• Abbott Laboratories (Abbott Park, Illinois) reported the launch of the sixth-generation Emboshield NAV6 Embolic Protection System for use in carotid artery stenting procedures. Carotid artery stenting provides a minimally invasive treatment alternative to conventional open carotid artery surgery for patients who are at high risk for surgery. Embolic protection systems are used during the stenting procedure to prevent particles of dislodged plaque from flowing to the brain, potentially causing an ischemic stroke. In the Emboshield NAV6, Abbott's BareWire technology allows for wire movement independent of the Emboshield NAV6 filter, giving physicians an increased level of control during carotid stenting procedures.

• Merge Healthcare (Milwaukee) reported the release of MergeCOM-3 version 4.0, which uses the latest updates to the DICOM standard, as well as new interfacing capabilities using the HL7 standard. Version 4.0 contains support for the latest DICOM standard Supplements, including high definition video, mammography and color MRI. This new release exemplifies Merge's commitment to consistently maintain the latest DICOM standards in its MergeCOM-3 toolkits. The HL7 Toolkit includes the HL7 v2.5.1 library along with extensive mapping capabilities, sample applications and documentation.

• Non-Invasive Monitoring Systems (NIMS; Miami) said that the FDA has cleared NIMS to market the Exer-Rest, a Class I (exempt) medical device, with the expanded indication to reduce morning stiffness. Exer-Rest is marketed as an aid to temporarily increase local circulation, to provide temporary relief of minor aches and pains, as well as to support local muscle relaxation. Exer-Rest produces Whole Body Periodic Acceleration (WBPA) through repetitive movements of the body in a head to foot direction at approximately 140 times per minute as the individual lies horizontally and comfortably on the device during a 30 to 45 minute session.

• Rex Medical (Conshohocken, Pennsylvania) has received FDA clearance and CE-mark approval for the Option Retrievable Vena Cava Filter in the prevention of recurrent pulmonary embolism (PE). The Option Filter has received marketing clearance for both permanent and temporary implantation indications and may be retrieved (removed from the patient) if the physician determines the patient is no longer at substantial risk for PE. Option is a self-centering, low-profile, high-performance vena cava filter. This novel design incorporates proven nitinol construction in a 6 Fr delivery system for precise delivery, increased stability, efficient clot capture and resorption, and long term device retrieval (U.S. indication of 175 days post-implantation).

• Spinal Restoration (Austin, Texas) said it has submitted the six-month primary endpoint results from an ongoing 2-year IDE pilot study of the Biostat System for treatment of chronic low back pain due to symptomatic internal disc disruptions to the FDA. The Biostat System consists of Biostat Biologx fibrin sealant, a human derived, resorbable biologic tissue sealant, and a application system designed to safely deliver the biologic to the intervertebral disc. Application of Biostat Biologx fibrin sealant to the disc may alleviate discogenic pain by sealing the painful disruptions, reducing inflammation, and enhancing tissue repair.

• St. Jude Medical (St. Paul, Minnesota) reported the first implant of its Current Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system. The system features a single connection between the device and the defibrillation lead, and single set screw (used to tighten and secure the lead to the device). It is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization, but will not be labeled as such until the standard is finalized, which is expected later this year.

• Ventus Medical (Seattle) said clinical data further confirm Provent Sleep Apnea Therapy's clinical utility in treating mild, moderate and severe obstructive sleep apnea (OSA). Provent Therapy is a prescription device indicated for the treatment of OSA. The prescription treatment works across mild, moderate, and severe OSA. The treatment uses nasal expiratory positive airway pressure and has been clinically shown to reduce sleep apnea. It incorporates a novel MicroValve design that is placed over the nostrils and secured with hypoallergenic adhesive. During inhalation, the valve opens allowing nearly unobstructed airflow, and during exhalation, the valve closes, limiting airflow through two small openings, which increases expiratory pressure.