April 17, 2012 - Approximately 6 million Americans have brain aneurysms, a condition that occurs when a weak or thin spot develops on a blood vessel in the brain causing it to balloon. Often, these do not cause symptoms and go undetected, but every year an estimated 30,000 Americans experience a ruptured aneurysm that bleeds into the brain causing a life threatening injury. Immediate medical treatment is necessary to prevent stroke, nerve damage or death, and includes surgery or coiling. Coiling is an approach that blocks blood flow to the aneurysm by filling it with platinum coils. While less invasive than surgery, the likelihood of future aneurysm recurrence and subsequent treatment is higher with coiling. In an effort to lower the risk for repeat aneurysm treatment after coiling, Northwestern Medicine researchers are examining a new type of gel-coated coil to determine if it is more effective than the standard bare coils in preventing aneurysm recurrence.

April 12, 2012 – Abbott announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the next-generation Xience Prime Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE PRIME, which uses the same drug and biocompatible polymer as the XIENCE V Everolimus Eluting Coronary Stent System, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement. With this approval in Japan, XIENCE PRIME is available in all of the major markets worldwide, including the United States, Europe, China, India and other countries in the Asia-Pacific and Latin America regions.

April 17, 2012 - On April 9, 2012, the FDA's Center for Devices and Radiological Health (CDRH) launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0." This program offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

April 17, 2012 – SynCardia Systems Inc., manufacturer of the world’s first and only FDA-, Health Canada- and CE-approved Total Artificial Heart, announced that the U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.

April 16, 2012 — Medic Vision Imaging Solutions Ltd. announced that within six months of clinical use in the United States, its SafeCT image enhancement system has delivered diagnostic image quality to more than 20,000 CT (computed tomography) studies acquired with low-dose protocols.

April 16, 2012 - 480 Biomedical announced that it has initiated the first human trial of its groundbreaking Stanza self-expanding bioresorbable scaffold for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). The Stanza scaffold restores blood flow to the leg by propping open the diseased artery during the critical healing period, similar to conventional metal stents, but then is resorbed by the body. Observations from the first patients in the STANCE trial were reported on April 14 at the 34th Charing
Cross International Symposium in London.

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