SYS-CON MEDIA Authors: Roger Strukhoff, Pat Romanski, Elizabeth White, Glenn Rossman, Cynthia Dunlop

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
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Ope...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an In...
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud...
In her General Session at 15th Cloud Expo, Anne Plese, Senior Consultant, Cloud Product Marketing, at Verizon Enterprise, will focus on finding the right mix of renting vs. buying Oracle capacity to scale to meet business demands, and offer validated Oracle database TCO models for Oracle development and testing environments. Anne Plese is a marketing and technology enthusiast/realist with over 19...
StackIQ offers a comprehensive software suite that automates the deployment, provisioning, and management of Big Infrastructure. With StackIQ’s software, you can spin up fully configured big data clusters, quickly and consistently — from bare-metal up to the applications layer — and manage them efficiently. Our software’s modular architecture allows customers to integrate nearly any application wi...
As Platform as a Service (PaaS) matures as a category, developers should have the ability to use the programming language of their choice to build applications and have access to a wide array of services. Bluemix is IBM's open cloud development platform that enables users to easily build cloud-based, creative mobile and web applications without having to spend large amounts of time and resources o...
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will nee...
When you set off to build an app that will change the world, designing your system architecture to be reliable and scalable is important but the stark reality is that, for your MVP, you probably had a “need for speed” (of development). You didn’t know what all the axes were to scale your application, where your stress points would be, and what weird and wonderful ways your customers would use it d...
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do to...
SYS-CON Events announced today that Red Hat, the world's leading provider of open source solutions, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Red Hat is the world's leading provider of open source software solutions, using a community-powered approach to reliable and high-performing cloud, Linux, ...