At the congress of the European Societey of Cardiology (ESC) 2010, Siemens will present new image processing software that helps cardiologists and cardiac surgeons perform transcatheter aortic valve implantations (TAVI): Syngo Aortic ValveGuide automatically reconstructs a 3D representation of the aortic root from CT-like cross-sectional images acquired with the angiography system. The software selects anatomical landmarks as the coronary ostia, for instance, and overlays the 3D image with two-dimensional images acquired during live fluoroscopy.

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Boston Scientific Corporation has announced the start of patient enrollment in the EVOLVE clinical trial, which is designed to assess the safety and performance of its fourth-generation SYNERGY™ Coronary Stent. The SYNERGY Stent uses a bioabsorbable PLGA polymer and everolimus drug formulation to create a thin, uniform coating confined to the outer surface of the stent. Once the drug has been delivered, the bioabsorbable coating resorbs into the body, leaving behind only a bare-metal stent.

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Scottsdale Healthcare is testing a new under-the-skin device that uses an electrical shock to interrupt possibly fatal heart rhythms, restoring a normal heartbeat for patients at high risk of sudden cardiac arrest. The first Arizona patient received the device at Scottsdale Healthcare Shea Medical Center. The subcutaneous implantable cardioverter defibrillator uses life-saving electrical impulses under the skin near the heart, instead of placing electrical wires through veins to access the heart used in conventional methods.

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Medtronic, Inc. has announced European launch of the Protecta™ portfolio of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy-defibrillators (CRT-Ds). The implantable defibrillators feature Medtronic-exclusive SmartShock™ Technology, comprised of six advanced shock-reduction algorithms that can significantly reduce inappropriate shocks. Findings from the Virtual ICD study statistical model predicted 98 percent of studied patients with SmartShock Technology would be free of inappropriate shocks one year after implant and 92 percent at five years post-implant.

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A new platinum-based stent, designed by Boston Scientific, has received its CE Mark and will now be available in the relevant countries. The PROMUS Element Everolimus-Eluting Coronary Stent System was granted approval by the Dutch notified body KEMA Quality BV. In addition to featuring a platinum chromium alloy designed specifically for coronary stenting, the system has an innovative stent structure and an impressive catheter delivery mechanism.

FlowCardia, Inc has launched the FlowMate Injector, which dramatically simplifies central lumen crossing of CTOs using the CROSSER CTO Recanalization Catheter. FlowMate provides unparalleled convenience by granting full control of the procedure to a physician via a single foot pedal, which initiates FlowMate’s precise saline delivery as well as the Generator which activates the CROSSER Catheter. Fixed injector settings are integrated into the FlowMate adding even greater convenience and ease of use.

Sorin Group has announced the Japanese approval and the market release of ISOLINETM1, its latest generation of defibrillation leads. Leads are insulated wires inserted through the vein as part of an implantable cardioverter defibrillator (ICD) or a pacemaker system. Connecting the device to the heart, the leads carry high voltage and electrical impulses from the implanted device to the heart when needed by the patient. ISOLINETM defibrillation leads have a multi-lumen structure with a silicone body and include an ETFE protective coating placed around the cables leading to the electrodes.

The U.S. Food and Drug Administration has given 510(k) clearance to Cardium Therapeutics’ operating unit InnerCool Therapies, Inc. for the commercialization of its RapidBlue(TM) System, a system to regulate body temperature. The closed loop catheter-based system of the device modulates body temperature by circulating saline within the catheter’s interior. Underwriters Laboratories found that the system met all the medical electrical safety standards including UL 471 Standard for commercial refrigerators, the first global certification for an endovascular thermal regulating device.

The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

The U.S. Food and Drug Administration has given the approval in the form of a Humanitarian Device Exemption (HDE) for Levitronix’s CentriMag Right Ventricular Assist System providing patients in critical condition with temporary aid for the right ventricle of their heart. The heart pump supports the pumping action of a heart not functioning properly. The indication facilitates the development of the device for treatment of the severe right-side heart failure, which although uncommon, can lead to death. The device was found to be safe for use.