Updated: 3/7/2011 9:45 a.m.
Medtronic Inc.’s (NYSE:MDT) clinical trial for its CoreValve transcatheter aortic valve implant system has officially begun.
The 40-site, 1,300-patient trial is designed evaluate a the non-surgical alternative to open-heart surgery for patients with severe aortic stenosis.
The Detroit Medical Center Cardiovascular Institute completed the first two transcatheter aortic valve implants ever achieved in Michigan as part of the medical center’s participation in the CoreValve clinical trial. Atlanta’s St. Joseph’s Hospital will also be one of 40 hospitals to will take part in the trial.
Medtronic in February announced results from a European study on the CoreValve device, which won CE Mark approval in 2007.* The Minneapolis-based medical device giant said the findings from a study published in Circulation confirmed both early and sustained clinical benefits for patients receiving the CoreValve system for the treatment of aortic valve disease.
The company was also in February given the go-ahead to produce the CoreValve device in the U.S. despite suffering a $74 million patent infringement judgment related to the device. Judge Gregory Sleet of the U.S. District Court for Delaware shot down a motion filed by valve maker Edwards Lifesciences Inc. (NYSE:EW) seeking an injunction against Medtronic manufacture and sale the CoreValve device. Edwards said it will appeal.
Here’s a roundup of recent clinical trial and scientific study news:
- Study associates
more plaque build-up with drug-eluting over bare-metal stents
New pathological evidence assessing the vascular response to stent implantation shows that atherosclerosis develops within the neointima more frequently and earlier in patients treated with a drug-eluting stent compared with those who receive a bare-metal stent, writes heartwire. The findings were published in the Journal of the Amerian College of Cardiology in a study titled "The Pathology of Neoatherosclerosis in Human Coronary Implants."
- Miracor touts PICSO clinical trial
Miracor Medical Systems GmbH completed the pilot study of its PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) system, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI). The “Prepare PICSO” pilot study of stable angina patients included ten (10) patients of principal investigator Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, The Netherlands. It is planned that Miracor will now initiate the pivotal RAMSES clinical trial of PICSO. Timely myocardial reperfusion using primary percutaneous coronary intervention (PCI) remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI).
- Protein could be new target to reduce damage after heart attacks
Scientists identified a protein that plays a key role in debilitating changes that occur in the heart after a heart attack, according to research reported in Circulation Research: Journal of the American Heart Association. These changes, or "remodeling" of the heart, often lead to fatal heart failure. The findings suggest a possible future therapy for preventing or reducing heart muscle damage after a heart attack. Researchers compared the effect of heart attacks in two groups of mice. One group was genetically engineered to lack fibronectin-EDA (FN-EDA), a protein that exists in the space surrounding cells and is important for processes such as cell migration and wound healing. The other mice were genetically normal.
- ACD touts RNAscope clinical study results
Advanced Cell Diagnostics, Inc. announced the results of its clinical study utilizing RNAscope technology to detect human papillomavirus (HPV) E6/E7 mRNA in routine clinical specimens of head and neck cancer. HPV status determined by the RNAscope HPV test was highly predictive of patient outcome and highly concordant with that determined by existing methods. Significantly, the RNAscope test under development demonstrated 16 percent higher detection sensitivity than the HPV DNA test used in the study.
*Correction, March 7, 2011: This article originally stated that the European study was a segment of an overall clinical trial for the CoreValve system. This is not the case. The European study was independent from the U.S. trial. Return to the corrected sentence.