Medical Devices

The path to impact for basic life science research can be long and filled with big gaps: in time and in resources.

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McGowan Institute for Regenerative Medicine Yu-li Wang, PhD, and his team are researching cell migration while using the technologies developed for potential applications in artificial organs and other devices. The team has been awarded a five-year research grant from the National Institute of General Medical Sciences (NIGMS), one of the National Institutes of Health, to support this work.

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The team led by researchers at Carnegie Mellon University (CMU) has created a new technology that enhances scientists’ ability to communicate with neural cells using light.  McGowan Institute for Regenerative Medicine affiliated faculty member Tzahi Cohen-Karni, PhD, CMU’s associate professor of biomedical engineering and materials science and engineering, led a team that synthesized three-dimensional fuzzy graphene on a nanowire template to create a superior material for photothermally stimulating cells. NW-templated three-dimensional (3D) fuzzy graphene (NT-3DFG) enables remote optical stimulation without the need for genetic modification and uses orders of magnitude less energy than available materials, preventing cellular stress.  This work was presented in the Proceedings of the National Academy of the Sciences.

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The Center for Disease Control estimates that roughly 40,000 infants are born with congenital heart defects (CHDs) each year. Among that population, 25 percent are critical cases that require cardiac surgery. The waitlist for a heart transplant continues to grow; yet, the only FDA-approved life-saving device for CHD has shortcomings and is based on technology from the 1970s.

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Acute kidney injury is common in hospitalized patients, particularly those in intensive care units and older adults, and refers to a sudden episode of kidney failure or damage that happens within a few hours or days. It causes a build-up of waste products in the blood that can affect other organs, including the brain, heart, and lungs.

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A respiratory dialysis system that was developed at the McGowan Institute for Regenerative Medicine Medical Devices Lab has been used to treat 16 COVID-19 patients, in conjunction with non-invasive or mechanical ventilation.  The core technology developed at the Medical Devices Lab, was licensed to the spinout ALung Technologies, and ALung has designed and produced a clinically viable device, which is called the Hemolung® Respiratory Assist System (RAS).

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In Pennsylvania and other U.S. states, one of the keys to safely reopening society amid the COVID-19 pandemic is providing sufficient testing so that new cases of the disease do not overwhelm the public healthcare system. University of Pittsburgh professors—led by McGowan Institute for Regenerative Medicine affiliated faculty member Wei Gao, PhD—are  reimagining testing using a device that nearly every American owns — a smartphone.

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Researchers at Carnegie Mellon University (CMU) and the University of Pittsburgh School of Medicine are developing a new, low-cost ventilator they say will address the ventilator shortage, both now and in the future, that has been made evident by the COVID-19 pandemic.  The team includes McGowan Institute for Regenerative Medicine affiliated faculty member Keith Cook, PhD, a CMU professor of biomedical engineering.  Dr. Cook, of CMU’s Biomedical Engineering Department, has expertise in advanced respiratory support, including the design and development of artificial lungs, liquid ventilation hardware and techniques, and animal models of lung disease.

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A multidisciplinary team of researchers and clinicians, including McGowan Institute for Regenerative Medicine faculty member Peter Rubin, MD, FACS, Chair of the Department of Plastic Surgery, the UPMC Endowed Professor of Plastic Surgery, Director of UPMC Wound Healing Services, and Professor of Bioengineering at the University of Pittsburgh, is working on a low-cost negative pressure hood that can be used to protect medical staff during intubations and other situations where aerosol spray is likely from infected patients. Moreover, it can also help prevent spread in environments without a negative pressure room, such as the Emergency Department of a hospital. This apparatus is different and far advanced compared with static protection boxes which are only passive shields.  What makes this new hood most remarkable is its active airflow and HEPA filtering.

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A device designed at the McGowan Institute for Regenerative Medicine could help improve outcomes as a treatment for COVID-19 when used in conjunction with non-invasive or mechanical ventilation, and it recently received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. Health records from a New York study showed that close to 90 percent of patients who were placed on mechanical ventilation did not survive. Some intensive care units are now considering mechanical ventilation as a last resort because of the complications and side effects associated with the process, and researchers believe this device could help.

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Under the direction of McGowan Institute for Regenerative Medicine faculty member William Federspiel, PhD, the William Kepler Whiteford Professor in the Department of Bioengineering at the University of Pittsburgh, the Institute’s Medical Devices Laboratory is developing clinically significant devices for the treatment of pulmonary and other cardiovascular ailments by utilizing the engineering principles of fluid flow and mass transfer.

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Approximately one in every 125 babies in the U.S. is born with a congenital heart defect (CHD), making it the country’s most common birth defect. Heart valves developed for adults have been used on infants to treat CHDs, but the large devices sometimes require open heart surgery, presenting a severe risk to infants and young children. Additionally, infants and children grow quickly, but the artificial valve does not, resulting in repeated surgeries that increase risks.

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A multi-institution research team led by the University of Pittsburgh secured a $22 million grant from the Defense Advanced Research Projects Agency (DARPA) to develop a device combining artificial intelligence, bioelectronics and regenerative medicine to regrow muscle tissue, especially after combat injuries.

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Neural stimulation is a pioneering technology that can be used to recover function and improve the quality of life for individuals who suffer from brain injury or disease. It serves an integral role in modern neuroscience research and human neuroprosthetics, including advancements in prosthetic limbs and brain-computer interfaces. A challenge that remains with this technology is achieving long-term and precise stimulation of a specific group of neurons.

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Abbott Laboratories, the Abbott Park, Illinois-based health care giant, has won approval from the U.S. Food and Drug Administration (FDA) for a less invasive surgical procedure that allows surgeons to implant the company’s heart pump without a patient undergoing open heart surgery.

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Renerva, a medical startup that is developing an injectable gel to speed the healing of damaged nerves and creating an off-the-shelf nerve-graft product that may spare patients life-long disability, has joined Cornell University’s McGovern Center life sciences business incubator.

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McGowan Institute for Regenerative Medicine affiliated faculty member Krzysztof Matyjaszewski, PhD, is the Co-Founder and CSO of BioHybrid Solutions, LLC (BHS), a Pittsburgh-based protein engineering company, which recently received a contract worth up to $30 million from the United States Department of Defense to develop a next-generation prophylactic medical countermeasure. The project was sponsored by the U.S. Government through the Medical CBRN Defense Consortium (MCDC).  Dr. Matyjaszewski is the J.C. Warner Professor of Natural Sciences at Carnegie Mellon University.

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Garrett Coyan, MD, sees many patients each week, from children to the elderly, to check on their replacement heart valves.

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The brain is a complex organ full of neurons that work together to help us move, feel, think, and more. A multidisciplinary group from the University of Pittsburgh (Pitt) and Carnegie Mellon University (CMU) is working to expand the amount of information researchers can receive from a neural interface device and received two grants from the National Science Foundation (NSF) for their collaborative effort.

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Magnesium and magnesium alloys have the potential to become a revolutionary material for a variety of industries because of their lightweight structure and ability to quickly biodegrade in water or inside the human body. Researchers, however, are still struggling to process this very reactive metal to eliminate defects that accelerate corrosion.

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McGowan Institute for Regenerative Medicine affiliated faculty member Richard Debski, PhD, professor of bioengineering at the University of Pittsburgh and the co-director of the Orthopedic Robotics Laboratory, is a member of a team of researchers on a project which received $400K from the NIH to design and test a miniature, implantable, and battery-free sensor to monitor spinal fusion progress after surgery.

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The recent Pittsburgh Post-Gazette newspaper article by Jill Daly highlights the significant challenges infants and children face if they require a heart transplant.

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Renerva, LLC, a medical device company developing innovative technologies for peripheral nerve repair, announced recently that it has received two additional grants totaling $500,000 from the National Science Foundation (NSF) and the National Institutes of Health (NIH), rapidly accelerating development of their medical device products.

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While 3D printing soft materials, such as silicone or proteins, offers many advantages, it also introduces many new and complicated variables to consider when creating a new part, per Vanesa Listek for 3D Print in her report featuring the work of McGowan Institute for Regenerative Medicine affiliated faculty member Newell Washburn, PhD, professor of biomedical engineering and chemistry at Carnegie Mellon University (CMU). The existing soft materials that can be 3D printed commercially are somewhat limited since they don’t have all the properties that researchers need to fully advance their developments and they end up working within the constraints of the current technology.

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McGowan Institute for Regenerative Medicine affiliated faculty member Keith Cook, PhD, a professor of biomedical engineering at Carnegie Mellon University (CMU), is working to give new hope to patients with chronic lung disease.

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The Disabled Veterans National Foundation (DVNF), a nonprofit veterans service organization that provides critically needed support to disabled and at-risk veterans who leave the military wounded—physically or psychologically—after defending our safety and our freedom, presented a grant of $50,000 to the Human Engineering Research Laboratories (HERL).

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Technology developed in the McGowan Institute Medical Devices Lab under the leadership of William Federspiel, PhD, William Kepler Whiteford Professor of Bioengineering, Chemical Engineering, and Critical Care Medicine, has been incorporated into products for clinical use by ALung, a University of Pittsburgh spinout company.  Dr. Federspiel is the Head of the Scientific Advisory Board and co-founder of ALung Technologies, Inc. The ALung devices are now being evaluated in several clinical trials.   ALung is the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure.

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Krzysztof Matyjaszewski, PhD, the J.C. Warner University Professor of Natural Sciences in the Department of Chemistry at Carnegie Mellon University (CMU) and a McGowan Institute for Regenerative Medicine affiliated faculty member, along with researchers from CMU’s Mellon College of Science and College of Engineering have developed a semiliquid lithium metal-based anode that represents a new paradigm in battery design. Lithium batteries made using this new electrode type could have a higher capacity and be much safer than typical lithium metal-based batteries that use lithium foil as anode.  The semiliquid metal anode could be used to create high capacity batteries for electric vehicles and specialized batteries for use in wearable devices that require flexible batteries, examples of far-reaching impact.

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Patients with left-sided heart failure who get implanted devices to improve the pumping of their hearts may be more likely to develop heart failure on the opposite side of their hearts if they are pre-treated with off-label selective vasodilator drugs, according to new research published in Circulation: Heart Failure, an American Heart Association journal.  McGowan Institute for Regenerative Medicine Deputy Director Robert Kormos, MD, FAHA, Professor of Cardiothoracic Surgery and Bioengineering at the University of Pittsburgh, past director of UPMC’s Artificial Heart Program, and the Brack G. Hattler Chair of Cardiothoracic Transplantation, is a co-author on this study.

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A team of polymer chemists and engineers from Carnegie Mellon University (CMU) including McGowan Institute for Regenerative Medicine affiliated faculty member Krzysztof Matyjaszewski, PhD, the J.C. Warner Professor of Natural Sciences at CMU, has developed a new methodology that can be used to create a class of stretchable polymer composites with enhanced electrical and thermal properties. These materials are promising candidates for use in soft robotics, self-healing electronics and medical devices. The results are published in Nature Nanotechnology.

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Pelvic organ prolapse (POP) is a condition where the organs in the pelvis push against the vagina, creating a “bulge” that can extend outside of the body. It results from a weakening of the muscles and tissues that help support the pelvic organs. This disorder affects many women, but surgical treatments with polypropylene mesh – devices initially designed for hernia repairs, not vaginal use – often result in complications.

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Inari Medical, Inc. announced the publication of its 106-patient prospective multicenter FlowTriever Mechanical Pulmonary Embolectomy (FLARE) study for the treatment of intermediate-risk pulmonary embolism (PE).  The study was published in JACC: Cardiovascular Interventions.  FLARE was conducted under the direction of co-principal investigators, Kenneth Rosenfield, MD, Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital, Boston, and Victor Tapson, MD, Associate Director, Pulmonary and Critical Care Division at Cedars-Sinai Medical Center, Los Angeles.

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Starfish can repair injured arms and reptiles can regrow severed tails; from bacteria to humans, every species is capable of regeneration, albeit to variable extents. These functions help make species more resilient, but how can we apply the knowledge of these regenerative mechanisms to improve human health? The University of Pittsburgh Department of Bioengineering has been collaboratively working to address this question through research efforts in tissue engineering and regenerative medicine.

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Technology developed in the McGowan Institute Medical Devices Lab under the leadership of William Federspiel, PhD, William Kepler Whiteford Professor of Bioengineering, Chemical Engineering, and Critical Care Medicine has been incorporated into products for clinical use by ALung, a University of Pittsburgh spinout company.  Dr. Federspiel is the Head of the Scientific Advisory Board and co-founder of ALung Technologies, Inc. The ALung devices are now being evaluated in several clinical trials.   ALung is the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure.

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McGowan Institute for Regenerative Medicine affiliated faculty member John Kellum, MD—Professor in the Departments of Critical Care Medicine, Medicine, Bioengineering, and Clinical and Translational Science at the University of Pittsburgh and the Director of the Center for Critical Care Nephrology and the Vice-Chair for Research, both appointments in the Department of Critical Care Medicine—is the lead investigator on a pilot study for the RenalSense® Clarity RMS® critical care monitoring system being conducted at the University of Pittsburgh Medical Center (UPMC).

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The Pennsylvania Pediatric Medical Device Consortium (PPDC) has announced a partnership with two programs at the University of Pittsburgh. Formerly the Philadelphia Pediatric Medical Device Consortium, the PPDC’s new name reflects its statewide reach. This expansion comes on the heels of a five-year, $6 million grant renewal from the Consortium’s sponsor, the U.S. Food and Drug Administration.

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Inari Medical, Inc. announced the enrollment of the first patient in the FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (“FLASH”) using the FlowTriever® System for the treatment of pulmonary embolism (PE).  McGowan Institute for Regenerative Medicine affiliated faculty member Catalin Toma, MD, Interventional Cardiologist, UPMC Presbyterian, is the Principal Investigator for FLASH.

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The U.S. Food and Drug Administration announced that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children’s medical devices.

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McGowan Institute for Regenerative Medicine affiliated faculty member Rory Cooper, PhD, FISA & Paralyzed Veterans of America Professor and Distinguished Professor of the Department of Rehabilitation Science & Technology, professor of Bioengineering, Physical Medicine & Rehabilitation, and Orthopedic Surgery at the University of Pittsburgh, and Founding Director and VA Senior Research Career Scientist of the Human Engineering Research Laboratories—a VA Rehabilitation R&D Center of Excellence in partnership with Pitt—participated in the recent VA Research Fair in Washington, DC.  He demonstrated MEBot, a wheelchair which can climb stairs.

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It seems like something straight out of a science fiction movie: humans wearing bionic technology to move more easily.

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