Archives: 12/2010

impellaheartpump MINI AMI Study To Evaluate Impella 2.5 for Reduction of Infarct Size; Company Halts Other Trial
Abiomed‘s Impella 2.5 Percutaneous Circulatory Support System, the world’s smallest left ventricle heart pump, has received conditional approval from the FDA to begin MINI-AMI, “a prospective, randomized, controlled multi-site trial to assess the potential role of the Impella® 2.5 in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI).” As we have reported before, the device has already been approved by the FDA for use in patients for up to six hours, to augment cardiac output by as much as 2.5 liters per minute in patients with acute left ventricular failure, who are also suffering from ongoing acute MI.
More about the study:
4fdgd MINI AMI Study To Evaluate Impella 2.5 for Reduction of Infarct Size; Company Halts Other Trial

The primary objective of this study is to evaluate whether the adjunctive use of the Impella 2.5 for 24 hours following primary percutaneous intervention (PCI) for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care. According to the American Heart Association (AHA), 400,000 patients in the U.S. suffer from STEMIs every year.
“This pilot study will determine whether the Impella 2.5 can be the first device to actually shrink infarct size," said Principle Investigator Jeffrey Moses, M.D., New York-Presbyterian Hospital and Columbia University Medical Center. “Today, heart attack survivors can suffer considerable subsequent disability from damaged heart muscle. The intent of this study is to investigate the unique unloading capabilities of Impella 2.5 and its effect in potentially reducing infarct size and improving quality of life for patients.”
The primary endpoint of the study will be a cardiac MRI-assessed ratio of the final infarct area to the total area of myocardium that was at risk. This ratio will be measured at three to five days after treatment and then again at 90 days. A total of 50 patients at five hospital sites will be randomized to Impella 2.5 support or the institution’s standard of care with no circulatory support post-PCI. The study is based on the hypothesis that Impella’s ability to directly unload the left ventricle will reduce overall infarct area relative to the total area at risk which has been demonstrated in previous animal studies.
The MINI-AMI study will enroll patients with acute anterior STEMI or large inferior STEMI, primary PCI performed within five hours of the onset of symptoms, patients undergoing emergent primary PCI of one culprit lesion in one major coronary vessel, and successful revascularization of the native coronary artery at the end of PCI.

In other, more negative news, Abiomed has ended the Protect II trial of Impella 2.5, “based on a futility determination at the planned interim analysis regarding the primary end-point, which the company views as likely to be due to unanticipated confounding variables related to the use of rotational atherectomy,” according to a press release. In other words, the reason for suspension were unanticipated events that resulted from overtly enthusiastic cardiologists adding atherectomies to the angioplasty. The following was released by the company:

“Atherectomy was an unanticipated variable which resulted from the operators’ decision to ‘do more with Impella.’ Our investigators had unblinded knowledge of the treatment arm after randomization,” said William O’Neill, M.D., University of Miami and Principal Investigator of the PROTECT II study. “It is interesting that operators felt that they could do more complex interventions once randomized to Impella and this in and of itself is an important finding.”

More from MassDevice: Over-eager docs prompt Abiomed to halt Protect II trial …;
Dow Jones Newswires: Abiomed Ends Impella Study On Unanticipated Variable …
Press releases: Abiomed Receives Conditional FDA Approval for Study with Impella 2.5 in Reducing Heart Muscle Damage Following PCI in STEMI Patients…; Abiomed Ends Protect II Study and Announces Interim Results, Detailed Clinical Analysis to Be Presented at ACC 2011 …
Product page: Impella 2.5
Flashbacks: Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV; Impella Recover Devices Approved in Germany for Reimbursement

XiOhwer XiO Proton Therapy Planning Software Gets US Green LightElekta out of Stockholm, Sweden has received 510(k) clearance from the FDA for its XiO spot scan planning software for use in preparation for Intensity Modulated Proton Therapy. The software aims to make it easy and intuitive to plan the beam path and therapy dose delivered to the tumor.
Some details about the XiO software from the product page:

XiO supports a range of treatment modalities, including 2D, 3D, MLC-based IMRT, solid compensator-based IMRT and brachytherapy. Dynamic conformal arc therapy and stereotactic delivery also are supported.
With automated image fusion, XiO delivers rapid and reliable registration of multiple data sets. Automated contouring tools, including patented auto-segmentation functionality and powerful drawing and editing features, allow quick and easy identification and delineation of target volumes and critical structures.
* Broad Beam supports uniform scanning, wobbled beams and scattered beams. Spread-out Bragg Peak (SOBP) can be created via rotating wheels and ripple filters. Apertures and range compensators are supported
* Spot Scanning with Intensity Modulated Proton Therapy (IMPT) includes nuclear interactions, subspots, apertures and range shifters.

Press release: Elekta Receives FDA 510(k) Clearance for XiO Software to Plan Spot Scanning for Proton Therapy…
Product page: XiO …

7677iuur1 FDA Approves 60 Second HIV Test from bioLytical
British Columbia firm bioLytical™ Laboratories Inc. has received FDA approval for the company’s rapid HIV test, that has a reported minimum sensitivity and specificity of 99.8% and 99.5% respectively. According to the press release, the FDA approved INSTI™ Rapid HIV Test for the detection of antibodies to HIV-1 in whole blood, finger stick blood, or plasma specimens. The firm is still seeking US regulatory approval for HIV-2 detection.
More about the test:
7677iuur2 FDA Approves 60 Second HIV Test from bioLytical

INSTI includes a unique antigen construct comprised of recombinant proteins for HIV-1 (gp-41) and HIV-2 (gp-36). “These unique antigens ensure that the test will be a critical addition to any rapid testing algorithm,” said Rick Galli, bioLytical chief technical officer. As with all rapid HIV tests, positive results are considered preliminary and must be confirmed before establishing a diagnosis of HIV infection.
“The unique antigen is important because the HIV testing community appears to be headed toward a multi-rapid test algorithm, eliminating the need for the more costly and time-consuming Western Blot and Indirect Fluorescent Antibody (IFA) tests,” said Niel Constantine, Ph.D., professor of pathology, University of Maryland School of Medicine Institute of Human Virology, an INSTI clinical trial investigator. “Using a multi-test rapid algorithm, we must deploy tests with different antigens, so bioLytical’s use of a unique antigen satisfies that requirement. And since INSTI also utilizes a novel flow-through technology, it would be a strong addition to a rapid/rapid algorithm."
INSTI also includes a unique, enhanced procedural control, utilizing a true human IgG sample addition feature. The test will only react when the correct quantity of human blood is added, reducing user error that can lead to inaccurate results. The test is highly stable and does not require refrigeration or specialized storage.

Press release: FDA Approves bioLytical Laboratories’ INSTI™ Rapid HIV Test …
Product page: INSTI™ HIV-1/HIV-2 Rapid Antibody Test …

5244gsfd MRI Used to Visualize Live Birth
At the Charité Hospital in Berlin, researchers have built a specialty MRI machine with enough space to fit a woman undergoing labor. The Local, a German newspaper in the English language, is reporting that the first images of a baby moving through the birth canal have been captured, and that the mother and child are doing just fine. The clinicians involved in the project hope to be able to study why some women end up requiring a Caesarian section, while others do not.
More at The Local: MRI scans live birth…

3wsfff Brain Map Activation Study Reveals Action of Brain During Hand Motion
Brain-computer interfaces may help the paralyzed in the future to regain the ability to move. By directly reading what the brain intends on doing, muscles can be activated via electronic stimulation. The idea sounds easy enough, but reading the brain requires the ability to interpret complex neural physiology in real time. Researchers at UC Santa Barbara have been using functional MRI to study how the precuneus region inside the parietal lobe is involved with hand motion, and discovered that the brain uses different maps when moving the hand toward visible objects than when reaching toward expected but unseen targets like an itch at the back of the head.

Two UCSB scientists studied the brains of 18 individuals who made 400 distinct arm reaches as they lay in an MRI scanner.
The current scientific view is that all reaching movements –– those directed to visual targets or toward one’s own body –– are planned using a visual map. "Our findings suggest otherwise," said Pierre-Michel Bernier, first author and postdoctoral fellow. "We found that when a target is visual, the posterior parietal cortex is activated, coding the movement using a visual map. However, if a movement is performed in darkness and the target is non-visual, the same brain region will use a fundamentally different map to plan the movement. It will use a body map."
The researchers measured the "Blood Oxygen Level Dependent Signal," or BOLD signal, when looking at the MRI brain images. BOLD is an indirect way of looking at brain activity at a millimeter scale. They also used a methodology called "repetition suppression." This is what makes the study novel, according to the authors, as it is one of the first to identify where these maps are nested in the human brain. "We are a leader in the use of repetition suppression," said Grafton [Scott T. Grafton, professor of psychology].
Repetition suppression relies on the fact that when a brain region is involved in two similar activities in a row, it is less active the second time around. The team was able to pinpoint the brain’s use of body maps versus visual maps by isolating the location in the brain where the responses were less active with repeated, similar arm reaches.

Press release: UCSB Scientists Report Study of ‘Brain Maps’ for How Humans Reach; Robotics and Machine-Brain Interface for Paraplegics May Benefit …
Abstract in Neuron: Human Posterior Parietal Cortex Flexibly Determines Reference Frames for Reaching Based on Sensory Context

j645dgr Universal Interconnects for Microfluidic Diagnostic DevicesMicrofluidic technology continues to hold the promise of bringing lab quality diagnostic tests to the point of care. One of the persistent difficulties in the field has been building interfaces between microfluidic chips and larger devices that have to interact with them. Researchers at UC Davis are now proposing a new standard, called “fit-to-flow” connectors, that promises to allow near universal interconnectivity of microfluidic chips and electronics that control them.
From the study abstract in Lab on a Chip:

In this paper, we present standardized adhesive-free microfluidic adaptors, referred to as Fit-to-Flow (F2F) Interconnects, to achieve reliable hermetic seal, high-density tube packing, self-aligned plug-in, reworkable connectivity, straightforward scalability and expandability, and applicability to broad lab-on-a-chip platforms; analogous to the modular plug-and-play USB architecture employed in modern electronics. Specifically, two distinct physical packaging mechanisms are applied, with one utilizing induced tensile stress in elastomeric socket to establish reversible seal and the other using negative pressure to provide on demand vacuum shield, both of which can be adapted to a variety of experimental configurations. The non-leaking performance (up to 336 kPa) along with high tube-packing density (of 1 tube/mm(2)) and accurate self-guided alignment (of 10 μm) have been characterized. In addition, a 3D microfluidic mixer and a 6-level chemical gradient generator paired with the corresponding F2F Interconnects have been devised to illustrate the applicability of the universal fluidic connections to classic lab-on-a-chip operations.

Image: The clear block to the right is the Fit-to-Flow connector, with a microfluidic chip inserted. Channels take red and blue fluid through the connector to the chip. USB flash drive shown for scale. (Tingrui Pan/UC Davis photo)
More from UC Davis: Printable version A ‘USB’ for medical diagnosis?
Abstract in Lab on a Chip: Fit-to-Flow (F2F) interconnects: Universal reversible adhesive-free microfluidic adaptors for lab-on-a-chip systems

3gbnn Blast Badge Warns of Unnoticed Shockwave Damage to Brain
Brain injuries are common in soldiers following explosions on the battlefield. In many cases, though, symptoms of concussion may not be noticed because they’re not acute enough and medics could be triaging only those who are clearly wounded. Clinical researchers and engineers at University of Pennsylvania have developed a small patch that can be attached to clothing or helmets that will change color following a strong enough shock, so it could be used as an indicator for proper and expedient care.

The badges are comprised of nanoscale structures, in this case pores and columns, whose make-up preferentially reflects certain wavelengths. Lasers sculpt these tiny shapes into a plastic sheet.
Yang’s [Shu Yang, PhD, associate professor of Materials Science and Engineering] group pioneered this microfabrication of three-dimensional photonic structures using holographic lithography. “We came up the idea of using three-dimensional photonic crystals as a blast injury dosimeter because of their unique structure-dependent mechanical response and colorful display,” she explains. Her lab made the materials and characterized the structures before and after the blast to understand the color-change mechanism.
"It looks like layers of Swiss cheese with columns in between," explains Smith [Douglas H. Smith, MD, director of the Center for Brain Injury and Repair and professor of Neurosurgery at Penn]. Although very stable in the presence of heat, cold or physical impact, the nanostructures are selectively altered by blast exposure. The shockwave causes the columns to collapse and the pores to grow larger, thereby changing the material’s reflective properties and outward color. The material is designed so that the extent of the color change corresponds with blast intensity.
The blast-sensitive material is added as a thin film on small round badges the size of fill-in-the-blank circles on a multiple-choice test that could be sewn onto a soldier’s uniform.
In addition to use as a blast sensor for brain injury, other applications include testing blast protection of structures, vehicles and equipment for military and civilian use.

Full story from UPenn: Color-Changing “Blast Badge” Detects Exposure to Explosive Shock Waves…

robodudes ReWalk Exoskeleton Going on Sale in January
UK’s Daily Mail is reporting that Argo Medical will soon be making available in the U.S. its ReWalk exoskeleton for people paralyzed in the legs. The device provides power and walking motion, but balance has to be maintained by using forearm crutches. The system was originally developed by Amit Goffer, an entrepreneur was was left paralyzed after a car accident in 1997.
From the Daily Mail:

The two stone 7lbs device, worn outside of clothing, consists of leg braces outfitted with motion sensors and motorised joints that respond to subtle changes in upper-body movement and shifts in balance.
After several years of clinical trials in Israel and the United States, units will go on sale in January to rehabilitation centres around the world.
A harness around the patient’s waist and shoulders keeps the suit in place, and a backpack holds the computer and rechargeable 3 1/2-hour battery.
When operated, it makes clanging robotic sounds, like the hero of the 1980s cult movie ‘Robocop.’


Product page: ReWalk …
Flashbacks: ReWalk Exoskeleton; Video of ReWalk Exoskeleton System
(hat tip: Gizmodo)

9023nj Coming Soon: Rapid Prion Detection for Medicine and AgricultureResearchers at the National Institute of Allergy and Infectious Diseases (NIAID) have developed a method that may finally speed up detection of prions, and help with making diagnoses earlier with a more sensitive test.
From abstract at PLoS Pathogens:

Here we describe an approach for estimating the relative amount of prions using a new prion seeding assay called real-time quaking induced conversion assay (RT-QuIC). The underlying reaction blends aspects of the previously described quaking-induced conversion (QuIC) and amyloid seeding assay (ASA) methods and involves prion-seeded conversion of the alpha helix-rich form of bacterially expressed recombinant PrPC to a beta sheet-rich amyloid fibrillar form. The RT-QuIC is as sensitive as the animal bioassay, but can be accomplished in 2 days or less. Analogous to end-point dilution animal bioassays, this approach involves testing of serial dilutions of samples and statistically estimating the seeding dose (SD) giving positive responses in 50% of replicate reactions (SD50). Brain tissue from 263K scrapie-affected hamsters gave SD50 values of 1011-1012/g, making the RT-QuIC similar in sensitivity to end-point dilution bioassays. Analysis of bioassay-positive nasal lavages from hamsters affected with transmissible mink encephalopathy gave SD50 values of 103.5-105.7/ml, showing that nasal cavities release substantial prion infectivity that can be rapidly detected. Cerebral spinal fluid from 263K scrapie-affected hamsters contained prion SD50 values of 102.0-102.9/ml. RT-QuIC assay also discriminated deer chronic wasting disease and sheep scrapie brain samples from normal control samples. In principle, end-point dilution quantitation can be applied to many types of prion and amyloid seeding assays. End point dilution RT-QuIC provides a sensitive, rapid, quantitative, and high throughput assay of prion seeding activity.

Full paper at PLoS Pathogens: Rapid End-Point Quantitation of Prion Seeding Activity with Sensitivity Comparable to Bioassays
Press release: NIH study suggests that early detection is possible for prion diseases…
Image: Colour-enhanced image of prion proteins (PrPSc) from an animal infected with scrapie. Credit: Wellcome Images