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CompuFlo Epidural Anesthesia System Measures Pressure at Needle’s Tip, Cleared by FDA

CompuFlo Epidural Anesthesia System Measures Pressure at Needle’s Tip, Cleared by FDA

Milestone Scientific, Inc., a company out of Livingston, New Jersey, achieved FDA clearance for its CompuFlo Epidural Computer Controlled Anesthesia System. Milestone’s DPS Dynamic Pressure Sensing Technology is able to provide precise and continuous measurement of the pressure at the tip of the syringe, both helping to guide anesthesiologists when accessing the epidural space and recording the procedure for any post-op review. As the needle is advanced, the device provides both visual and audio feedback regarding the pressure levels being detected. Here’s a bit of detail about the study that has helped to result in the FDA clearance, according to Milestone Scientific: This clearance was supported by the COMPASS Study (CompuFlo® Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo® Epidural Instrument. The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundred-sixty (160) required epidural procedure for acute pain management during labor and delivery. The CompuFlo® Epidural with Dynamic Pressure Sensing Technology resulted in the anesthesiologists objectively identifying the epidural space with 99% success on the first attempt. The COMPASS study involved use of the CompuFlo Epidural in 21 obese subjects (BMI > 31), with performance in this group found to be comparable to the performance seen in patients with lower BMIs....
New MRI Probe Highlights Fibrogenesis to Help Track Scar Formation Noninvasively

New MRI Probe Highlights Fibrogenesis to Help Track Scar Formation Noninvasively

Tissue injuries often result in fibrogenesis, a process involving the development of an extracellular matrix that results in scars. While it can be viewed on the exterior of the body, currently there are no noninvasive methods to track the progress of fibrogenesis within the body’s interior. A team of researchers at Harvard Medical School have now developed a chemical probe that can be used to spot and quantify the amount of fibrogenesis using MRI scanners. The probe is a gadolinium chelate (GdOA) which binds to allysine, an amino acid that’s present where collagen is creating connections. It concentrates at particularly high quantities where a great deal of fibrogenesis takes place, but doesn’t when a disease has stabilized. The gadolinium has an oxyamine functional group that binds to allysine, and because gadolinium is well visible under MRI, it highlights the locations of fibrogenesis. In addition to clinical applications, this new probe will help to study diseases and injuries that involve fibrogenesis, potentially leading to new therapies and preventive strategies. Study in journal Angewandte Chemie: Molecular Magnetic Resonance Imaging of Lung Fibrogenesis with an Oxyamine-Based Probe… Via:...
Stryker’s MultiGen 2RF Generator for Facet Joint Ablations Cleared by FDA

Stryker’s MultiGen 2RF Generator for Facet Joint Ablations Cleared by FDA

Stryker, a company best known for orthopedic devices, won FDA clearance to introduce its MultiGen 2 RF Generator in the U.S. The device is used to treat pain deriving from facet joints in the spine by delivering radiofrequency energy that ablates targeted tissues. Compared to the previous version of the device, Stryker claims that the MultiGen 2 provides improved control, reliability, and procedural efficiency. The device produces twice the amount of power compared to most standard devices of this type, getting up to temperature quicker with fewer opportunities for errors to occur. A single button starts the procedure, while removing electrodes is not necessary when creating strip lesions that are the signature of facet joint RF ablation. There are a number of settings that can be adjust depending on the patient needs and physician preferences, allowing for quick turnaround and intuitive pre-op steps that make it easy to get started. Via:...
New Tissue Glue Can be Clearly Seen With X-Rays and Ultrasound

New Tissue Glue Can be Clearly Seen With X-Rays and Ultrasound

Nanoparticles made with a shell of silica (SiO2) and a core of radiopaque tantalum oxide (TaOx) are used to make a tissue adhesive and visible to ultrasound, X-ray, and fluorescent imaging. Researchers at Korea’s Institute for Basic Science and Seoul National University Hospital have designed and tested a glue for binding tissues that also works as a contrast agent for X-rays, CTs, and ultrasound imaging modalities. This is the first such tissue glue to have this set of properties, and, if approved for clinical applications, may end up displacing other adhesives because it can be later easily monitored as to how it’s holding tissues together. The material is made of nanoparticles that have tantalum oxide at their center, a radiopaque material, and a silica exterior that provides the gluing action. Tested to exhibit less cellular toxicity than a combination of FDA approved cyanoacrylate, a tissue adhesive, and lipiodol, a radiopaque contrast agent (CA-Lp), the new material was successfully used to repair a damaged liver, and connect moving tissues of the lung and limbs in laboratory animals. Its radiopaque properties were similar to lipiodol and it was about as visible as cyanoacrylate under X-rays. Nanoparticles made with a shell of silica (SiO2) and a core of radiopaque tantalum oxide (TaOx) are used to make a tissue adhesive and visible to ultrasound, X-ray, and fluorescent imaging. From Institute for Basic Science: CA-Lp tends to trigger immune reaction within 3 days from the operation and inflammation after 14-65 days, while experiments showed that TSN did not show such adverse effects after 56 days. TSNs also ensured accurate target localization during movement; when TSNs...
Vericred Announces Medicare Advantage Market Addition to Health Insurance Data Platform

Vericred Announces Medicare Advantage Market Addition to Health Insurance Data Platform

Last month Vericred, a healthcare data services company, announced the addition of a provider-network notification capability to its suite of services, a first for the healthcare data industry. This week, Vericred took another important step to expand their offering with the addition of Medicare Advantage plan design and rate data, provider-network data, and formulary data. This expansion means that technology companies, especially those focused on transparency and decision support, can leverage Vericred’s expanded database to know where a plan is available, how much a plan costs, what it covers, and information about the plan’s deductible, co-pay, and which drugs are covered by the plan along with their tier level and restrictions. A single point of integration through Vericred’s REST API makes it easy for these technology companies to take advantage of hundreds of new Medicare Advantage plan-specific data elements. Additional details regarding which doctors and facilities are participating in each Medicare Advantage network are also critical for those companies interested in implementing Vericred’s new offering to help patients with plan selection. While the expansion into the Medicare Advantage market does not yet include Medicare Supplement plan (i.e. Medigap) data, the company plans to begin including this additional data later this year. On the announcement, Vericred Founder and CEO Michael Levin commented that, “…there are numerous coverage options in the Medicare space. As a result, plan choice is a particularly complex process that, to date, has been underserved by technology… Now innovators will have access to the data they need to build solutions for this demanding market.” Link: Vericred homepage… Via:...
Hemopurifier Filters Ebola, Hep C, Metastatic Melanoma: Interview with James A. Joyce, CEO of Aethlon Medical

Hemopurifier Filters Ebola, Hep C, Metastatic Melanoma: Interview with James A. Joyce, CEO of Aethlon Medical

Filtering infectious pathogens and cancer cells directly from whole blood has been an almost fantastic proposition, but the Hemopurifier from Aethlon Medical does just that. We’ve been covering it for over 10 years on Medgadget as it proves itself in clinical trials and new applications for it are discovered. It has already been studied as a treatment option for hepatitis C, metastatic melanoma, and the Ebola virus. Recently at the 2017 BIO International Convention in San Diego, virus capture data was presented from a study of the Hemopurifier involving health-compromised patients infected with a virus. We were offered and took an opportunity to ask James A. Joyce, Chairman and CEO of Aethlon Medical, about the technology within the Hemopurifier, its place in clinical care, and the future potential of the company. Medgadget: Can you summarize for us how the Hemopurifier works and how the technology originated? James A. Joyce: The Hemopurifier is a single-use disposable cartridge that we designed for use within the established infrastructure of dialysis machines and other blood circulatory instruments already located in hospitals and clinical worldwide. From mechanism of action standpoint, the Hemopurifier converges the use of biocompatible plasma membrane technology with a plant-derived lectin known as galanthus nivalis agglutinin (GNA), which has an affinity to bind a broad-spectrum of infectious viruses, yet has limited interactions with human proteins that are essential for health.  In essence, we capture infectious viruses by their surface glycan shield, which is an evolutionary structure that viruses deploy to cloak themselves from being recognized by the host immune system.  As a result, we are able to eliminate circulating infectious viruses before they are able to infect new cells...
Medtronic’s CoreValve Evolut Transcatheter Aortic Valves Now Approved for Intermediate Risk Patients

Medtronic’s CoreValve Evolut Transcatheter Aortic Valves Now Approved for Intermediate Risk Patients

Medtronic has announced that its CoreValve Evolut transcatheter aortic valve replacement platform, consisting of CoreValve, CoreValve Evolut R, CoreValve Evolut PRO, is now FDA approved for patients with “symptomatic severe aortic stenosis who are at an intermediate risk for open-heart surgery.” Previously, the products were only approved for high and extremely risky patients that are not good candidates for an open-heart surgery. The company touts data pointing to its transcatheter valves as having better hemodynamic characteristics compared to surgically implanted devices, and the new approval signals a direction whereby more and more patients will benefit from avoiding heart surgeries. Here’s some details from a study evaluating CoreValve Evolut in intermediate-risk patients, according to Medtronic: Recently unveiled at the 2017 American College of Cardiology meeting, the global SURTAVI trial evaluated intermediate-risk patients and compared 863 TAVR patients treated with the CoreValve and Evolut R Systems (STS: 4.4 percent) to 794 surgical patients (STS: 4.5 percent). Against the strongest surgical performance (compared to predicted surgical risk of mortality) seen to date in a randomized trial, the CoreValve Evolut platform met its primary endpoint of non-inferiority compared to surgery in all-cause mortality or disabling stroke (12.6 percent for TAVR versus 14.0 percent for SAVR; posterior probability of non-inferiority >0.999). The CoreValve Evolut platform also demonstrated significantly better mean aortic valve gradients (7.8 mm Hg vs. 11.8 mm Hg; p<0.001) at two years. SAVR was associated with less aortic regurgitation, major vascular complications and need for permanent pacemaker implantation. Product page: Evolut… Via:...
Optical Fiber for Movement-Free Activation of Select Neurons in Brain

Optical Fiber for Movement-Free Activation of Select Neurons in Brain

Researchers from Istituto Italiano di Tecnologia in Lecce, Italy and Harvard Medical School created a probe designed for optogenetic applications. Optogenetics is a recently developed technique that allows scientists to selectively activate neurons within the brain, and this technology may one day be used as a therapeutic tool to treat a variety of neurological conditions. One current limitation of optogenetics is that illuminating different regions of the brain in a controlled fashion requires moving the fiber optic light source, but in practice this is nearly impossible. The new probe uses a tapered design of an optical fiber that allows it to be used to selectively illuminate both large and small areas of the brain. This is done by controlling the nature of the light that’s sent down the fiber, compensating for what the tapered tip will do to the light. From the study in journal Nature Neuroscience: We use this mode to activate dorsal versus ventral striatum of individual mice and reveal different effects of each manipulation on motor behavior. Conversely, injecting light over the full numerical aperture of the fiber results in light emission from the entire taper surface, achieving broader and more efficient optogenetic activation of neurons, compared to standard flat-faced fiber stimulation. Thus, tapered fibers permit focal or broad illumination that can be precisely and dynamically matched to experimental needs. Study in Nature Neuroscience: Dynamic illumination of spatially restricted or large brain volumes via a single tapered optical fiber… Image and source: Istituto Italiano di...
Nuclear Magnetic Resonance Shows Structure of Proteins at Atomic Resolution

Nuclear Magnetic Resonance Shows Structure of Proteins at Atomic Resolution

Researchers at the University of Stuttgart and Max Planck Institute for Solid State Research in Germany have made quite a breakthrough by being able to study the atom by atom molecular configuration of proteins using a miniaturized version of an MRI scanner. These days the structures of individual protein molecules are impossible to see and various methods, including computer simulations, are used to obtain the probable atomic configuration of protein structures. The new method relies on a very small nuclear magnetic resonance sensor that was developed a few years ago but that was not precise enough to resolve atoms. The German team have since been doing a bit of physics and engineering thinking and tinkering, overcoming what many thought was impossible. From Max Planck Society: To achieve atomic-level resolution, the researchers must be able to distinguish between the frequency signals they receive from the individual atoms of a molecule – in the same way as a radio identifies a radio station by means of its characteristic frequency. The frequencies of the signals emitted by the atoms of a protein are those frequencies at which the atomic bar magnets in the protein spin. These frequencies are very close together, as if the transmission frequencies of radio stations all tried to squeeze themselves into a very narrow bandwidth. This is the first time the researchers in Stuttgart have achieved a frequency resolution at which they can distinguish individual types of atoms. The sensor, which acts as a minute NMR antenna, is a diamond with a nitrogen atom embedded into its carbon lattice close to the surface of the crystal. The physicists...
Medtronic’s Micra Pacemaker Survives Flight to Space

Medtronic’s Micra Pacemaker Survives Flight to Space

This is an update to a recent story of ours on the first pacemaker in space. The Medtronic Micra is the smallest pacemaker currently available. It’s so small that it’s delivered via a catheter and attached to the endocardium of the heart, where its internal battery paces the heart for years. It’s certainly an incredible piece of technology, but a high school student had a wild idea of testing whether such a fine piece of electronics can withstand a flight into space. Thankfully NASA has a sounding rocket program that flies small experiments to a high altitude but still below orbit, allowing all sorts of things to be tested. The Micra flew on a 36-foot long Terrier-Improved Orion rocket and reached 73 miles above Earth during a 13 minute flight. Following the mission, the device was run through a regular series of tests all of which checked out. This is pretty good news, but more tests are still going to be conducted to see if there was any damage to the Micra during flight. Here’s a video from Medtronic about this historic flight: Flashbacks: Medtronic’s Tiny Micra Pacemaker Going on a Space Flight…; Medtronic Introduces Micra, World’s Smallest Pacemaker…; Medtronic’s Tiny Micra Leadless Pacemaker Approved in U.S…; Medtronic Micra, World’s Smallest Pacemaker That Lives Inside Heart, Cleared in Europe…; World’s Smallest Endocardial Pacemaker Getting Implanted in Initial Set of Patients… Via:...