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Over a decade has passed since hope was raised worldwide that MEMS could make blindness a curable condition. Now the long wait is finally over, with all the necessary tests and clinical trials clearing the final hurdles. Last month, the U.S. Food and Drug Administration (FDA) approved the final clinical trials for the Argus II retina developed by the Department of Energy's (DoE) Artificial Retina Project, based on the pioneering work of Mark Humayun at the Doheny Eye Institute of the University of Southern California and Second Sight Medical Products, Inc. Also this month, a second and simpler implant, called the "Implantable Telescope" by its maker, VisionCare Corp., received final FDA approval, making millions of legally blind worldwide eligible for the sight-restoring implant.
Most articles on MEMS related topics tend to cover large markets in automotive and consumer electronics, not the treatment of debilitating illnesses of the nervous system. But even though the market for neurological applications today is small, MEMS and microfabrication technologies are helping neuroscience researchers in their quest to understand the workings of the brain, advancing knowledge in one of the most exciting fields of scientific endeavor today. And what is more exciting, MEMS technologies are already being deployed in medical devices to treat injuries and diseases of the nervous system, with several products already in human clinical trials and more expected within the next twelve months. Some of these products, quite literally, have neurosurgeons surgically implanting “MEMS on the brain”.
The aim of a $1.6 million Office of Naval Research program is to create a microfluidic hospital on-a-chip by 2012 that can be deployed on the battlefield to monitor a soldier's injuries and administer medications. Today injured soldiers are left where they lie -- after being shot, stunned or made victims of shrapnel wounds -- until "hot zones" cool off enough for medics to reach them. But if each solider wore a hospital on-a-chip as a part of their standard-issue gear, then their condition could be assessed with microfluidic devices that harness MEMS techniques to diagnose and administer appropriate drugs to stabilize the injured soldiers’ condition until medics can reach them.
Conventional immunoassay technologies such as enzyme-linked immunosorbent assay (ELISA) and western blot for life sciences and diagnostic applications are time consuming, requiring multiple manual steps in order to achieve assay results. To address this, BioScale, Inc. (Cambridge, Mass.) has integrated sample preparation and microparticle techniques with non-optical MEMS based detection and quantification technology.
Based on the company’s acoustic membrane microparticle platform,
only a few basic steps are needed for lab technicians to run an assay,
and multiple assays can be run at the same time. BioScale is marketing its
products in bioanalytic and bioprocess markets – both areas that the company says require better analytical tools that work well in complex samples.
Applications are years away yet, but Georgia Institute of Technology researchers have demonstrated that piezoelectric nanowires can harvest energy from repetitive motions inside the body -- even the beating of your heart. Future applications could include powering implants -- such as pacemakers -- that today require periodic surgeries just to change their batteries.
The American Cancer Society estimates that there will be more than 1.5 million new cancer cases diagnosed in 2010. A biopsy is a widely used method of identifying malignant tumors by studying surgically removed tissue under the microscope. It is a time-consuming and stressful process even if the tumor proves benign. In fact, a large percentage of biopsies come up negative.
To address this problem, Dresden based Fraunhofer Institute for Photonic Microsystems is now developing a MEMS device that allows in vivo diagnostic procedures using an endoscope. Expected to be available in the near future, it is a minimally invasive alternative to biopsies with the added advantage of providing diagnosis in real time.
CardioMEMS, Inc. currently has its latest wireless MEMS device in clinical trials -- an implantable heart failure monitor designed to measure pulmonary artery pressure. High pulmonary artery pressure is associated with fluid build-up in the lungs that occurs with the progression of heart failure. It is a condition in which a weakened heart muscle cannot pump enough blood through the body that affects over 5 million Americans and is the leading cause of hospitalization in the United States.
We recently spoke with Eric Le Royer, CEO of Geneva-based Endosense, about how his company applied MEMS technology to the development of a new catheter to improve the procedures for treating atrial fibrillation. According to Mr. Le Royer, atrial fibrillation is today’s most prevalent cardiac rhythm disorder and is estimated to affect more than 6 million people worldwide. Of these, approximately 2.6 million cases have been treated by three types of therapy – 2.5 million with drugs, 60,000 with surgery and 70,000 with conventional catheter ablation. The catheter market for treating atrial cardiac disorder is expected to grow from $500 million today at a rate of 20% per annum and reach $1.25 billion in 2015.
According to Professor Pierre Dupont, there are currently two approaches to perform repairs inside the heart – open heart surgery and catheter interventions. Dupont, who recently was awarded a $5 million NIH grant to perform work in this area, believes there is a better way. Interestingly, he picked MEMS as the technology of choice for his project and is collaborating with Microfabrica, a microdevice manufacturer based in California. We recently spoke with Professor Dupont about his goals and why the size advantages of MEMS really matter in this case.
Aldagen, a venture funded startup with a set of technologies to identify and isolate stem and progenitor cells, has recently announced a partnership with IMT to develop a microfluidic device for clinical cell sorting. We recently spoke with the President and COO of the company, Ed Field, and discussed Aldagen’s business model, marketing and regulatory approval efforts as well as its ongoing round of financing.
Over a decade has passed since hope was raised worldwide that MEMS could make blindness a curable condition. Now the long wait is finally over, with all the necessary tests and clinical trials clearing the final hurdles. Last month, the U.S. Food and Drug Administration (FDA) approved the final clinical trials for the Argus II retina developed by the Department of Energy's (DoE) Artificial Retina Project, based on the pioneering work of Mark Humayun at the Doheny Eye Institute of the University of Southern California and Second Sight Medical Products, Inc. Also this month, a second and simpler implant, called the "Implantable Telescope" by its maker, VisionCare Corp., received final FDA approval, making millions of legally blind worldwide eligible for the sight-restoring implant.
