PLC Systems Inc. (OTC:PLCSF) announced that it will commence its pivotal U.S. trial for the RenalGuard contrast-induced nephropathy treatment.
CIN is a form of acute renal failure caused by exposure to contrast media agents during image-guided cardiology and radiology procedures.
RenalGuard’s U.S. trials have been stalled for years, which PLC officials attributed to a troubled economy and stalled funding.
"The product first started in clinical trials in 2006," CEO Mark Tauscher told MassDevice in 2009. "We were ready for a major U.S. clinical trial for RenalGuard when this little problem with the banks failing and the recession came along.”
Earlier this year the Franklin, Mass.-based company touted clinical data from Italian trials that showed that the RenalGuard system helped prevent contract-induced nephropathy and dialysis in patients with chronic kidney disease who need catheterization procedures.
Read our interview with PLC Systems CEO Mark Tauscher from June, 2009.
Here’s a roundup of recent clinical trial and scientific study news:
Rates of patients who return to the emergency room within one week of discharge are high and climbing, according to a new study from the Perelman School of Medicine at the University of Pa.
Researchers analyzed data from around 2.3 million emergency room visits between 2005 and 2008 and found that hospital re-admission rates for recently hospitalized patients increased for each year of the study. By 2008 rates had increased from 28.6 percent to 38 percent.
Admission rates for patients not recently hospitalized increased at a lesser rate, from 15.3 percent to 17.2 percent.
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German cardiac device maker Biotronik announced encouraging results from the first-in-man clinical trial of its hybrid Orsiro drug-eluting stent, which combines active and passive coating. The device’s PROBIO coating minimizes interaction between the metal stent and body tissue, and the BIOlute coating delivers a limus drug via bioabsorbable matrix.
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IDEV Technologies Inc. announced full enrollment for its FDA-approved trial evaluating its SUPERA stent system. The trial is a prospective, single-arm study of 258 patients at 49 U.S. sites, according to the release. The Webster, Texas-based company touted positive results from a European study in February.
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In men with chronic heart failure, cardiac resynchronization therapy (CRT) improves patients’ libido, erectile dysfunction, and sexual performance, according to a new study published in the journal Clinical Cardiology. CRT is a type of pacemaker that paces the right and left ventricle.
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