes and low adverse event rates confirm the benefit of treating patients suffering from aortic stenosis with the JenaValve TAVI system.”
In the 30-day results, JenaValve demonstrated good procedural success rates and excellent clinical outcomes in a real world patient population. In 180 patients with a mean logistic EuroSCORE of 22.3 percent, the procedural success rate was 95 percent. Major adverse events such as major stroke (1.1 percent) were very low and represent the safety of the JenaValve TAVI system. Excellent hemodynamics and very low paravalvular leakage (PVL) confirm the advantages of the system; 99.4 percent of the patients were discharged with PVL that ranged from non-existent to mild, severe PVL did not occur in any of the discharged patients.
“The low PVL rates are particularly promising as post-implantation leakage around the valve is a common concern and a dangerous side effect often seen in patients with severe calcification of the valve or valve leaflets. JenaValve’s technology enables precise anatomically correct positioning and more secure attachment to even highly calcified anatomies, resulting in one of the lowest PVL rates seen in other published registry data,” Prof. Wendler added.
Prof. Dr. Hendrik Treede, M.D., Senior Consultant at the University Heart Center in Hamburg and co-investigator for the JUPITER registry, stated, “More than 25 percent of the patients included in the registry have been treated using a new proprietary delivery system called Cathlete Plus™. Cathlete Plus received CE Mark in September 2013 and we have been one of the first centers using it. The functional improvements compared to the Cathlete delivery system were obvious already in the first case: it’s intuitive and reliable design has improved the ease of use and gives you control over delivery and placement of the prosthesis. The registry confirms now that these improvements also result in outcomes even better than the legacy delivery system. The JUPITER data shows a procedural success of almost 98 percent and an all-cause mortality of 8.5 percent.”
Helmut J. Straubinger, CEO of JenaValve Technology, said, “We are very encouraged by the excellent patient outcomes and positive physician feedback related to the new Cathlete Plus delivery system. The JUPITER Registry data continue to demonstrate that the unique advantages of the JenaValve system result in beneficial clinical outcomes for patients suffering from aortic valve calcification.”
Transcatheter aortic valve implantation systems (TAVI) have already yielded nearly $1 billion in revenues worldwide and the market is expected to grow to over $3 billion in 20161. Clinicians are now focused increasingly on TAVI technical and procedural refinements and advancements found in second-generation products such as JenaValve’s, which address and resolve issues including ease of implantation, the need for post-procedure pacemaker implantation and post-implant paravalvular leakage.
About the JenaValve™ TAVI System
The JenaValve is a true second-generation catheter-based aortic valve implantation system engineered and manufactured to the highest quality standards. The JenaValve transapical TAVI system is currently being sold in Europe and other markets worldwide. The Company’s transfemoral TAVI system entered into a first-in-man clinical study at the end of 2013 and is anticipated to be commercially available for sale in 2015.
- The transapical JenaValve prosthesis consists of a natural aortic porcine root bioprosthesis fitted with an outer porcine pericardial patch, a so-called skirt, before being sewn onto a Nitinol self-expanding stent. The high-quality bioprosthesis is durable, ensuring long-term aortic valve function.
- JenaValve’s unique “3-feeler element” allows the clinician to accurately position the prosthesis in the anatomically correct position during implantation thus ensuring to achieve the correct implantation height and commissural alignment within the patient’s native valve.
- JenaClip™ anchoring and clamping mechanism allows the prosthesis to be clamped onto the patient’s native valve leaflets enabling the JenaValve to be firmly anchored in the correct anatomical position and provide active fixation and resistance to migration.
- The JenaValve implantation is conducted on the beating heart. Hemodynamic flow is maintained without cardiac arrest and rapid pacing is not required during the procedure. The low profile and the open cell design of the stent prosthesis ensure open flow to the coronaries after the implantation. The JenaValve is available in three sizes, 23mm, 25mm and 27mm, covering aortic valve annuli from 21mm to 27mm.
- JenaValve is retrievable and repositionable thereby contributing to a successful procedure and confidence of the clinician.
About JenaValve Technology
JenaValve Technology, Inc., a U.S. corporation with primary operations in Munich, Germany, develops, manufactures and markets transcatheter aortic valve implantation (TAVI) systems to treat patients suffering from aortic valve disease. JenaValve was founded in 2006 by cardiologists and inventors Prof. Hans R. Figulla, M.D. and Prof. Markus Ferrari, M.D. The Company’s transapical TAVI system is CE marked and currently marketed in Europe and other markets worldwide. JenaValve is backed by world-class U.S., European and Asian investors. Additional information is available at www.jenavalve.com.
1) Goldman Sachs Global Investment Research
SYS-CON Events announced today that Interface Masters Technologies, a leader in Network Visibility and Uptime Solutions, 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. Interface Masters Technologies is a leading vendor in the network monitoring and high speed networking markets. Based in the heart of Silicon Valley, Interface Masters' expertise lies in Gigabit, 10 Gigabit and 40 Gigabit Eth...
Oct. 26, 2016 06:45 AM EDT Reads: 3,382
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Oct. 26, 2016 06:15 AM EDT Reads: 2,069
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Oct. 26, 2016 06:00 AM EDT Reads: 1,870
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. In this power panel at @...
Oct. 26, 2016 06:00 AM EDT Reads: 2,038
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and microservices. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your conta...
Oct. 26, 2016 06:00 AM EDT Reads: 1,544
If you had a chance to enter on the ground level of the largest e-commerce market in the world – would you? China is the world’s most populated country with the second largest economy and the world’s fastest growing market. It is estimated that by 2018 the Chinese market will be reaching over $30 billion in gaming revenue alone. Admittedly for a foreign company, doing business in China can be challenging. Often changing laws, administrative regulations and the often inscrutable Chinese Interne...
Oct. 26, 2016 06:00 AM EDT Reads: 1,405
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
Oct. 26, 2016 05:45 AM EDT Reads: 2,555
SYS-CON Events announced today that Streamlyzer 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. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
Oct. 26, 2016 05:30 AM EDT Reads: 1,040
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Oct. 26, 2016 05:30 AM EDT Reads: 1,019
SYS-CON Events announced today that Pulzze Systems 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. Pulzze Systems, Inc. provides infrastructure products for the Internet of Things to enable any connected device and system to carry out matched operations without programming. For more information, visit http://www.pulzzesystems.com.
Oct. 26, 2016 05:00 AM EDT Reads: 2,578
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 26, 2016 05:00 AM EDT Reads: 997
Today every business relies on software to drive the innovation necessary for a competitive edge in the Application Economy. This is why collaboration between development and operations, or DevOps, has become IT’s number one priority. Whether you are in Dev or Ops, understanding how to implement a DevOps strategy can deliver faster development cycles, improved software quality, reduced deployment times and overall better experiences for your customers.
Oct. 26, 2016 04:45 AM EDT Reads: 946
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...
Oct. 26, 2016 04:30 AM EDT Reads: 1,193
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Oct. 26, 2016 04:30 AM EDT Reads: 1,759
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Oct. 26, 2016 04:15 AM EDT Reads: 1,171