Corindus Vascular Robotics began the clinical trial of its CorPath 200 system for placing coronary stents with a pair of procedures in New York and Boston.
The Natick, Mass.-based company said the first procedures in the 154-patient trial, called the Percutaneous Robotic-Enhanced Coronary Intervention Study, were performed at New York-Presbyterian Hospital/Columbia University Medical Center in New York and St. Elizabeth’s Medical Center in Boston.
The prospective, single-arm, multi-center study will be conducted at sites across the U.S. including New York-Presbyterian/Columbia, St. Elizabeth’s Medical Center, Virginia Commonwealth University Medical Center in Richmond, Va., St. Joseph’s Hospital Health Center in Syracuse, N.Y., and Swedish Medical Center in Seattle. The results will form the basis for an application for 510(k) clearance from the FDA.
Here’s a roundup of other recent clinical trial and scientific research news:
- Taris Biomedical launches Phase Ib trial of drug-device combo for bladder disease
Taris Biomedical initiated a Phase 1b clinical study in patients with interstitial cystitis to evaluate the safety and tolerability of its Liris drug-device combination in patients suffering from moderate-to-severe IC. The device is designed to continuously deliver lidocaine over an extended period directly to the bladder to decrease symptoms associated with IC, such as bladder pain and voiding dysfunction.
- AccessClosure touts Mynx vascular sealing results
AccessClosure Inc. announced results from a study in the Journal of NeuroInterventional Surgery comparing the pain associated with its vascular closure device, the Mynx 5F, and Angio-Seal’s Evolution device. The single-blinded, randomized, single-center, controlled trial showed that pain at closure and the pain increase from baseline to closure were significantly higher in patients treated with the Angio-Seal device, with no difference in the rate of closure success or closure complications between the devices.
- Bone lazy: Study shows that osteoblasts need “Frizzled-9” for bone growth
New research in the Journal of Cell Biology shows that the Wnt receptor Frizzled-9 promotes bone formation, providing a potential new target for the treatment of osteoporosis.
- Low-radiation alternative to CT angiography shows promise
A technique called prospective ECG gating, in which radiation is only applied at a predefined point in the cardiac cycle, can reduce the radiation dose during procedures by up to 80 percent. But whether this test performs as well as angiography in diagnosing disease is uncertain.
- Adoption of newer, more expensive prostate cancer treatments increasing, says study
New research from the Dana-Farber/Brigham and Women’s Cancer Center in Boston shows that newer, more expensive treatment options for prostate cancer were adopted rapidly and widely between 2002 and 2005 — without proof of their cost-effectiveness. Maybe that’s why health care spending accounts for 17 percent of the nation’s GDP.
- Vertos Medical presents one-year data on Mild lumbar stenosis treatment
Vertos Medical Inc. released data from a pair of studies of its Mild treatment for lumbar spinal stenosis showing its long-term safety and efficacy and “superior durability” over epidural steroid injections.
- SuperSonic Imagine presents European data on breast cancer treatment
SuperSonic Imagine presented data from a study of its ShearWave Elastography technology in conjunction with ultrasound for detecting breast cancer lesions.
- Celleration releases Mist deep-tissue bedsore treatment results
Celleration Inc. released clinical results for its Mist ultrasound healing therapy for deep tissue injuries, a form of pressure ulcer or bedsore.
- Freedom Meditech touts non-invasive, light-based glucose monitor
A study published in the March issue of the Journal of Diabetes Science and Technology comparing the direct measurement of glucose using Freedom Meditech’s optical polarimetry technology and blood glucose samples “provides a basis for the development of a noninvasive polarimetric glucose monitor for home, personal, or hospital use,” according to the journal.
- Cerebrospinal fluid’s role in brain stem cell development
Cerebrospinal fluid, found in and around the brain and spinal cord, may play a larger role in the developing brain than previously thought, according to a report in the journal Neuron. Researchers at Children’s Hospital Boston also identified a CSF protein whose levels are elevated in patients with glioblastoma, a common malignant brain tumor, suggesting a potential link between CSF signaling and brain tumor growth and regulation.
- Avinger closes enrollment in CONNECT trial
Avinger Inc. completed enrollment in its Connect (chronic total occlusion crossing with the Wildcat catheter) clinical trial, a prospective, multi-center, non-randomized study to evaluate its ability to cross chronic total occlusions in femoropopliteal lesions.
- Lantheus wins special protocol assessment approval for Phase 3 trial of Flurpiridaz F-18
Lantheus Medical Imaging Inc. announced an agreement with the FDA on the design and planned analysis of a Phase III clinical trial for the assessment of myocardial perfusion using PET imaging of flurpiridaz F-18 in patients with suspected or known coronary artery disease. Lantheus said plans to begin the first of two planned Phase III trials during the second quarter of 2011.
- Repligen releases Phase III trial results of synthetic MRI enhancer
Repligen Corp. (NSDQ:RGEN) reported positive top-line results from a Phase III study evaluating the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging of the pancreas in patients with pancreatic disease using endoscopy as a diagnostic reference.