Abiomed (Danvers, Massachusetts) reported FDA approval of its premarket approval supplement for the company's new integrated cannula system. The cannula has the potential for use off-pump with minimally invasive procedures and is designed to integrate with Abiomed's AB5000 and BVS 5000 Circulatory Support Systems. The new cannula system is easier to implant and explant and is expected to standardize surgical procedures for acute heart failure patients. Abiomed's cannula system provides an enhanced benefit, since patients will not require a second sternotomy during off-pump explantations. The new system consists of a 42 Fr cannula, surgical sewing cuff and an inline connector for precise implantation and reduced blood loss for patients in acute heart failure. The apical cannulation system is designed to simplify and minimize blood loss during implantation and explantation. A key feature is a sliding seal that helps to control bleeding during procedures.

• ICU Medical (San Clemente, California), a developer of needle-free intravenous connection devices, unveiled the Tego Connector, the first catheter protection device designed specifically for use in hemodialysis treatments. The Tego protects the catheter from contamination during hemodialysis sessions, preventing bloodstream infections for the patient and helping prevent revenue losses for dialysis clinics. The Tego Connector creates a mechanically and microbiologically closed system when attached to the hub of the catheter. This closed system eliminates any manipulation of the catheter hub while attaching or removing blood lines, which helps prevent contamination and, consequently, bloodstream infections for the patient.

• Perio Protect (St. Louis) reported that its non-surgical treatment device for treating gum disease has been cleared for general use by the FDA. The Perio Protect Method uses customized trays that fit comfortably over the teeth and are worn at home for minutes each day to deliver antimicrobial medication directly to the source of infection. The design of Perio Protect Trays permits doctor-chosen medications to surround and remain in the periodontal pocket long enough to kill bacteria and modify the protein biofilm on the teeth, making it easy to remove calculus and tarter. Worn as a supplement to regular brushing and flossing, the treatments are modified as healing occurs. Once the disease is under control, patients use the Perio Protect system as their long-term homecare regimen to prevent a reoccurrence.

• RITA Medical Systems (Fremont, California), focused on cancer therapies, reported that the company has begun sales of the LC Bead in the U.S. The new product is a minimally invasive embolization treatment for hypervascular tumors that blocks the blood flow feeding a tumor, causing it to shrink in size over time. RITA has an exclusive three-year supply and distribution agreement with the manufacturer of the LC Bead, Biocompatibles International (Barnham, UK), to market the product in the U.S. and Canada.

• Uroplasty (Minnetonka, Minnesota) reported that it has initiated a postmarket, multicenter clinical study with its Urgent PC Neuromodulation System at urology and urogynecology centers across the U.S. The study is a randomized, controlled, clinical study comparing percutaneous tibial nerve stimulation using the Urgent PC against a major drug therapy. The postmarket clinical study will evaluate reductions in overactive bladder symptoms of urge urinary incontinence, and urgency and frequency of urinary voids, as well as void volumes, quality of life measures, physician assessments and cost-effectiveness.

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