Navigation Links
Children's Hospital leads projects to develop nation's first heart assist devices for young children

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
Children's Hospital of Pittsburgh

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:
(Date:10/26/2015)... , October 26, 2015 ... --> adds Biometrics Market ... 2021 as well as Emerging Biometrics ... reports to its collection of IT ... . --> ...
(Date:10/26/2015)... , Oct. 26, 2015  Delta ID Inc., ... authentication to mobile and PC devices, announced its ActiveIRIS® ... the arrows NX F-02H launched by NTT DOCOMO, INC ... F-02H is the second smartphone to include iris recognition ... in ARROWS NX F-04G in May 2015, world,s first ...
(Date:10/23/2015)... , October 23, 2015 ... announce a mobile plug and play integration of physiological ... tasks SensoMotoric Instruments (SMI) present a ... solutions for eye tracking and physiological data registration. It ... SMI Eye Tracking Glasses 2w and physiological signals ...
Breaking Biology News(10 mins):
(Date:11/25/2015)... 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS; TSX: ... prospects remain fundamentally strong and highlights the following ... received DSMB recommendation to continue the ZoptEC Phase ... the final interim efficacy and safety data ... men with heavily pretreated castration- and Taxane-resistant prostate ...
(Date:11/24/2015)... , Nov. 24, 2015  Asia-Pacific (APAC) holds ... organisation (CRO) market. The trend of outsourcing to ... margins but higher volume share for the region ... scale, however, margins in the CRO industry will ... Market ( ), finds that the ...
(Date:11/24/2015)... ... November 24, 2015 , ... Copper ... unless it is bound to proteins, copper is also toxic to cells. With ... Worcester Polytechnic Institute (WPI) will conduct a systematic study of copper in the ...
(Date:11/24/2015)... ... November 24, 2015 , ... This fall, global software solutions leader SAP and ... to develop and pitch their BIG ideas to improve health and wellness in their ... votes to win the title of SAP's Teen Innovator, an all-expenses paid trip to ...
Breaking Biology Technology: