Carotid stenting is a more complex and challenging procedure than coronaries or peripheral vessels. Carotid stenting experts have the following advice for hospitals and physicians that want to enter this market.

July 14, 2011 — The U.S. Food and Drug Administration (FDA) has conditionally approved the protocol for SYMPLICITY HTN-3, the U.S. clinical trial of renal denervation with the Symplicity catheter system for the treatment of resistant hypertension (high blood pressure in the presence of three or more medications). Patient enrollment in the landmark study is expected to start soon.


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.

July 13, 2011 – InfraReDx Inc. announced enrollment of the first patient in its Phase 2 clinical trial, CANARY (Coronary Assessment by Near-infrared [NIR] of Atherosclerotic Rupture-prone Yellow). CANARY is designed to test the hypothesis that NIR-guided use of an embolic protection device (EPD), or filter, during percutaneous coronary intervention (PCI) can reduce the rate of peri-procedural heart attacks in patients identified as having high-risk lipid core plaques (HR-LCPs). InfraReDx’s LipiScan IVUS System is the only multimodality coronary imaging device approved in both the United States and Europe. It is in routine clinical use to detect the LCPs known to complicate stenting and suspected to cause most heart attacks.

July 13, 2011 – Many children and teens suffering from tachycardia, or rapid heart rate, have relied on medication to regulate their heart rhythms and control symptoms such as fatigue, dizziness and fainting spells. However, doctors at the Akron Children's Hospital Arrhythmia Center have made great strides in curing tachycardia with minimally invasive procedures.

July 13, 2011 – The TandemHeart circulatory support system has been granted expanded reimbursement coverage by NHIC Corp., the medicare administrative contractor (MAC) serving over 1.3 million beneficiaries and over 53,000 healthcare providers in the Northeast region of the United States.

July 13, 2011 – Based on its recent analysis of the medical imaging market, Siemens Healthcare was given the 2011 North American Frost & Sullivan Award for New Product Innovation. Siemens' Biograph mMR is the first scanner capable of simultaneously acquiring whole-body positron emission tomography (PET) and magnetic resonance imaging (MRI) data.

July 12, 2011 – To streamline diagnosis and enable greater overall exam efficiency, Toshiba America Medical Systems Inc. has announced U.S. Food and Drug Administration (FDA) approval of VirtualExplorer Version 3.1, a software upgrade package for Toshiba Magnetic Resonance (MR) VirtualExplorer workstations. The software provides enhanced post-processing functionality, and the new cardiac package includes MR flow analysis, which allows clinicians to measure flow and velocity when imaging the heart.

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