Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Minimally Invasive Pediatric VAD for Treatment of Acute Heart Failure

Award Number: R44HL099192
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/15/2011
PERIOD OF PERFORMANCE END DATE: 12/31/2014

Group Awards By:

View Award Description

Minimally Invasive Pediatric VAD for Treatment of Acute Heart Failure - DESCRIPTION (provided by applicant): The overall objective of this proposed program is the commercialization of the Pediatric Impella system, a minimally invasive ventricular assist device (VAD) for treatment of acute heart failure in pediatric patients. The device will be a less traumatic alternative to extracorporeal membrane oxygenation (ECMO), the current standard of care for these patients. The target patient population is in the age and weight range of 3 mos - 3 yrs and 5-15 kg. The Pediatric Impella system will be designed to unload the left ventricle and promote cardiac recovery, providing blood flow in the range of 0.5-2 lpm for up to 2 wks of support. Reviewers pointed out in discussion that the device is not as minimally invasive as claimed and will require more anticoagulation than is suggested in the application. Since there are only a few devices in the field for this problem, this proposal addresses a great unmet clinical need and has high significance. PUBLIC HEALTH RELEVANCE: It is estimated that approximately 9,000 infants born with congenital heart defects each year in the U.S. require some form of invasive intervention during the first years of life. Many of these children require mechanical circulatory support as a bridge to recovery or to transplant. Shorter duration of support (for days to at most a few weeks) for acute, generally recoverable heart failure is mostly provided by extracorporeal membrane oxygenation (ECMO). ECMO is highly invasive and is associated with a host of complications including blood clots, bleeding, ongoing heart failure, and strokes. Therefore, a strong unmet clinical need exists for a minimally invasive ventricular assist device (VAD) that can supplant ECMO for treatment of acute heart failure in pediatric patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $428,642 )
2014	2014	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	001	3	4/8/2014	NON-COMPETING CONTINUATION	$42,865
2014	2014	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	000	3	2/22/2014	NON-COMPETING CONTINUATION	$385,777
														Subtotal = $428,642

Issue Date FY: 2013 ( Subtotal = $0 )
2013	2011	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	000	2	3/8/2013	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2012 ( Subtotal = $0 )
2012	2011	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	000	2	4/23/2012	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2011 ( Subtotal = $663,647 )
2011	2011	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	002	2	1/13/2011	EXTENSION WITH OR WITHOUT FUNDS	$663,647
2011	2010	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	001	1	1/12/2011	NEW	$0
2011	2010	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	000	1	12/22/2010	NEW	$0
														Subtotal = $663,647

Issue Date FY: 2010 ( Subtotal = $199,454 )
2010	2010	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	001	1	7/23/2010	NEW	$0
2010	2010	ABIOMED, INC	33 CHERRY HILL DRIVE	DANVERS	MA	01923	ESSEX	USA	Cardiovascular Diseases Research	000	1	6/14/2010	NEW	$199,454
														Subtotal = $199,454

Grand Total All Awards = $1,291,743

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Minimally Invasive Pediatric VAD for Treatment of Acute Heart Failure

Award Number: R44HL099192

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/15/2011

PERIOD OF PERFORMANCE END DATE: 12/31/2014

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer