• Biotronik (Lake Oswego, Oregon) said that the recruitment phase of the TRUST study (Lumos-T Safely Reduces Routine Office Device Follow Up) has been completed early. TRUST is a randomized, multicenter trial of patients with implantable cardioverter defibrillators (ICD) using Biotronik Lumos and Lumax devices. The TRUST study will evaluate the effectiveness of using Home Monitoring technology to follow-up patients compared to periodic in-office follow-up. Home Monitoring is an innovation in cardiac device technology that Biotronik says it has pioneered. It allows patients to be monitored continuously and wirelessly by their physician from anywhere in the world and from any computer with an Internet connection. Unlike other systems which require cardiac device patients to activate remote monitoring (sometimes using complicated technology), Home Monitoring is automatic, mobile and requires no patient intervention. Biotronik makes remote device patient management systems.

• Cook Medical (Bloomington, Indiana) has been granted FDA clearance for the Celect vena cava filter. The Celect is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava and now can be optionally retrieved when clinically indicated. The filter is an implanted metal device used to capture hazardous blood clots caused by trauma, surgery or other medical conditions before they can reach the lungs, causing a pulmonary embolism. Using a conical shape, the Celect has a strut design that improves centering in the vessel and reduces in-growth except at the desired attachment points. Cook Medical specializes in the implantable vena cava filter market.

• EKOS (Bothell, Washington) a specialist in the field of microsonic accelerated thrombolysis (MAT), has introduced a new endovascular device that is 29 cm (roughly 30%) longer. MAT uses microsonic energy in combination with thrombolytic drugs to safely speed up the process of dissolving blood clots. The 135 cm offers more flexibility when selecting an access approach to a clot, particularly with taller patients. "Physicians had requested development of a longer device and this opens the door to treating more people,” said Robert Hubert, EKOS president/CEO. "Clots don't always form in easy-to-reach places and the 135cm significantly increases access to distal sites.”

• Haemonetics Software Solutions (Braintree, Massachusetts) reported FDA clearance for eLynx, a paperless data capture and temporary storage system for use in blood collection centers. eLynx streamlines and consolidates workflow activities. The automation ensures that standard operating procedures are followed, reducing the likelihood of errors while strengthening regulatory compliance efforts and accuracy. eLynx uses wireless technology on the donor floor to electronically capture all information related to blood collection procedures thereby reducing time for data collection and entry. eLynx tracks center supply usage, device calibration and preventative maintenance. eLynx can be integrated with any host software system to electronically complete the donation record. Haemonetics makes blood management solutions.

• Iomai (Gaithersburg, Maryland) reported positive interim results from the 500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with an injected vaccine for H5N1 influenza. The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in 73% of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone. With further testing, the patch has the potential to be used in conjunction with other injected pandemic influenza vaccines. Iomai makes vaccines and immune system stimulants.

• PLC Systems (Franklin, Massachusetts) said that it has received conditional approval from the FDA to begin enrollment in a U.S. pivotal trial to study the effectiveness of the company's RenalGuard Therapy and RenalGuard System in the prevention of contrast-induced nephropathy (CIN). RenalGuard is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects. RenalGuard is a fully-automated, real-time matched fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. PLC Systems is a medical technology company specializing in technologies for the cardiac and vascular markets.

• Smiths Medical (St. paul, Minnesota), part of the Smiths Group, reported FDA 510(k) clearance for its CADD-Solis Ambulatory Infusion System, calling it a next-generation ambulatory infusion platform. The CADD-Solis Ambulatory Infusion System includes: CADD-Solis Ambulatory Infusion Pump, CADD-Solis Medication Safety Software, and CADD Medication Cassette Reservoirs and Administration Sets. The pump features a large color graphic display screen, task-based software and cell-phone design. The safety software allows hospitals to create their own standardized pain management protocols, downloaded directly into each CADD-Solis pump so a clinician can easily select the specific pain management protocol for each patient's individual therapy needs.