• InfraReDx (Burlington, Massachusetts) said physicians at Beaumont Hospital (Royal Oak, Michigan) have successfully used its LipiScan coronary imaging system in a patient undergoing a cardiac catheterization. This is the first patient in whom it has been possible to assess the chemical composition of coronary artery plaques and use such information to assist in the management of coronary artery disease. The LipiScan is a catheter-based device that uses laser light to detect how much fat and other substances are contained in a plaque. The identification of the chemical composition of coronary plaques is expected to be of value to cardiologists in the selection of medical, stenting or surgical therapy for coronary lesions. The device is also expected to be of value to the pharmaceutical industry as a means to assess the effect of novel anti-atherosclerotic agents on lipid core plaque burden. InfraReDx specializes in near-infrared spectroscopic technology and its application to coronary imaging.
• Sirtex (Wilmington, Massachusetts) has begun a clinical trial evaluating the effect of treatment with SIR-Spheres microspheres on the survival of patients with unresectable hepatocelluar carcinoma (HCC). SIR-Spheres microspheres are currently FDA-approved for the treatment of unresectable metastatic liver tumors from primary colorectal cancer. Selective Internal Radiation Therapy (SIRT) using SIR-Spheres microspheres has been reported in a number of non-randomized trials to be effective and well tolerated in patients with unresectable HCC. Sirtex makes cancer therapies.
• Smith & Nephew's Endoscopy Division (Andover, Massachusetts) reported the launch of the Arthrogarde hip access cannula, designed to prevent inadvertent damage to soft tissue that can occur during arthroscopic hip repair surgery. During arthroscopy, surgeons frequently use a cannula to create a sterile pathway to the joint. They insert specialized devices through the cannula to diagnose and, if needed, repair damaged tissue in the joint. One challenge for surgeons has long been accessing the difficult-to-reach hip joint cavity without damaging the delicate cartilage surfaces within the joint. The rounded ends of the Arthrogarde provide a smooth surface to protect soft tissue as it penetrates the hip and enters the joint socket. The cannula wall has been thickened to provide additional strength and prevent bending or wear and tear over time. The endoscopy division of S&N specializes in orthopaedic reconstruction, orthopaedic trauma and clinical therapies.
• Spectranetics (Colorado Springs, Colorado) reported the availability of the LLD EZ lead locking device (LLD) for the removal of non-functional or infected pacing and defibrillation leads. The LLD EZ helps physicians to secure the entire lead creating traction to enable the removal process. LLD EZ uses a braided mesh that expands to secure leads along their hollow inner lumen permitting physicians to apply steady traction on the lead. The locking mechanism can be reversed, or unlocked, if the physician needs to remove the device from the lead or reposition it. LLD EZ also features an enhanced tip design and sleek profile to facilitate tracking and passage of the device through tight curves and beyond lumen damage. The specialized tip is radiopaque, enabling verification of tip location under fluoroscopy. Spectranetics makes excimer lasers for use in minimally invasive cardiovascular procedures.
• St. Jude Medical (St. Paul, Minnesota) reported FDA approval of the next-generation Merlin.net patient care network (PCN), an Internet-based central repository for patient device data gathered at the time of implant procedures, at in-clinic follow-up visits or from patient-initiated remote follow-up appointments. Merlin.net includes an automated interactive voice response feature, DirectCall message, which clinics can use to make routine telephone calls to patients. The DirectCall message automated system can call patients to remind them of upcoming remote follow-up appointments, or to notify them if they miss a remote follow-up appointment. DirectCall also can be used to ask patients to call the clinic, or to inform patients that their remote transmissions have been reviewed by the clinic and the results look normal. St. Jude Medical makes cardiac, neurological and chronic pain products.
• Veridex (Raritan, New Jersey) said that its licensing collaborator, Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina), has launched a new gene methylation test for prostate cancer. The new assay uses the biological specificity of DNA methylation' in prostate cancer, detecting the methylation of the gene GST-Pi. Methylation is a modification of DNA that occurs primarily in cancer. Veridex is making the methylation markers in this tissue assay, GST-Pi, along with other markers, for a urine-based screening test for prostate cancer. Veridex makes cancer diagnostic products.