Interventional Cardiology

This cardiac subspecialty uses minimally invasive, catheter-based technologies in a cath lab to diagnose and treat coronary artery disease (CAD). The main focus in on percutaneous coronary interventions (PCI) to revascularize patients with CAD that is causing blockages resulting in ischemia or myocardial infarction. PCI mainly consists of angioplasty and implanting stents. Interventional cardiology has greatly expanded in scope over recent years to include a number of transcatheter structural heart interventions.

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FDA clears way for thoracic stent-graft

The FDA approved Bolton Medical’s thoracic stent-graft and delivery system as a treatment for thoracic aortic aneurysms and penetrating atherosclerotic ulcers.

New Volcano IVUS catheter nets clearance in U.S., EU

Volcano has received clearance to market its new Visions PV .035 digital IVUS catheter in both the U.S. and Europe. The intravascular ultrasound (IVUS) catheter is designed to image large vessels in endovascular procedures.

BMS forks over most Plavix, Avapro rights plus $80M to Sanofi

Sanofi and Bristol-Myers Squibb (BMS) have restructured their alliance following the loss of exclusivity of Plavix and Avapro/Avalide in many markets.

Temporary break in DAPT may not increase ischemic risk

is not uncommon for patients who receive drug-eluting stents (DES) to discontinue dual-antiplatelet therapy (DAPT), usually temporarily, and discontinuation did not significantly increase the risk of major cardiac events one-year post-implantation, according to a study published in the Oct. 9 issue of the Journal of the American College of Cardiology.

Apixaban’s benefit preserved across risk categories

The anticoagulant apixaban reduced the risk of stroke and bleeding in patients with nonvalvular atrial fibrillation (AF) and at least one risk factor for stroke without regard to the patients’ scores on the CHADS2, CHA2DS2VASc and HAS-BLED scales, according to a study published online Oct. 2 in Lancet.

Left main disease patients fare better with Xience than Taxus

Patients with unprotected left main disease who were treated with everolimus-eluting stents experienced significantly fewer major adverse cardiovascular events at the one-year mark than patients who received paclitaxel-eluting stents, according to a study published Oct. 2 in the Journal of the American College of Cardiology.

Blanket benefit of beta-blockers put in doubt

Beta-blockers’ status as a standard of care for coronary artery disease (CAD) patients with a previous MI, with no history of MI and those with CAD risk factors only may take a tumble, based on results of a study published Oct. 2 in the Journal of the American Medical Association.

Medicure to file supplemental NDA for high-dose bolus of Aggrastat

Medicure plans to file a supplemental new drug application (sNDA) for the high-dose bolus (HDB) dosing regimen of tirofiban HCl (Aggrastat). The company also announced that the FDA has granted its request for a waiver of the $979,400 application fee for the planned sNDA.

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