Saturday, February 11, 2012

Addressing Cardiovascular Defects

A miniature battery-free, wireless cardiac implant device is being developed by a University of Michigan research team led by Martin Bocks, MD and the Ann Arbor company Integrated Sensing Systems, Inc (ISSYS). The university researchers and ISSYS received a $1.5 million grant from NIH’s National Heart Lung and Blood Institute (NHLBI).

The funding is going to be used to complete the final preclinical testing required before seeking approval from FDA under the Humanitarian Device Exemption pathway. The grant funding will help test a device that will reduce the need for invasive cardiac catheterization procedures. The research team has been working on this device for three years and anticipates that it will be used in infants and children.

Bocks a Pediatric Cardiologist with the University’s Congenital Heart Center and the university’s C.S Mott Children’s Hospital, reports that the device has the potential to greatly improve the care that we provide to complex patients and will provide researchers with unprecedented opportunities to learn more about their unique physiology.

The wireless device is to be implanted within a heart chamber. Once the device is 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, this monitoring may be performed remotely or patients can be monitored from the home.

The device would stay in place permanently and would be used in patients with functional single ventricle conditions, such as hypoplastic left heart syndrome but could be used in other forms to treat pediatric and adult heart disease in the future.

Researchers are hopeful that the device will go to market by 2013. According to Nader Najafi, PhD, ISSYS President and CEO and the project’s technical principal investigator, “The pediatric medical device field represents unique commercialization challenges due to its small size and stringent requirements.

For more information, go to or contact Margarita Wagerson at the University of Michigan at

The University of Minnesota is looking into licensing possibilities for a device developed to treat cardiovascular defects. A septal defect is a type of congenital heart defect that allows blood flow between the atria or ventricles. Current closure devices generally contain metallic features to provide shape support. These devices can erode into surrounding tissue and corrode over the 70 year potential lifetime of the device.

Newer devices include self-centering features to reduce the potential for residual leaks and can provide complete occlusion of the defect. However, due to the presence of metallic wires, these devices are bulky and can cause unintended flow disruptions.

A solution for the problem is to use a non-metallic closure device. The ideal solution for cardiovascular defects is to use a temporary device that can be resorbed by the body and replaced with native tissues.

A device has been developed that can completely occlude defects, and be retrieved back to the catheter in the event of sub-optimal deployment. The device is designed to be bioresorbable and does not have metallic components. This simplifies the manufacturing of the device and allows the device to degrade over time and then be replaced by natural fibrous tissue in the body. For more information on this device, go to or call (612) 624-0550.