Here’s a roundup of recent clinical study and clinical trial news:
- Medtronic revises CoreValve pivotal trial
Medtronic Inc. (NYSE:MDT) today announced it has received conditional approval from the Food & Drug Administration to modify its CoreValve U.S. Pivotal Clinical Trial. In the revised design, the trial will assess the CoreValve System in extreme risk (i.e. inoperable) patients in a single arm study with a primary endpoint of all-cause death or major stroke within 12 months. Furthermore, the revision includes the evaluation of alternate implantation routes for delivering the transcatheter valve, such as the subclavian approach.
Read more - Neuros Medical Announces First Patient Feasibility Study Results
Neuros Medical, Inc., a medical device company announced today initial feasibility study results of their patented high frequency alternating current (HFAC) Nerve Block technology from their first patient. The study is a short-term, 30-day test per patient, focusing on chronic residual limb pain. Nearly one million patients suffer from chronic residual limb pain in the U.S.
Read more - Independent Clinical Research Confirms Clinical Efficacy and Cost-Effectiveness of the SurgiCount Safety-Sponge® System
Results of a multi-year, independent clinical research study on retained surgical sponges published in the February edition of The Joint Commission Journal on Quality and Patient Safety show that the institution implementing the SurgiCount Safety-Sponge® System eliminated the occurrence of retained surgical sponges and the costs associated with these preventable surgical errors.
Read more - Cook Medical Releases REFORM Clinical Trial Data On Its Stent To Treat Renal Artery Disease
Study investigators today reported initial data from Cook Medical’s REFORM clinical trial that is aimed at assessing the safety and effectiveness of the company’s balloon-expandable renal stent for the treatment of renal artery stenosis. The data, presented by Robert Bersin, M.D., at ISET 2011, reveal a nine-month primary patency rate of 89.5 percent and a 97 percent rate of successful delivery and deployment of the stent.
Read more - Cook’s Ongoing Drug-Eluting Peripheral Stent Trial Shows Consistent Outcomes Over 24 Months Compared to One-Year Data
An investigational drug-eluting stent (DES) from Cook Medical showed sustained primary patency at two years compared to data collected at one year in the device’s prospective, randomized study, according to data presented today at the ISET 2010 International Symposium on Endovascular Therapy. The data, compiled from 479 patients enrolled in a randomized controlled trial being conducted to obtain FDA PMA clearance for the device, showed that patients receiving the self-expanding nitinol stent, which is coated with the drug paclitaxel, had 83.1 percent primary patency after 12 months. When evaluated at 24 months, the patency rate for the 278 patients tested from that cohort was 74.8 percent.
Read more - Fresenius Medical Care Achieves Statistically Significant Improvement in Patient Survival and Hospitalization in CMS End-Stage Renal Disease Management Demonstration Project
Results from the Centers for Medicaid and Medicare Services’ End Stage Renal Disease (ESRD) Disease Management Demonstration Project have been presented by the independent evaluation contractor, Arbor Research Collaborative for Health, in a series of scientific abstracts and a comprehensive evaluation report. The ESRD DM Demonstration Project is a five-year demonstration project (2006 to 2010) conducted by CMS to test the impact of expanded integrated care approaches applied to the Medicare ESRD patient population.
Read more - Critical Diagnostics Announces Cardiac Biomarker ST2 Predicts Outcomes in Ambulatory Chronic Heart Failure Patients
Critical Diagnostics, the exclusive developer of the Presage® ST2 Assay, announces the publication of the Penn Heart Failure Study (PHFS) in an advance e-publication of the January 19, 2010 edition of Circulation: Heart Failure. The results of this study demonstrated that ST2 levels not only predict outcomes for ambulatory outpatients with chronic heart failure, they more effectively risk-stratify such patients.
Read more - U-M Researchers Find Indirect Path to Attack Breast Cancer Stem Cells
Scientists at the University of Michigan Comprehensive Cancer Center have identified a potential new way of attacking breast cancer stem cells, the small number of cells in a tumor that fuel its growth and spread. Researchers found that breast cancer stem cells are regulated by a type of cell derived from bone marrow, called mesenchymal stem cells. These cells are drawn from the bone marrow to the cancer and create a “niche” for the cancer stem cells, allowing them to replicate.
Read more - Two-Year ZILVER PTX Trial Results Show Drug-Coated Stents Keep Leg Arteries Open: Presented at ISET 2011
Drug-coated stents hold promise as a safe and lasting solution for the treatment of clogged leg arteries, suggest two-year results of the Zilver PTX Trial being presented at the 23rd annual International Symposium on Endovascular Therapy (ISET). Blocked leg arteries are a symptom of peripheral arterial disease (PAD), which affects 8 to 12 million Americans.
Read more - Stents Help Stroke Victims When Other Treatments Don’t, Research at ISET 2011 Shows
Stents can open up blocked brain arteries after other stroke treatments have failed, according to research being presented at the ISET. In research conducted at the Baptist Cardiac & Vascular Institute in Miami, stents were placed in the blocked brain arteries of 19 acute stroke patients who had not been helped by clot-busting drugs or clot-removal devices. The stents opened up the arteries in 18 of the 19 patients (95 percent), and this resulted in 12 (63 percent) who had minimal or no deficits. Five patients (26 percent) died from major strokes.
Read more - Controversial MS Treatment Lessens Fatigue, Research at ISET 2011 Shows
Multiple sclerosis (MS) patients may get some relief from severe fatigue from an experimental procedure to open blocked blood vessels in the chest and neck, suggests preliminary Stanford University research being presented at ISET. A year after doctors used either angioplasty or stents to open blocked veins of 30 MS patients, they suffered about half the fatigue, on average, than they had before the treatment, according to data being presented by Michael Dake, M.D., Thelma and Henry Doelger Professor in the Department of Cardiovascular Surgery at Stanford University School of Medicine in Stanford, Calif. Patients with the most common type of MS – relapsing-remitting – benefitted most.
Read more
