Navigation Links
Children's Hospital leads projects to develop nation's first heart assist devices for young children
Date:4/3/2008

Childrens Hospital of Pittsburgh of UPMC a national leader in the use of lifesaving ventricular assist devices (VADs) for children in heart failure is part of a collaboration that recently has been awarded a $2.3 million grant from the National Institutes of Health (NIH) to develop an external heart pump designed specifically for small children.

VADs are mechanical devices that take over the pumping action of the heart and offer lifesaving support, most often acting as a bridge to keep patients alive until a donor heart becomes available for transplantation. There are VADs approved by the U.S. Food and Drug Administration (FDA) for use in adults and larger adolescents in the United States, but none are designed and approved for use in infants and toddlers.

Cardiac experts in Childrens Hospitals Heart Center currently are involved in two separate projects to develop external and implantable VADs. It is estimated that as many as 1,000 children annually may benefit from these technologies, according to Peter D. Wearden, MD, PhD, a pediatric cardiothoracic surgeon and director of Pediatric Mechanical Cardiopulmonary Support at Childrens.

Unfortunately, because this is a relatively small market, companies that make medical devices historically have not focused their attention on pediatric VADs, Dr. Wearden said. Because of this, our options for treating young children in heart failure have been extremely limited. Our hope is that these two projects will lead to the first pediatric devices being approved by the FDA for use in the United States.

Childrens and medical device manufacturer Levitronix LLC received a $2.3 million National Heart Lung and Blood Institute Small Business Innovation Research (SBIR) grant to complete development of, and to clinically test, the first external centrifugal pump designed specifically for infants and small children in heart failure.

The team currently is finalizing tests of this device in the laboratory and hopes to begin the clinical trial in the coming year. The device, known as the PediVAS (ventricular assist system), would be an external pump designed to support pediatric patients in heart failure for days to four weeks.

Dr. Wearden also is spearheading efforts to develop the first totally implantable pediatric VAD in the United States that could be used for longer periods of time than the external pump.

In the development of an implantable pediatric VAD known as PediaFlow, Childrens team is partnering with two pioneers in cardiac support, Harvey S. Borovetz, PhD, deputy director, Artificial Organs and Medical Devices, McGowan Institute for Regenerative Medicine, and chair, Department of Bioengineering, University of Pittsburgh; and James Antaki, professor, Department of Biomedical Engineering, Carnegie Mellon University.

Industry partners in the consortium include Launch Point Technologies (Santa Barbara, Calif.) and WorldHeart Corporation (Salt Lake City).

This project, also funded by the NIH (one of only five centers in the nation to receive NIH funding for such a project), has progressed through an intensive engineering design phase to successful testing in the laboratory. The consortium is entering the final year of the five-year NIH contract to develop the PediaFlow.

Our dream for the PediaFlow which is about the size of a walnut is that it could be totally implanted into a child to support his or her heart until a donor could be located or until the heart function recovers, Dr. Wearden said. The PediaFlow would be magnetically powered and potentially could support a child for as long as six months.

Under the leadership of Victor Morell, MD, chief of Childrens Division of Cardiothoracic Surgery, Childrens Heart Center has established itself as one of the most active and innovative centers in the care of children in heart failure in the country over the last two decades. Childrens has performed more than 300 heart, heart-lung, lung and heart-liver transplants in children, including more than 200 heart transplants.

Childrens is one of the worlds most experienced centers in the use of VADs to support pediatric transplant patients awaiting donor hearts.

Until such time as a pediatric VAD is developed and approved for use, Childrens is one of several hospitals in the United States to have asked for and been granted, on a case-by-case basis, approval from the FDA to implant the Berlin Heart Excor for compassionate use. Five patients at Childrens have received Berlin Heart Excor devices and gone on to receive successful heart transplants. This VAD, developed in Germany, is an external pump that can be used in small children.

Weve been successful in using the Berlin Heart pump to keep young patients alive and healthy long enough for a donor heart to become available for transplant, and we are able to use adult pumps in our larger pediatric patients, Dr. Morell said. But getting approval to use a Berlin Heart can be a complicated process, especially when a young childs survival is dependent on it. This funding from the NIH for these projects is so crucial to our efforts to develop a pediatric VAD for use here in the United States as additional options for the hundreds of kids who suffer heart failure each year.


'/>"/>

Contact: Marc Lukasiak
marc.lukasiak@chp.edu
412-692-7919
Children's Hospital of Pittsburgh
Source:Eurekalert

Related biology news :

1. Clinical trial that may help patients breathe easier begins at Central DuPage Hospital
2. MRSA in hospital intensive care -- whats growing where?
3. Texas Hospital nations first to use large-scale cocoon strategy against whooping cough
4. Pennsylvania Hospital recognized for excellence in bariatric surgery
5. Childrens Hospital neurosurgeon receives grant
6. Pennsylvania Hospital surgeon receives grant to develop molecular cardiac surgery
7. Childrens Hospital studying drug with the potential to prevent/delay onset of type 1 diabetes
8. Nationwide Childrens Hospital involved in expanded access program for treatment of PKU
9. 3 out of 4 hospital patients suffer from malnutrition regardless of their pathology
10. Seattle Childrens Hospital leads $23.7 million NIH grant to study gene repair
11. Study finds environmental tests help predict hospital-acquired Legionnaires disease risk
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/20/2016)... 20, 2016  VoiceIt is excited to announce ... By working together, VoiceIt and VoicePass ... and VoicePass take slightly different approaches to voice ... security and usability. ... new partnership. "This marketing and technology ...
(Date:5/9/2016)... 9, 2016 Elevay is currently ... expanding freedom for high net worth professionals seeking travel ... globally connected world, there is still no substitute for ... duplicate sealing your deal with a firm handshake. This ... taking advantage of citizenship via investment programs like those ...
(Date:4/28/2016)... GOTHENBURG, Sweden , April 28, 2016 ... 1,491.2 M (139.9), up 966% compared with the first quarter of ... Operating profit totaled SEK 589.1 M (loss: 18.8) and the operating ... SEK 7.12 (loss: 0.32) Cash flow from operations was ... , The 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Regular discussions on a ... take place between the two entities said Poloz. ... Ottawa , he pointed to the country,s ... the federal government. ... said, "Both institutions have common economic goals, why not sit ...
(Date:6/23/2016)... , ... June 23, 2016 , ... ... release of its second eBook, “Clinical Trials Patient Recruitment and Retention Tips.” Partnering ... retention in this eBook by providing practical tips, tools, and strategies for clinical ...
(Date:6/23/2016)... Md. , June 23, 2016 A person ... from the crime scene to track the criminal down. ... the U.S. Food and Drug Administration (FDA) uses DNA evidence ... Sound far-fetched? It,s not. The FDA ... sequencing to support investigations of foodborne illnesses. Put as simply ...
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge ... envision new ways to harness living systems and biotechnology, ... Art (MoMA) in New York City ... 130 participating students, showcased projects at MoMA,s Celeste Bartos ... Paola Antonelli , MoMA,s senior curator of architecture and ...
Breaking Biology Technology: