|
The FDA, in conjunction with GE Healthcare's subsidiary Thomas Medical Products, has issued a Class I recall of the SafeSheath CSG Coronary Sinus Guide Hemostatic Introducer System, placed into blood vessels to insert pacing or defibrillator wires with infusion sideport, due to the potential of the sheath tip to fragment and embolize inside the blood vessel during use, causing serious cardiac events.
A $3.5 million, three-and-a-half-year study, will gather data from 3,500 patients with implantable cardioverter-defibrillators (ICDs) to analyze the risks and benefits associated with ICDs in patients who are at risk of death from ventricular fibrillation.
The addition of rosiglitazone (Avandia from GlaxoSmithKline) to glucose-lowering therapy in people with type 2 diabetes does not increase the risk of overall cardiovascular morbidity or mortality compared with standard glucose-lowering drugs, according to the RECORD trial in the June 20 edition of the Lancet.
|
Randomized controlled trials (RCT), the gold standard for evidence-based management policies, have flaws that can lead to suboptimal practice recommendations, according to research published Feb. 2 in the Journal of the American College of Cardiology.
Compared with 6-F guides, PCIs performed with 7- and 8-F guides were associated with more contrast medium use, renal complications, bleeding, vascular access site complications and greater need for post-procedure transfusion. PCIs performed with 8-F guides were also associated with increased nephropathy requiring dialysis, in-hospital major adverse cardiac events, and mortality, according to a study in the July issue of JACC: Cardiovascular Interventions.
Boston Scientific has received FDA approval to market its Taxus Liberte Long paclitaxel-eluting coronary stent system, a drug-eluting stent (DES) designed for long lesions.
|