• CryoLife (Kennesaw, Georgia) reported the first implantation of its combination aortic-mitral allograft heart valve in a patient at the Cleveland Clinic. The method used to process the combination aortic-mitral human heart valve was developed by CryoLife in collaboration with the Cleveland Clinic (Cleveland). The valve was developed as a replacement option for patients with infective endocarditis involving both the aortic and mitral valves. Infective endocarditis is a condition in which the structures of the heart, particularly the heart valves, are infected. "Infections involving both the mitral and aortic valves put patients at very high risk for serious complications that can result in death," said Jose Navia, MD, a cardiac surgeon with the Heart and Vascular Institute at the Cleveland Clinic. "With the new human tissue combination aortic-mitral heart valve, we are hoping to provide an infection-resistant treatment option to offer patients." CryoLife makes implantable living human tissues for use in cardiac and vascular surgeries.
• Nuance Communications (Burlington, Massachusetts) reported the introduction of version 5.0 of its Dictaphone PowerScribe for radiology speech-enabled reporting solution. The new product enhancements and integration capabilities are geared to support and improve the radiology workflow process, with a concentrated focus on highly accurate, comprehensive and readily available clinical documentation. Product highlights of the PowerScribe include enhanced voice recognition reduces word error rate by 35%, workflow engine enhancements, system technology upgrades and new graphical user interface. Nuance Communications makes speech solutions.
• PhotoMedex (Montgomeryville, Pennsylvania) said it has received FDA clearance to market the Xtrac velocity excimer laser system to treat psoriasis, vitiligo, atopic dermatitis and leukoderma. The Xtrac delivers UV power, while retaining all the efficacy of its predecessor, the Xtrac Ultra. PhotoMedex makes excimer laser and fiber optic systems as well as techniques directed toward dermatological applications.
• St. Jude Medical (St. Paul, Minnesota) reported FDA clearance and CE-mark approval of the Strada carotid guiding sheath, a flexible tube through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries. The Strada is designed specifically to provide easier and faster access to challenging carotid anatomy. The Strada is engineered with five distinct transition zones to provide flexibility on the far, or distal, end of the sheath, and support on the near, or proximal, end of the sheath. Its construction provides excellent kink resistance for added confidence in navigating challenging anatomy. The Strada is available in 80 cm and 90 cm working lengths.
St. Jude Medical also reported the release of its EnSite system version 8.0 software. The software will help physicians more intuitively visualize the anatomy of the heart to diagnose and treat abnormal heart rhythms. The EnSite is used in minimally invasive electrophysiology procedures. Catheters with electrodes are inserted into the cardiac chamber and then are located and visualized by the EnSite, which records electrical information and creates a rendering of the chamber anatomy. The resulting images help physicians create detailed heart models to facilitate the diagnosis and delivery of therapy for abnormal atrial heart rhythms, including atrial fibrillation. The EnSite allows catheter navigation to occur without fluoroscopy and reduces the risk associated with too much exposure to X-rays. St. Jude Medical specializes in cardiac, neurological and chronic pain products.