September 10, 2010 – Cath Labs are being encouraged this week by the U.S. Food and Drug Administration (FDA) to inspect their inventories for AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty (PTCA) Scoring Balloon Catheters. Devices manufactured between Jan. 30 and Dec. 4, 2009 are part of a class 1 product recall due to safety concerns.

September 10, 2010 – The U.S. Food and Drug Administration (FDA) is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF). The condition may occur if the drug is administered to certain patients with kidney disease.

September 10, 2010 – With new tax on medical devices beginning in 2013, a guidewire original equipment manufacturer (OEM) believes this may dampen future funding for research and development. However, Lake Region Medical said it may offer greater opportunities to partner with the larger vendors it supplies as they try to make advancements in non-core products, such as guidewires.

September 10, 2010 – The first patient was successfully supported for six days by the Impella Right Peripheral (RP) ventricular assist device (VAD) at the Providence Heart and Lung Institute at St. Paul’s Hospital in Vancouver, British Columbia. This is the first use of the Impella RP.

September 8, 2010 – Total complications for new implantable cardioverter defibrillator (ICD) implants (including death in the laboratory) have decreased from 3.77 percent in 2006 to 2.87 percent in 2009, according to new data from the National ICD Registry.

September 8. 2010 – Intravascular ultrasound (IVUS)-guided bifurcation stenting significantly reduced the four-year mortality in patients as compared to conventional angiographically guided stenting, according to a recent study.

September 8, 2010 – The increased effectiveness of ticagrelor (Brilinta) in overcoming high platelet reactivity as compared to the gold-standard of clopidogrel (Plavix) was shown in data presented last week at the European Society of Cardiology (ESC) Congress in Stockholm.

A major issue in treating chronic total occlusions (CTOs) is the lack of angiographic visualization. The flow of blood and contrast is completely blocked, eliminating the ability to navigate the vessel or see where wires are being poked. Not being able to see what you are treating is a big reason why operators do not attempt these lesions.



Following cath lab procedures, the final step is to attain hemostasis at the arteriotomy access site. Manual compression has been the gold standard for decades, but vascular closure devices (VCDs) can speed wound closure, and hemostatic pads can help decrease clotting times. VCDs and the new dressings also accelerate patient ambulation.



Coronary chronic total occlusions (CTOs) are found in about one-third of patients who undergo angiography.(1) Most of these patients are referred to coronary artery bypass graft (CABG) surgery or medical therapy because these lesions are very challenging to treat using conventional percutaneous coronary interventional (PCI) techniques.


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