Contrast in Medical Technology

PLC Systems Receives Full FDA Approval for Pivotal Study of RenalGuard(TM) in The U.S.

... interventional procedures that use radiographic contrast media. The Company's U.S. pivotal study, under ... allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. ... patients undergoing imaging procedures using contrast media. About PLC Systems Inc. ...

NicOx Announces Favorable Blood Pressure Data for Naproxcinod in a Large ABPM Study

... (p=0.011) compared to naproxen. Furthermore, in contrast to naproxen, naproxcinod reduced the mean 24-hour ... for naproxcinod across the dose range, in contrast to naproxen. In addition, the use of the ABPM ... in the mean 24-hour SBP and DBP from baseline in contrast to naproxen. In terms of the overall treatment ...

PLC Systems Defers Pivotal Study of RenalGuard(TM) in the U.S.

... stents. It is believed that allowing contrast media to dwell in the kidneys can lead to CIN. By ... enabling the body to more rapidly void the contrast media, thereby reducing its overall resident time ... interventional procedures that use radiographic contrast media. Approximately seven million patients ...

PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)

... is a risky complication resulting from the use of contrast media for coronary and peripheral vascular ... the body to rapidly eliminate toxins in contrast media, reducing their harmful effect. RenalGuard ... patients undergoing imaging procedures using contrast media. In the U.S., PLC recently completed a ...

PLC Systems Receives FDA Approval to Commence Pivotal Study Of RenalGuard(TM) In the U.S.

... the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard ... patients undergoing imaging procedures using contrast media. About PLC Systems Inc. PLC Systems ... designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is ...

PLC Medical Systems Names Lead Investigators for Pivotal Trial to Evaluate RenalGuard System(TM) and RenalGuard Therapy(TM)

... RenalGuard(TM) in preventing contrast -Induced Nephropathy FRANKLIN, Mass., Dec. 19 ... allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. The ... patients undergoing imaging procedures using contrast media. PLC conducted a pilot study to confirm ...

Unique Cardiovascular Treatment Readied for Global Market: Proprietary Paccocath(R) Technology is the Only Drug Eluting Balloon with Clinical Data

... recently merged with MEDRAD, the leader in diagnostic and interventional contrast injection. Together, they have formed MEDRAD Interventional / Possis, a ... Avanta(R) Fluid Management Injector Systems, Mark V ProVis(R) Angiographic contrast Injectors, the GuardDOG (R) Occlusion System, FETCH(R) Aspiration ...

YM BIOSCIENCES ANNOUNCES NIMOTUZUMAB PRESENTATIONS TO BE MADE AT THE 100TH ANNUAL MEETING OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH AND EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY

... being reported independent of the KRAS status of patients, are in sharp contrast to the dated speculation that toxicity is a marker for efficacy of ... confer a wide therapeutic window compared to Erbitux(R) and thus, in contrast to it, nimotuzumab is a more precisely targeted therapy. The AACR ...

Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

... prevents the anthrax toxins from entering and killing the cells. In contrast to the anthrax vaccine, the protection afforded by a single dose of ... the rapid achievement of appropriate blood levels of ABthrax. In contrast to antibiotics, ABthrax acts against the deadly toxins produced by anthrax ...

Breast MRI Scan Could Determine Need for Radiation Therapy

... tumors and tumors that have not spread to the lymph nodes, he said. A contrast dye used routinely in MRI scans not only highlights the size and location ... the blood vessels feeding the tumor. The kinetics or activity of the contrast dye in the tumor provided some key parameters for comparing MRI to ...

PLC Systems Reports Fourth Quarter 2007 Results

... System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that ... urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement ...

New Approach to Treating Anthrax Significantly Improves Survival Rates in Pivotal Efficacy Studies

... for its use in the treatment of inhalational anthrax disease. In contrast to the anthrax vaccine, the protection afforded by a single dose of ... following the rapid achievement of appropriate blood levels of ABthrax. In contrast to antibiotics, ABthrax acts against the deadly toxins produced by anthrax ...

PLC Systems Achieves Successful Early Conclusion of RenalGuard(TM) Pilot Safety Trial

... System. RenalGuard Therapy is designed to reduce the toxic effects that contrast media can have on the kidneys. This therapy is based on the theory that ... urine output is beneficial to patients undergoing imaging procedures where contrast agents are used. The real-time measurement and matched fluid replacement ...

American Meat Institute Calls WCRF Panel Recommendations on Meat Consumption Extreme and Unfounded

... Says Alarmist Messages Reflect Group's Anti-Meat Bias, Stand in Sharp contrast to U.S. Dietary Guidelines and Plain Common Sense WASHINGTON, Oct. 31 ... time after time." Huffman stressed that the recommendations stand in sharp contrast to mainstream advice in the U.S. Dietary Guidelines. The causes of ...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

... study results provide the first prospective clinical validation of neurogenesis as a target for the treatment of mood disorders like depression, in contrast to the traditional focus on affecting serotonin function for antidepressant drug development," said lead investigator Maurizio Fava, M.D., vice ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... BLOOM-DM all patients will receive echocardiograms at baseline, at month 6, and at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an ...

Medivation Announces Positive New Efficacy Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients

... Cancer Center in New York. "These findings suggest that MDV3100, with its unique mechanism of action, provides beneficial clinical effects in contrast to those achieved with first-generation androgen receptor antagonists." In vitro data recently published in Science provide evidence that ...

Essentialis Meets Primary Endpoint in Phase 2b Trial of DCCR for Treatment of Hypertriglyceridemia and is Granted Extensive Patent Coverage in the US

... approved drugs. In subjects with very high baseline triglycerides, DCCR treatment resulted in a substantially greater reduction in triglycerides. In contrast to the effects of Lovaza and fenofibrate - the current gold standard medicines for treating hypertriglyceridemia - no meaningful increase in LDL-C ...

PLC Medical Systems to Demonstrate RenalGuard(R) at EuroPCR 2009

... the current clinical trial in Italy and the planned future U.S. clinical trial for RenalGuard as a safe and effective prevention device for contrast induced nephropathy may not be completed in a timely fashion, if at all, or, if these clinical trials are completed, they may not produce clinically ...

Boston Scientific Data Show Real-World Survival Rates for Implantable Cardiac Device Patients Exceed Rates From Clinical Trials

... survival rates for ICD patients of up to 92 percent Five-year survival rates for CRT-D patients of up to 78 percent "In contrast to clinical trials, the ALTITUDE program analyzes device therapy in real-world practice and offers insights into clinical event rates and disease ...

Autism Studies Presented at Mid-Atlantic Research Consortium Meeting

... are asked to complete tasks that involve memory and organization. Different brain regions were active in children with high-functioning autism, in contrast to brain activity in "neurotypical" children -- those without autism or other neurological disorders. Robert Schultz, Ph.D., director of the Center ...

Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers

... foot ulcers in patients with type I or type II diabetes. Excellarate is designed to require only one or two physician-administered treatments, in contrast to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months). (Logo: ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... arm was 36 percent (n=21/59) compared to 50 percent for a 48-week control arm with PEGINTRON and standard-dose REBETOL plus boceprevir (n=8/16). In contrast to the results seen in Part I, the low-dose REBETOL regimen was associated with increased viral breakthrough during treatment, higher relapse rates ...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... and decreased across all treatment groups by approximately -0.25 points. The results from both of these two exploratory scales are in direct contrast to the statistically significant results of the validated PGIC and EHP-5 pain dimension. To better understand this observation, we examined ...

Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State

... syndromes. A positive result may be confirmed using a fluorescence in situ hybridization (FISH) methodology. aCGH technologies compare and contrast a specimen's DNA to the DNA of a healthy individual to identify, at a high resolution, extra or missing genetic material in the specimen. These ...

FDA Submission of B-R-A-H-M-S MR-proANP Kryptor

... is unstable, the B-R-A-H-M-S-assay detects the corresponding prohormone fragment: the Mid-Regional pro-Atrial Natriuretic Peptide (MR-proANP). In contrast to the mature peptide, MR-proANP is a stable and reliable surrogate measurement of atrial natriuretic peptide levels. The clinical benefits of ...

Novavax Reports Positive Preclinical Results for a Novel, Broadly Cross-Protective H5N1 Pandemic Influenza Virus-like Particle (VLP) Vaccine Candidate

... with lethal doses of three different H5N1 strains including A/Indonesia (Clade 2.1), A/Qinghai (Clade 2.2), and A/Shenzhen (Clade 2.3.4) in contrast to unimmunized controls. The vaccine candidate also induced robust antibody responses against several H5N1 strains as demonstrated by ...

Cloned Human Embryos Successfully Reprogrammed Using Human - But Not Animal - Eggs

... clones) and human-to-animal clones (hybrids) appear similar, the pattern of reprogramming of the donor human cell is dramatically different. In contrast to the human-animal hybrids, the gene expression pattern of the human clones was highly similar to normal human embryos. The paper is available free ...

Jennerex Treats First Patients in Phase 2 JX-594 Trial for Liver Cancer

... mechanism of action and the results in patients to date put the company's product class in a leadership position. Jennerex's position is in marked contrast to gene therapy and standard cancer vaccine approaches. For more information about Jennerex and the company's robust pipeline and three ...

Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic in Acute Post-Operative Pain

... dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Oral bioavailability was confirmed in multiple species. In contrast to currently marketed opioids, CR845 did not produce inhibition of intestinal transit (ileus) or elicit signs of abuse or addiction liability in ...

Circassia Completes Patient Recruitment for Phase II Clinical Trial of Toleromune(R) Allergy Treatment

... study is comparing several different ToleroMune treatment regimens, each with standardised doses administered over several weeks. This is in sharp contrast to most current allergy immunotherapies, which can require carefully titrated dosing over many months and even years. As part of the ongoing study, ...

NicOx' Naproxcinod Shows Robust Blood Pressure Results in Phase 3 Pooled Analysis

... naproxcinod 375 mg bid (p=0.013) and placebo (p<0.001). Both naproxcinod doses showed a similar blood pressure profile to placebo, in contrast to naproxen which raised SBP (p<0.001) There is a clear unmet medical need for a novel anti-inflammatory agent with no detrimental impact ...

Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders

... median platelet counts were 16,000 microliters in both groups, platelet counts never exceeded 30,000 microliters in the placebo group. This is in contrast to median platelet counts rising to 36,000 microliters in the eltrombopag group after one week of treatment and ranging from 52,000 to 91,000 ...

Third Pivotal Phase 3 Study for NicOx' Naproxcinod Shows Positive Efficacy, Safety and Blood Pressure Results

... 500 mg bid. There was not a single serious cardiovascular or serious GI adverse event in the naproxcinod arm during the 13 weeks of the 303 study, in contrast to the placebo and naproxen 500 mg bid arms. Pascal Pfister MD, Chief Scientific Officer and Head of Research and Development at NicOx, ...

Trellis(R) Peripheral Infusion System Removes Blood Clots in Largest Reported Prospective Endovascular DVT (Deep Vein Thrombosis) Patient Series

... around 20 minutes. No follow-up monitoring in a costly critical care or intensive care unit was typically needed with the Trellis System, in contrast to this requirement of CDT procedures. There were no reported bleeding complications related to the Trellis device in acute follow up and the ...

Vascular Surgeons Agree: Case Rehearsal Improves Outcomes

... the operative flow, increased patient safety and efficiency of instrument use, decreased overall operative and fluoroscopy time and the amount of contrast used, and that the operative and simulator outcomes were similar. An abstract of the study is provided below: Patient Specific Case Rehearsals ...

Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus

... mechanism of action and the results in patients to date put the company's product class in a leadership position. Jennerex's position is in marked contrast to gene therapy and standard cancer vaccine approaches. For more information about Jennerex and the company's robust pipeline and three ...

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A

... Journal of Medicine(2), include: -- 93 percent of the participants in the routine prophylaxis group showed normal joint function, in contrast to 55 percent in the episodic group. -- Kogenate FS prophylaxis treatment was able to preserve the joint even if the child had less than or ...

NeoVista Unveils 18-month Data on Novel Wet AMD Therapy at Retina Society Meeting

... current standard of care," said Dr. Sabates. "It's highly encouraging to continually see patient outcomes improving as the study progresses." In contrast to other forms of radiation therapy for wet AMD, NeoVista's approach delivers the peak dose of energy directly to the lesion without damaging the ...

StemCor Systems Receives CE Mark for MarrowMiner(TM) System for Bone Marrow Collection

... shaft gains access to the bone marrow cavity through the access guide to allow the removal of bone marrow through a single entry site. This is in contrast to the current practice of bone marrow aspiration through the insertion of a needle into multiple sites in the iliac crest of the hip, which usually ...