• Concentric Medical (Mountain View, California) and the SITS Network (Stockholm, Sweden) reported their partnership on the THRUST (Thrombectomy in Unsuccessful Stroke Thrombolysis) study, to be sponsored by Concentric Medical and managed by the SITS Network. The study is anticipated to begin enrolling patients later this year, and will investigate the Merci Retrieval procedure in ischemic stroke patients who fail standard thrombolytic therapy. THRUST will compare the clinical outcome of patients treated with mechanical thrombectomy using the Merci Retrieval System vs. patients with no further intervention. Concentric Medical is focused on developing new stroke treatments, while the objective of the SITS Network is the broad implementation and amplification of evidence-based stroke treatments.

• Cyberonics (Houston) said that the first nine patients have been enrolled in a year-long Vagus Nerve Stimulation (VNS) Therapy dosing study that will examine treatment outcomes for patients with treatment-resistant depression (TRD) who are randomized to three different doses of VNS Therapy. About 460 patients at 30 study sites will be enrolled in the multicenter, double-blind study. The company said data collected from the study will provide guidance to psychiatrists regarding the relationship between dosage and efficacy for treating patients with VNS Therapy. VNS Therapy is the first FDA-approved implantable device-based treatment for depression and the first treatment developed, studied, approved and labeled specifically for patients with TRD.

• Genzyme (Cambridge, Massachusetts) reported the availability of two new molecular tests for acute myelogenous leukemia with the launch of FLT3 Mutation Analysis and WT1 RQ-PCR. FLT3 mutations are considered a prognostic indicator of poor survival and response to standard chemotherapies. Designed to detect minimal residual disease, the WT1 RQ PCR test allows physicians to monitor AML patients for early relapse during and following therapy. Together, these tests may enable oncologists to better manage their patients, the company said.

• LI-COR Biosciences (Lincoln, Nebraska), a manufacturer of integrated infrared instrument systems and reagents, reported the introduction of IRDye Western kits for the Odyssey Infrared Imaging System. The kits feature IRDye 800 CW and IRDye 680 labeled secondary antibodies, Odyssey Blocking Buffer and PVDF membranes. The company also is introducing six new IRDye 700 oligos for gel shift assays (EMSAs) and a new EMSA Buffer kit optimized for use on the Odyssey system. The company said the infrared-dye based oligos offer distinct advantages over radioisotopes including long-term dye stability, rapid detection, and the flexibility to extend gel run times.

Nasal drug delivery specialist OptiNose (Oslo, Norway) reported the presentation of new data on its breath-actuated powder and liquid drug delivery devices at Drug Delivery 2006 in San Diego. Deposition data for the breath-actuated powder delivery device in nine volunteers show a statistically significant increase (400%) in drug deposition in the upper posterior segment compared to traditional nasal spray pumps. The ability to deliver drug to the upper posterior part of the nose also enables the OptiNose devices to be used for targeted nose-to-brain delivery of CNS compounds for treatment of neurological diseases, the company said.

• Raymedica (Minneapolis) said that results from a 10-year clinical evaluation of patients implanted with the first generation PDN Prosthetic Disc Nucleus technology indicate the patients improved or maintained their range of motion and experienced early and sustained pain reduction. The findings of the retrospective analysis were presented at the Spine Arthroplasty Society meeting in Montreal. Raymedica's PDN technology is a pre-formed hydrogel encased in a polyethylene jacket that has flexibility to facilitate delivery through a standard posterior approach and allows conformability to adapt to the human intervertebral disc space.

• Smiths Medical (St. Paul, Minnesota), part of the global engineering business Smiths Group, reported that it has launched the LockIt Plus Catheter Securement Device, a new catheter fixation product designed to secure regional anesthesia catheters at skin level and prevent migration. The LockIt Plus consists of a large adhesive pad with an easy-to-peel backing that makes application easy and ensures adherence to the skin, and a transparent locking mechanism that allows clinicians to view the catheter exit site. After an epidural catheter is inserted into a patient, a LockIt Plus device is threaded over the catheter and adhered to the patient over the insertion site. Once adhered, the clear latch is closed to fixate the catheter to the skin. The device is available for catheters used with 16 and 17 gauge epidural needles. The same device for use with 18 guage needles will be released in the near future.

• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of its newest devices for treating patients with heart arrhythmias and heart failure. The Epic II ICD (implantable cardioverter defibrillator) and the Epic II HF CRT-D (cardiac resynchronization therapy defibrillator) devices feature enhanced telemetry speed for faster device communications and a “patient notifier” that gently vibrates to alert patients of critical changes in device function. The Epic II devices also include SenseAbility technology designed to allow optimizing of sensing parameters that may protect against inappropriate ICD shocks; AutoIntrinsic Conduction Search, intended to promote more natural heart function and minimize ventricular pacing; and DeFT Response technology to help physicians manage patients who require higher levels of defibrillation. The Epic II ICD and Epic II HF CRT-D will be released for sale this month in the U.S. market.

• Stereotaxis (St. Louis) reported the completion of a proof-of-concept demonstration of a magnetically enabled endocardial injection catheter developed in collaboration with the Biologics Delivery Systems Group of Cordis (Miami Lakes, Florida). The procedure, performed by Emerson Perin, MD, of the Texas Heart Institute, St. Luke's Hospital (Houston), involved the remote magnetic steering of the Stereotaxis Niobe Magnetic Navigation System, the electromechanical mapping features of the Noga XP Cardiac Navigation System and a uniquely designed, magnetically enabled injection catheter. Performing the entire procedure remotely from the control room, Perin mapped the left ventricle and identified and easily navigated the magnetic injection catheter to 15 targeted injection sites in the left ventricle. He was able to obtain excellent injection delivery, including delivery to the most challenging ventricular locations.

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