News | January 27, 2012

Congenital Heart Patients to Benefit From Wireless, Battery-Free Cardiac Implant

January 27, 2012 — A miniature, battery-free, wireless, cardiac implant being developed by a University of Michigan researcher and the Ann Arbor, Mich., company Integrated Sensing Systems, Inc. (ISSYS), has received funding that could get it to patients more quickly.

A $1.5 million grant from the National Institutes of Health (NIH) will help a research team, led by Martin Bocks, M.D., and ISSYS, to complete the final preclinical testing required before seeking approval under the U.S. Food and Drug Administration's (FDA) Humanitarian Device Exemption pathway. 

"We are extremely excited to continue working with ISSYS to develop a wireless, implantable pressure sensor for our patients with complex forms of congenital heart disease," said Bocks, the project's medical principal investigator, and pediatric cardiologist at the University of Michigan Congenital Heart Center and the U-M C.S. Mott Children's Hospital.

"This pressure sensor has the potential to greatly improve the care we provide to our most complex patients and will provide us with unprecedented opportunities to learn more about their unique physiology. We appreciate the NIH and the National Heart Lung and Blood Institute (NHLBI) for their willingness to fund research on patients with rare, severe forms of congenital heart disease."

Bocks and his team at U-M have been working on this device – intended for use in infants and children -- for three years. The 2.5-year grant will help test a device that will reduce the need for invasive cardiac catheterization procedures and provide a better understanding of congenital heart disease.

The device is a wireless, battery-free, miniature pressure sensor that is implanted within a heart chamber. Once implanted, doctors can measure pressure inside the heart while the patient is being seen in the outpatient clinic without having to do a heart catheterization.  In the future, such monitoring may be performed remotely or from home.

The device, which would stay in place permanently, is initially planned for use in patients with functional single ventricle conditions, such as hypoplastic left heart syndrome. It could be used in other forms of pediatric and adult heart disease in the future.

"We hope it would be going to market by year 2013," Bocks says. "We expect the device to decrease the number of heart catheterizations, help doctors better monitor the effects of medications, and provide early detection for conditions such as blood clots in lungs."

For more information: www.mems-issys.com

Related Content

Medtronic Receives FDA Approval for Less-Invasive Heart Pump Implant Procedure
Technology | Ventricular Assist Devices (VAD) | July 17, 2018
Medtronic plc recently received U.S. Food and Drug Administration (FDA) approval for a less-invasive implant approach...
CorWave's Next-generation Neptune LVAD Receives Funding

Image courtesy of CorWave

News | Ventricular Assist Devices (VAD) | July 11, 2018
French-based CorWave announced that its CALYPSO program has received 14 million euros to develop CorWave Neptune, a new...
Abbott Recalls the HeartMate 3 Left Ventricular Assist System, LVAD
News | Ventricular Assist Devices (VAD) | May 23, 2018
Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the...
FDA Approves Abiomed Impella CP With SmartAssist and Optical Sensor
Technology | Ventricular Assist Devices (VAD) | April 02, 2018
Abiomed Inc. announced that it received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its...
Reduced Device Clotting, Decreased Strokes Seen With HeartMate 3 at Two Years
News | Ventricular Assist Devices (VAD) | March 13, 2018
At two years of follow-up, severely ill patients with advanced heart failure who received a novel heart pump fully...
Medtronic HeartWare HVAD System Approved for Destination Therapy
Technology | Ventricular Assist Devices (VAD) | October 04, 2017
October 4, 2017 — Medtronic received U.S.
Abiomed Receives FDA PMA Approval for Impella RP for Right Heart Failure
Technology | Ventricular Assist Devices (VAD) | September 28, 2017
Abiomed Inc. recently received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for the Impella RP ...
Abbott Receives FDA Approval for HeartMate 3 Left Ventricular Assist System
Technology | Ventricular Assist Devices (VAD) | August 29, 2017
Abbott announced it has received U.S. Food and Drug Administration (FDA) approval for its Full MagLev HeartMate 3 Left...
Pre-PCI Impella 2.5 Insertion Improves Survival in Left Main Coronary Artery Heart Attacks
News | Ventricular Assist Devices (VAD) | June 30, 2017
Abiomed Inc. announced the recent publication of a peer-reviewed retrospective study on hemodynamic support with the...
Overlay Init