• Lumen Biomedical (Plymouth, Minnesota) reported FDA clearance from the FDA to market two additional sizes of their Xtract aspiration catheter in the U.S. The Xtract, which is indicated for use in the removal of soft, fresh thrombi (clots) and emboli from arteries in the body, is now available in two larger sizes (5 Fr and 5.8 Fr). The smaller catheter size (4.2Fr) was granted FDA clearance June 2006. Clots can restrict or interrupt blood flow within an artery, creating severe complications in patients. Thromboses events can be caused by physiological conditions or from interventional procedures themselves, one such complication being stent thrombosis. The Xtract is designed to remove fresh, soft emboli or thrombi from the arterial system. The catheter features a braided shaft for responsive delivery and kink resistance, a large aspiration lumen, and a soft curved tip to negotiate obstructions and provide directional suction. Lumen Biomedical makes products that can be used in any anatomical area where embolic protection or emboli removal is required.

• MedPlexus (Sunnyvale, California) reported the availability of its Software-as-a-Service (SaaS) suite of solutions, which include practice management software, electronic health records (EHRs) and a browser-based patient self-service portal. The solution also includes SaaS-enabled services for billing, front-office call management, and practice audit and accounting services. Under the SaaS model, MedPlexus hosts the applications and manages the maintenance, software upgrades and disaster recovery, thus, it said, minimizing the risks and costs incurred by the physician practice and/or healthcare organization while allowing physicians to return to the realm of providing care as opposed to managing technology solutions. MedPlexus makes internet-based administrative, financial and clinical software and services for physician practices.

• Neuromonics (Bethlehem, Pennsylvania) reported the initiation of the first post-market U.S. study to evaluate long-term outcomes for its neuromonics tinnitus treatment. This is an FDA-cleared therapy designed to interact, interrupt and desensitize tinnitus disturbance for long-term benefit. Neuromonics’ device is customized to the patient’s unique hearing and tinnitus profile. It delivers a customized neural stimulus that promotes neural plastic changes, allowing the brain to filter and process the tinnitus. The delivery system, to carry the neural stimulus, consists of spectrally modified customized music which engages the brain’s emotional response center, the limbic system. Neuromonics makes medical devices designed for long-term significant relief of tinnitus.

No Comments