• Diomed Holdings (Andover, Massachusetts), maker of the EndoVenous Laser Treatment (EVLT) for varicose veins, reported the launch of its next-generation EVLT procedure kit. The kit features the Spotlight sheath and introducer with a specially treated tip to increase echogenicity, enhancing sheath visibility under ultrasound. The kit also offers improved sheath markings for more consistent delivery of laser energy, a new packaging configuration for ease of handling, an improved optical fiber locking mechanism, and a more versatile guidewire. The new EVLT kit has been in limited release since early January, with full commercial availability scheduled later this quarter. Kits with the Spotlight sheath will initially be available in a 45 cm length, with a 70 cm version available during the second quarter.

• OptiMedica (Santa Clara, California) said it demonstrated its new photocoagulator at the Macula 2006 Symposium in New York and the Hawaiian Eye/Retina 2006 annual meeting in Maui, Hawaii. In 2005, the company received FDA clearance for its PASCAL (pattern scan laser) laser for use in standard photocoagulation procedures, including pan-retinal photocoagulation for proliferative diabetic retinopathy and macular grid for diabetic macular edema. The 532 nm laser photocoagulator is a proprietary semi-automated pattern generation method. The pattern array options include single spot, square arrays, octants, quadrants, macular grid and arcs, with as many as 25 spots delivered in 0.5 seconds. The system incorporates advancements in ergonomics as well as controls and displays, including the LCD touch-screen and the dual slit lamp mounted electronic micromanipulators and rotary power controls.

• Philips Medical Systems (Andover, Massachusetts) reported its new line of obstetrical care fetal and maternal monitors, Avalon FM20 antepartum and Avalon FM30 intrapartum. Built on Philips' IntelliVue patient monitoring platform, the Avalon fetal monitors feature enhanced functionality and documentation capabilities in a compact, ergonomic, and easy-to-use product. Both monitors can be used to monitor multiple births, with advanced features that include high-quality ultrasound tracing and cross channel verification. The Avalon FM20 and FM30 monitors integrate monitoring of maternal blood pressure and pulse rate with measurement of multiple fetal heart rates and uterine activity. The Avalon FM30 covers patients from the onset of contractions through the final stages of delivery with its full set of external and internal fetal parameters and maternal monitoring capabilities. Data from the monitors can be automatically transmitted to the Philips OB TraceVue obstetrical information system for comprehensive information management across the obstetrical care continuum. Philips also reported the availability of its new fetal monitoring starter kits – packages of companion supplies for the Avalon FM20 and Avalon FM30.

• Rafael Medical Technologies (Boston) reported that it has received conditional investigational device exemption approval from the FDA to begin the first phase of its U.S. clinical investigation of its SafeFlo Retrievable Vena Cava Filter for the prevention of pulmonary embolism. The trial is designed to evaluate the safety and efficacy of the SafeFlo filter in both permanent and temporary indications. A second phase of the trial will commence after completion of the first 10 patients in the initial phase of the U.S. study. The SafeFlo filter, which is CE marked and available in select European markets, is based on shape-memory nitinol wires and a design that provides an alternative anchoring mechanism to the standard strut-based designs of filters. SafeFlo's low-profile design is intended to be vessel-friendly and to afford simple and safe filter implantation with the ability to fully deploy, retrieve and reposition prior to detachment.

• Unilens Vision (Largo, Florida), a developer of specialty contact lenses, reported the launch of the first aspheric, single-vision, daily wear, two-week disposable soft contact lens ever available under the C-VUE brand. Wavefront technology, which measures the entire wavefront of light refracted by the eye, has been applied to the development of the C-VUE Aspheric single vision lens. The end result is a single-vision product with every available power delivering the maximum aberration control possible in a molded disposable lens.

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