At the Leipzig Interventional Course (LINC) in Leipzig, Germany, physicians from the U.S. and Europe presented data on their clinical experience with the IDEV Technologies (Webster, Texas) Supera stent. The primary clinical outcome of two of these 4 new studies was primary patency demonstrating independent, consistent and impressive one-year primary patency results of 86% and 88% with the third study producing a 92% Freedom from Target Lesion Revascularization (TLR). The Supera stent is engineered with interwoven wire technology that mimics vascular anatomy. It is indicated for the palliative treatment of biliary strictures produced by malignant neoplasms and in multiple other countries for the treatment of biliary strictures produced by malignant neoplasms and for peripheral vascular use following failed percutaneous transluminal angioplasty.

• myoscience (Redwood City, California) said its next generation device has received FDA clearance for treatment of peripheral nerve tissue using Focused Cold Therapy for the blocking of pain. Focused Cold Therapy, myoscience's platform technology, relies upon the well-established science of cryoneuromodulation to precisely deliver cold to peripheral nerve tissue. Nerves treated with this technology undergo a predictable period of dormancy, followed by complete restoration of function. The effects of Focused Cold Therapy are immediate, with patients experiencing instant pain relief and the ability to return to normal activities with minimal downtime.

• Sirtex (Woburn, Massachusetts) reported the results of a large multi-center clinical study re-affirming the safety and efficacy of Selective Internal Radiation Therapy (SIRT) with SIR-Spheres® microspheres in patients with metastatic colorectal cancer were presented at the American Society of Clinical Oncology's 2013 Gastrointestinal Cancers Symposium. SIR-Spheres microspheres are FDA PMA approved for microsphere radiation therapy for the treatment of colorectal liver metastases. The microspheres are administered via the hepatic artery, either alone, or in conjunction with systemic chemotherapy. SIRT, also known as radioembolization, is a technology for inoperable liver cancer that delivers doses of radiation directly to the site of tumors. In a minimally invasive treatment, millions of radioactive SIR-Spheres microspheres are infused via a catheter into the liver where they selectively target liver tumors with a dose of internal radiation up to 40 times higher than conventional radiotherapy, while sparing healthy tissue. Clinical studies have confirmed that patients with metastatic colorectal cancer treated with SIR-Spheres microspheres have response rates higher than with other forms of treatment, resulting in increased life expectancy, greater periods without tumor activity and improved quality of life. SIRT has been found to shrink liver tumors more than chemotherapy alone.

• Varian Medical Systems (Palo Alto, California) has received FDA clearance for the company's Edge radiosurgery suite, a new dedicated system for performing advanced radiosurgery using innovative real-time tumor tracking and motion management technologies. Recent FDA 510(k) clearances cover the following technologies that are integrated into the Edge radiosurgery suite. These new technologies are also being made available as upgrades to other compatible Varian systems: The PerfectPitch couch: An integrated six degrees of freedom (6DoF) treatment couch that provides the accuracy, precision, and flexibility needed to position patients optimally, adjust their position to correct for any misalignments, and support them comfortably during treatment. The Advanced Motion & Image-Guided Radiotherapy (IGRT) package: An advanced motion management package that offers clinicians many options for using real-time imaging during radiotherapy treatments. Intracranial radiosurgery package: An integrated set of technologies for planning and delivering stereotactic radiosurgery treatments for tumors or functional abnormalities in the brain. Calypso system: Several enhancements have been incorporated into the Calypso system for real time tracking.

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