A miniature, battery-free, wireless, cardiac implant being developed by a U-M researcher and the Ann Arbor company Integrated Sensing Systems, Inc. (ISSYS), has received important 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, Inc., to complete the final preclinical testing required before seeking approval under Food and Drug Administration’s Humanitarian Device Exemption pathway. Bocks is a pediatric cardiologist with the University of Michigan Congenital Heart Center and the U-M C.S. Mott Children’s Hospital.
“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,” says Bocks, the project’s medical principal investigator.
“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 – which will be used 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, Bocks says. 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 the 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.”
“We also hope that it will help us conduct more research,” he adds. “We’ll be able to obtain information from patients when they are sleeping, or exercising – information we had not been able to get to before.”
The device is important because it will allow researchers to conduct more tests on these patients, which will lead to better treatments, says Nader Najafi, Ph.D., ISSYS President and CEO and the project’s technical principal investigator.
“This grant helps us develop wireless, intelligent, miniature implants for patients with congenital and structural heart diseases. It paves the way for the start of clinical studies in infants and children with complex congenital heart defects,” he says.
“The pediatric medical device field represents unique commercialization challenges due to its small size and stringent requirements,” Najafi adds. “We are grateful to the NIH for this needed support for the challenging pediatric device field. The results of this effort will have important spillover effects for broader applications within the field of adult and pediatric cardiovascular medicine.”
About C.S. Mott Children’s Hospital:
The University of Michigan C.S. Mott Children’s Hospital is consistently ranked as one of the best hospitals in the country. It was nationally ranked in all ten pediatric specialties in the U.S. News Media Group’s 2011 edition of “America’s Best Children’s Hospitals” including third in the country for heart and heart surgery. The hospital is now in a new 1.1 million square feet, $754 million state-of-the-art facility that is home to cutting-edge specialty services for newborns, children and women.
ISSYS is a leader in advanced MEMS technologies for industrial, medical devices, microfluidic and scientific analytical sensing applications. Founded in 1995, ISSYS is one of the oldest independent MEMS companies in the US. ISSYS operates a “full manufacturing under one roof,” multi-million-dollar, state-of-the-art MEMS fabrication facility located near Ann Arbor, Michigan. ISSYS’ quality system is ISO 9001:2008 and ISO 13485:2003 (medical products) certified. The quality system is also compliant to EN 13980:2002 for its ATEX/IECEx approved intrinsically-safe products. ISSYS is a vertically integrated company dedicated to developing and manufacturing system-level products based on MEMS technology (MEMS Inside). Please visit: http://www.mems-issys.com/
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