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Fujifilm Medical Systems showcased a 3D advanced visualization package called Synapse 3D for integration into its Synapse cardiovascular informatics portfolio, at the 59th annual American College of Cardiology (ACC) Scientific Session in Atlanta this week.
Medical device developer Teleflex Medical has issued a voluntary recall of the Arrow Select IV Tubing sets, accessories and certain lots of arterial embolectomy catheters after it discovered faults with the product's sterility.
Interventional radiologists have found that a subgroup of patients with critical limb ischemia, the most severe form of peripheral arterial disease (PAD), may avoid amputation through the use of drug-eluting stents on the smaller arteries below the knee, according to a study released at this week’s Society of Interventional Radiology's (SIR) Annual Scientific Meeting in Tampa, Fla.
Written by Justine Cadet
ATLANTA—Lowering blood pressure to below currently recommended levels did not significantly reduce the combined risk of fatal or nonfatal cardiovascular disease events in adults with type 2 diabetes who were at especially high risk for cardiovascular events, based on the ACCORD trial presented at the American College of Cardiology (ACC) conference today. Slides»
The FDA has approved Boston Scientific's Express LD, a premounted, balloon-expandable stent specifically for use in iliac arteries. The company said it plans to launch the product immediately in the U.S.
Use of the Mo.Ma proximal cerebral protection device (Invatec) with FDA-approved carotid stents in high-risk patients are 98 percent effective and proved to decrease the risk of stroke, according to results of the ARMOUR trial presented by Barry T. Katzen, MD, at the 35th annual Society of Interventional Radiology Scientific Meeting March 15.
The FDA has added a boxed warning to the label for clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Aventis), the most widely sold anti-clotting medication, for patients who do not effectively metabolize the drug (i.e., poor metabolizers) and therefore may not receive the full benefits of the drug.
Tuesday, March 09 2010
Rcadia Medical Imaging has been issued a CE Mark for its computer-aided detection software--the COR Analyzer system--that helps identify patients with significant coronary artery disease by an analysis of coronary CT angiography (CCTA) studies.
The FDA has snubbed Forest Laboratories' Supplemental New Drug Application submission that would have indicated nebivolol (Bystolic), currently approved for the treatment of hypertension, as an additional treatment for chronic heart failure (HF).
The Department of Justice (DoJ) has charged Guidant, a wholly-owned subsidiary of Boston Scientific, with covering-up device failure problems associated with its Ventak Prizm 2 DR and Contak Renewal implantable cardioverter-defibrillators (ICD).
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Boston Scientific announced the completion of patient enrollment in the small vessel and long lesion trials of its PLATINUM clinical program during the American College of Cardiology (ACC) conference in Atlanta this week. The trials are designed to compare the platinum chromium Promus Element everolimus-eluting stent to matched historical control groups of patients treated with the Taxus Express paclitaxel-eluting stent.
Medtronic has commenced an international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.
Written by Gina Narcisi
ATLANTA--Currently, cardiovascular imaging accounts for 30 percent of all the medical radiation that people receive in the U.S., noted Andrew Einstein, MD, cardiologist and assistant professor of clinical medicine at Columbia University College of Physicians and Surgeons in New York City, during a symposium at the 59th annual American College of Cardiology (ACC) annual conference on Monday. Einstein also spoke to whether the current levels of radiation are appropriate, as well as strategies for reducing radiation exposure.
St. Jude Medical has received FDA clearance and European CE Mark approval for the Engage and Engage TR sheath introducers.
The field of electrophysiology (EP), particularly pertaining to ablations, has been reported to be growing faster than coronary interventions, and there are no signs that it will slow down. While the volume of coronary cath procedures has remained somewhat flat over the past year, EP labs have been expanding and adding new technology. For this reason alone, it behooves attendees at ACC.10, which begins on Saturday, March 13, to take in some of the exciting EP lectures being presented at the conference.
One of the biggest topics in EP is whether transcatheter ablation should be the first-line treatment over anti-arrhythmic drugs in patients with atrial fibrillation (AF). First results of the pilot CABANA study, being released in a late-breaking clinical trial session, could potentially indicate a new direction for this debate (see below for session details).
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The FDA has warned healthcare professionals of a class 1 recall regarding the Baylis Medical Torflex Transseptal Guiding Sheath after it found that the sheath tip has the potential to break off and separate during cardiac procedures.
Two companies that make surgical ablation devices have settled whistleblower lawsuits with the government that alleged they marketed the devices for the treatment of atrial fibrillation (AF), which is not an FDA-approved indication, according to a report in the March 11 Wall Street Journal.
SynCardia’s wearable Freedom driver system that allows patients implanted with its CardioWest Total Artificial Heart to be home while awaiting a matching donor heart has received the CE mark of approval for distribution across Europe.
GlaxoSmithKline (GSK) has released a 30-page white paper refuting that the recent U.S. Senate report on its diabetes drug Avandia failed “to present an accurate, balanced or complete view of the currently available information on Avandia (rosiglitazone).”
Written by Justine Cadet
As clinical trial data have shifted toward favoring second-generation drug-eluting stents (DES), the market has trended in a similar direction. In addition, the overall positive results with most DES have emboldened physicians to use them for more complex disease states, including left main disease—to the dismay and excitement of many.
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Middle age introduces itself in many ways; one is atrial fibrillation (AF). My onset of AF seems to have coincided with a mountain bike accident in the woods of North Carolina that resulted in some cracked ribs.
The use of health IT to reduce rehospitalizations will be welcome but also disruptive, said Stephen Jencks, an independent consultant in healthcare safety during a Feb. 24 webinar on the potential use of health IT to mitigate rehospitalizations, sponsored by the Agency for Healthcare Research and Quality (AHRQ).