A drug-eluting, self-expanding stent that does not use a drug-carrier polymer is before the U.S. Food and Drug Administration (FDA) final pre-market approval (PMA) review and a decision is expected later this year. Its chances of approval appear very bright, considering its positive clinical trial data to date.

Catheter-based intra-cardiac echocardiography (ICE) is an imaging modality similar to intra-vascular ultrasound (IVUS). It allows imaging inside the heart to visualize cardiac structures and blood flow using Doppler imaging. The standard-of-care for this type of imaging is usually transesophageal echo (TEE), but ICE proponents say the intra-cardiac modality has several advantages.

These are some of the top cardiology technology news items from the spring and early summer 2011. As part of its efforts to expand integration of intravascular ultrasound (IVUS) image guidance with cath lab treatment devices, Volcano Corp. recently announced a supply agreement with ev3, a Covidien company. Volcano will supply its IVUS technology for use in ev3’s TurboHawk plaque excision (atherectomy) systems.

In a move that will likely have a significant impact on how many patients are treated for carotid artery disease, the U.S. Food and Drug Administration (FDA) in May cleared the use of a stent to treat standard-risk surgical patients. Prior to this approval, carotid stenting was only indicated for use in high-risk surgical patients who were often denied the standard-of-care of carotid endarterectomy surgery. The decision to expand the indication for the Abbott RX Acculink carotid stent system is expected to have a major impact, offering patients the option of minimally invasive stenting rather than open surgery, which often leaves scars on the patient’s neck.