heart
SBIR Success Stories
Smaller, Cheaper Heart Assist Pumps Could Improve Lives of Heart Failure Patients

Patients with heart failure sometimes need an external pump to assist the heart in circulating blood throughout the body. With small business research funding from the National Heart, Lung, and Blood Institute (NHLBI), medical device maker Levitronix successfully developed and marketed external blood pumps to provide short-term circulatory support to adult and pediatric heart failure patients.

Smaller, more affordable external blood pumps provide critical support for heart failure patients

Heart failure is a common and debilitating condition in which the heart cannot pump sufficient blood to meet the body's needs. In some cases, the heart is unable to fill with enough blood. In others, it is too weak to pump blood throughout the body. It is possible to have both problems at the same time.

About 5.7 million people suffer from heart failure in the United States. When medicines and other treatments are no longer effective, a mechanical pump may be used to support one or both of a patient’s lower heart chambers, or ventricles.

Some cardiac assist pumps are surgically implanted in the patient’s chest while others operate outside the body. External pumps are typically used when a patient requires short-term circulatory support as a bridge to long-term treatment, such as a heart transplant.

The use of external pumps to treat heart failure patients has been limited by the size and cost of the devices. In recent years, however, medical device developers have sought to create smaller, lower-cost external pumps. The NHLBI Small Business Innovation Research (SBIR) program has been at the forefront of efforts to support research and development on a new generation of external blood pumps.

Levitronix was founded in 2001 to develop magnetically levitated, bearing-free pumps for the semiconductor and medical industries. The rotating parts of these pumps are suspended by magnetic fields to eliminate friction from surfaces. A key advantage of magnetic levitation (or “maglev”) for blood pumps is the absence of contact between the rotor and the pump housing, which prevents the rupture or destruction of red blood cells.

NHLBI funds development of Levitronix blood pumps

CentriMag Mechanical Circulatory Support System
CentriMag Mechanical Circulatory Support System

Levitronix received the first of four NHLBI SBIR grants in 2003. Two awards funded research and development on miniature, low-cost, external blood pumps — CentriMag and PediMag — for adult and pediatric patients (PediMag is called PediVAS outside of the United States). These pumps are used as short-term bridge therapies in patients with severe heart failure.

Two additional SBIR grants supported the testing and market launch of the CentriMag and PediMag pumps. Clinical trials provided insights into preventing blood clots and weaning patients off the pumps. The U.S. Food and Drug Administration approved CentriMag in 2008 — the first maglev blood pump on the market — followed by PediMag in 2009 specifically for pediatric patients.

Levitronix also participated in the NHLBI-supported Pumps for Kids, Infants and Neonates (PumpKIN) research program. This research effort sought to develop and test a circulatory support pump to sustain young heart failure patients while they are recovering or waiting for a heart transplant.

The medical division of Levitronix was acquired by Thoratec Corporation in 2011.

Quote by Kurt Dasse, Ph.D.

 

 

 

Summary:

SBIR funding from the NHLBI was instrumental in enabling Levitronix to develop and commercialize compact, portable maglev blood pumps that provide short-term circulatory support to adults and children with heart failure.

More about the NHLBI SBIR and STTR programs

The NHLBI Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support research and development on the next generation of commercially promising technologies and products to prevent, diagnose, and treat heart, lung, blood, and sleep-related diseases and disorders. For more information on NHLBI’s small business programs, visit http://www.nhlbi.nih.gov/research/funding/sbir/about-program

Disclaimer

Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Heart, Lung, and Blood Institute (NHLBI), the NHLBI's Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, or any other portion of the U.S. Government.