Welcome!

News Feed Item

New Smaller SynCardia Total Artificial Heart Will Expand Life-Saving Therapy to All Adults & Many Adolescents

Once Results of Studies Are Approved by the FDA, the Smaller 50cc SynCardia Heart and New Permanent Use Indication Will Triple the Number of Heart Failure Patients Who Can Get a 2nd Chance at Life

TUCSON, Ariz., March 11, 2014 /PRNewswire/ -- Recent developments surrounding the SynCardia temporary Total Artificial Heart will make the life-saving device available to three times the number of people suffering from end-stage biventricular heart failure. Over 300 SynCardia Hearts have been implanted worldwide since 2012.

The 70cc SynCardia Total Artificial Heart, left, has been implanted in nearly 1,300 patients worldwide. The smaller 50cc SynCardia Heart, right, which could go to clinical trials this year pending FDA approval, is designed to fit in heart failure patients of smaller stature, including most women and many adolescents.

Clinical trials awaiting FDA approval will document the use of a new smaller 50cc version of the SynCardia Total Artificial Heart, making it available to people of smaller size, including most women, men and many adolescents.

The current 70cc SynCardia Total Artificial Heart, the world's first and only FDA, Health Canada and CE approved Total Artificial Heart, is approved as a bridge to transplant. It has been implanted in nearly 1,300 people worldwide.

See the "Arizona Illustrated" segment on SynCardia Total Artificial Heart developments.

Once approved by the FDA, the studies are expected to launch later this year. They will also investigate using the SynCardia Heart for permanent use (also known as destination therapy). This allows patients who do not qualify for a donor heart transplant — because of other health conditions or age — to receive a SynCardia Heart.

About 3,800 people wait for a heart transplant on any given day, according to the U.S. Department of Health & Human Services. The need for donor hearts is increasing, however. For over 20 years, the supply of approximately 2,300 donor hearts annually has been flat in the U.S. and the supply has generally been declining in Europe. Approximately 16% of people on the heart transplant list become too ill or die each year.

Many patients have lived with the SynCardia Heart for months or years while waiting for a matching donor heart. The longest a patient has lived with a SynCardia Heart was nearly four years before receiving a successful donor heart transplant. The SynCardia Total Artificial Heart is one of the most reliable approved heart devices. The valves in the heart have never failed and the diaphragms that pump the blood have a failure rate of less than 1% for nearly 1,300 implanted hearts, accounting for 2,600 ventricles.

Once the clinical trials are underway, both the 50cc and 70cc SynCardia Total Artificial Heart will be available as both destination therapy and bridge to transplant at study sites. The 70cc SynCardia Heart as a bridge to transplant is available at all SynCardia Certified Centers. Like a human heart transplant, the SynCardia Heart eliminates the symptoms and source of end-stage biventricular heart failure, when the left and right ventricles can no longer pump enough blood for the patient to survive.

SynCardia CEO and President Michael P. Garippa and Chief Technology Officer Rich Smith detailed these developments in a March 4, 2014 segment of "AZ Illustrated Science," a Tucson Arizona news and public affairs show that airs on Public Broadcasting. They also provided an update about the Freedom® portable driver, which powers the SynCardia Heart.

The Freedom® portable driver, at only 13.5 pounds, provides patients with almost unlimited mobility. It is pending FDA approval and is approved by Health Canada and the CE Mark for Europe. A majority of clinically stable patients are discharged with the Freedom portable driver to recover at home and in their communities. At home, patients are able to sleep in their own beds, eat out, socialize and be part of their communities. Most patients exercise, helping them become stronger for their donor heart transplant.

"Freedom patients have proven that many activities and daily living are possible, including activities that we don't necessarily endorse," Garippa says of some patients. "We've had people go four-wheeling. We've had people doing tai chi. We've had people cycle, run, take driving vacations through many states and countries and do everything but swim."

The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.

CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

About the SynCardia temporary Total Artificial Heart

For additional information, please visit: http://www.syncardia.com/
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

Photo - http://photos.prnewswire.com/prnh/20140311/LA81296

SOURCE SynCardia Systems, Inc.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud. Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
"We've discovered that after shows 80% if leads that people get, 80% of the conversations end up on the show floor, meaning people forget about it, people forget who they talk to, people forget that there are actual business opportunities to be had here so we try to help out and keep the conversations going," explained Jeff Mesnik, Founder and President of ContentMX, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
"When you think about the data center today, there's constant evolution, The evolution of the data center and the needs of the consumer of technology change, and they change constantly," stated Matt Kalmenson, VP of Sales, Service and Cloud Providers at Veeam Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
As companies gain momentum, the need to maintain high quality products can outstrip their development team’s bandwidth for QA. Building out a large QA team (whether in-house or outsourced) can slow down development and significantly increases costs. This eBook takes QA profiles from 5 companies who successfully scaled up production without building a large QA team and includes: What to consider when choosing CI/CD tools How culture and communication can make or break implementation
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Redis is not only the fastest database, but it is the most popular among the new wave of databases running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 19th Cloud Expo, Dave Nielsen, Developer Advocate, Redis Labs, will share the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
"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.
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.