• ev3 (Plymouth, Minnesota) said it has received approval to include the SpideRX Embolic Protection Device in the second arm of its carotid clinical trial, CREATE (carotid revascularization with ev3 arterial technology evolution). ev3 has completed enrollment in the first phase of this trial using the SPIDER Embolic Device and the Protege GPS Self-Expanding Stent. The 30-day results of the first phase will be presented in a late-breaking trials session at the Society of Interventional Radiologists meeting in New Orleans on April 3. The second phase of the trial will evaluate the SpideRX device when used with the commercially available RX Acculink Carotid Stent System from Guidant (Indianapolis). The SpideRX Device, like its predecessor product, has a unique nitinol filter. The new device is designed to provide more efficient delivery, capture and recovery, while still allowing interventionalists to use their interventional wire of choice. Improvements over the current device include a complete rapid exchange system, 6 Fr guide catheter compatibility and a dual-end delivery/ recovery catheter with a pre-loaded capture wire.

• Gambro BCT (Lakewood, Colorado), a wholly owned subsidiary of Gambro AB (Stockholm, Sweden), reported that the FDA has cleared apheresis platelets collected with its Trima and COBE Spectra Collection Systems for routine storage and patient transfusion up to seven days, when tested with the bioMerieux (Lyons, France) BacT/ALERT Microbial Detection System Release Test. Currently all bacterial detection systems are cleared as QC Test systems that only permit five-day storage. When used to test Gambro BCT platelets per the company specified methods, the BacT/ALERT Microbial Detection System testing is considered a release test for Gambro BCT platelets. This requires the use of both aerobic and anaerobic cultures. To implement seven-day platelets, blood centers will need to work with the FDA to obtain proper approvals to use the BacT/ALERT as a release test. Gambro BCT is sponsoring an extensive post-market surveillance study to further evaluate the performance characteristics of this testing system. Combined with the BacT/ALERT Release Test, Gambro BCT platelets are the only platelets that can be transfused to patients up to seven days after collection.

• Spacelabs Medical (Issaquah, Washington) has introduced TruLink SpO₂ Sensors, a new line of reusable and single-patient use pulse oximetry sensors, in a variety of sizes ranging from neonate to adult. TruLink SpO2 Sensors can be used with all Spacelabs Ultraview Command Modules and UltraviewSL Command Modules. The new line is also compatible with a wide variety of other manufacturers' patient monitors as well as Nellcor (Pleasanton, California) pulse oximeters. The "C" shape design of the single-patient use sensors affords an improved fit for patient comfort and can be reapplied to the same patient. Reusable sensors include both a finger clip and "Y" probe that are convenient to apply and provide a secure fit to a range of patients.

• Stratagene (Garden Grove, California), a manufacturer of specialized research and diagnostic products, reported that its wholly owned subsidiary, Hycor Biomedical, has received FDA clearance to market its Anti-Tissue Transglutaminase (tTG) IgG autoimmune test. tTG is used in the diagnosis of celiac disease. The new test complements the tTG IgA test cleared by the FDA in 2004. The company said all of its tests can be performed using a manual procedure or the procedures can be fully automated by using its HY-TEC 288 Plus Automated Immunoassay System.

• Tensys Medical (San Diego), a leader in real-time blood pressure management, reported the introduction of the TL-150, a continuous, non-invasive blood pressure monitoring system with accuracy clinically proven equivalent to an arterial line. The company said the TL-150 introduces significant technological advancements over the original T-Line system, including improvements such as reduced set-up time and improved motion tolerance. The non-invasive, beat-to-beat capability of the new TL-150 enables continuous monitoring of even the most difficult surgical patients and provides the confidence of real-time feedback on the impact of interventions for optimal blood pressure management, Tensys said.

• Thoratec (Pleasanton, California) reported that the first patients have been enrolled in the destination therapy and bridge-to-transplantation (BTT) arms of the Phase II pivotal trial for its HeartMate II LVAS (left ventricular assist system) device. This is in addition to the 25 BTT patients that were enrolled in the Phase I trial. Thoratec said that several of the participating centers have received institutional review board approval to participate in the study. The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure.

• Toshiba Medical Systems (Tokyo) reported the beginning of patient evaluations in what it said is the industry's first multi-center clinical study on coronary computed tomography angiography (CTA) imaging using 64-slice CT technology. Initial results of the study will be released in 2006. In November 2004, Toshiba launched CorE 64 (Coronary Evaluation on 64), an international collaboration with its partners to investigate the use of multislice CT as the primary diagnostic tool for detecting cardiovascular diseases and disorders, as compared to cardiac catheterization. The patient evaluations will involve non-invasive diagnostic imaging of cardiac patients using Toshiba's CT technologies, such as the Aquilion CFX 64-slice CT, 64-row Quantum Detector and SURECardio and SUREPlaque applications for a period of several months, as well as regular meetings with the study group to measure and discuss the clinical effectiveness of cardiac CT imaging against cardiac catheterizations.