Here’s a roundup of recent clinical trial news:
- Tryton wins conditional IDE nod for side branch stent trial
Tryton Medical Inc. announced Food & Drug Administration conditional approval of an investigational device exemption application to initiate a pivotal trial to evaluate the Tryton side branch stent system for coronary artery disease.
- Stentys launches large-scale, “real life” study of self-apposing stent in heart attacks
Stentys SA (EPA:STNT) announced that it has begun the international Apposition III study of its self-apposing stent, with 50 of 500 patients enrolled. The trial primary endpoint is major adverse cardiac events at 12 months post-procedure.
- Arterial Remodeling Technologies releases data on bioresorbable stent
Arterial Remodeling Technologies disclosed new data related to its bioresorbable stent platform — additional data that further validates the company’s innovative approach to simultaneously balance biocompatibility, biomechanics and bioresorption within a bioresorbable PLA (polylactic acid) stent. The new data show that the ART stent scaffold can be overinflated by more than 25 percent without cracking or crazing, and is thus designed to avoid the serious problem of malapposition associated with other bioresorbable stents that was documented at TCT 2010.
- St Jude touts results from Angio-Seal study
St. Jude Medical Inc. (NYSE:STJ) commends the efforts of the investigators in the Cirse vascular closure device registry, the world’s first multicenter registry aimed at assessing the performance of vascular closure devices in interventional radiology procedures.
- Boston Scientific touts publication of Altitude patient management system analysis
Boston Scientific Corp. (NYSE:BSX) welcomed the publication of an analysis from its Altitude clinical science program in the current issue of Circulation that showed patients followed by the Latitude patient management system experienced a 50 percent relative reduction in the risk of death compared to patients followed in-clinic only. The analysis also showed that heart failure patients who transmitted weight and blood pressure data via the Latitude system experienced an additional 10 percent reduction in the risk of death compared to other CRT-D patients followed by the Latitude system.
- InfraReDx touts case report on LipiScan coronary imaging system
InfraReDx Inc. announced the publication of a case report in Circulation describing the association of stent thrombosis with lipid core plaque as detected by its LipiScan coronary imaging system. The LipiScan is the first and only FDA-approved system to provide a Chemogram (map of lipid core plaque) within the imaged vessel via near-infrared spectroscopy. The authors note that the case represents the first demonstration of acute stent thrombosis associated with disrupted lipid core plaque as detected by NIR imaging with the LipiScan system.
- World Heart touts Levacor VAD safety data
World Heart Corp. (NSDQ:WHRT) announced that an investigator-initiated study that includes patients who had received the Levacor ventricular assist device was the subject of a presentation in the Emerging New Technologies Section at the Fifth European Mechanical Circulatory Support Summit. Preliminary clinical data suggests that the Levacor VAD does not cause acquired von Willebrand Factor deficiency, a condition that is linked to serious bleeding disorders and that has been associated with the use of current VADs.
- Bioheart plans LVAD/stem cells clinical trial
Bioheart Inc. (OTC:BHRT) announced the formation of a working group focused on adavancing a bridge-to-recovery clinical trial combining a left ventricle assist device and Bioheart’s MyoCell adult muscle stem cell composition and needle tipped catheter delivery system.
- Studies highlight role of stem cell transplants for blood cancers
Results from four innovative studies help answer outstanding questions about stem cell transplant procedures in treating various hematologic malignancies. Research presented at the 52nd Annual Meeting of the American Society of Hematology reveals that there is no increase in overall cancer risk in people who donate stem cells and that the utilization of a double cord blood stem cell transplant is associated with better overall outcomes when used early in the treatment of acute leukemias. While research shows that the use of an allogeneic stem cell transplant following an autologous stem cell transplant does not improve progression-free survival in patients with standard risk multiple myeloma, scientists have found a promising new treatment that may help prevent chronic graft-versus-host disease, a serious complication of stem cell transplantation.
- Tengion presents new large animal data
Tengion Inc. (NSDQ:TNGN) announced that data from its Neo-Kidney Augment, Neo-GI Augment and Neo-Urinary Conduit programs are being featured in several posters and oral presentations at the TERMIS North America annual meeting. Key data featured include the first presentations on the Neo-Kidney Augment mechanism of action, product formulation, and additional efficacy data from an ongoing study in a large animal model demonstrating the ability of the Neo-Kidney Augment program to improve kidney function in animals at risk of kidney failure. Additional new data are being presented demonstrating that the technology used with the Neo-Urinary Conduit can be successfully applied to stimulate regeneration of gastrointestinal tissue based on proof-of-concept studies for the Neo-GI Augment program.
- Lumalier Corp. touts study of automated UV-C device
Results of an eight-month hospital study, “Room Decontamination with UV Radiation,” were published in the October 2010 issue of Infection Control and Hospital Epidemiology. The study evaluated the ability of an automated UV device, Tru-D, to decontaminate patient rooms contaminated with MRSA, VRE, C. difficile and an MDR strain of Acinetobacter baumannii.
The research team of William Rutala, Maria Gergen, and Dr. David Weber conducted the study at University of North Carolina Health Care from Jan. 21 through Sept. 21, 2009.
- News From the 96th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA) in Chicago
Screening tool may better identify heart disease in African-Americans Researchers from the Medical University of South Carolina say they may have an explanation as to why African Americans, despite having lower amounts of coronary artery calcification, are at increased risk for heart attacks and other cardiovascular events, compared with Caucasians.
People with sleep apnea at higher risk for aggressive heart disease
People with obstructive sleep apnea, a sleep disorder associated with obesity, have more non-calcified plaque in their coronary arteries, putting them at increased risk for developing an aggressive form of atherosclerosis, according to a study from the Medical University of South Carolina.
Researchers use patient’s own blood to treat hamstring injury
Researchers from Royal National Orthopaedic Hospital in London say they have found an effective treatment for microtears in the hamstring: injections of the patient’s own blood and a steroid along with “dry-needling,” in which repeated needle punctures cause controlled internal bleeding to promote healing in the injured area.
Belly fat puts women at risk for osteoporosis
For years, it was believed that excess body fat protected against bone loss. But a new study from Massachusetts General Hospital says that women with too much belly fat may be putting their bones at risk.