December 4, 2015

St. Jude Launches SCS System in Europe

St. Jude Medical has launched its Proclaim Elite spinal cord stimulation system — a non-rechargeable system designed to deliver burst stimulation — in Europe. The approval includes conditional magnetic resonance, enabling patients to safely undergo head and extremity MRI scans. The device doesn’t need to be recharged and features Bluetooth wireless technology and Apple mobile digital devices to allow for more effective management of chronic pain treatment. It also is equipped with an upgradeable platform, so patients can more easily access future therapies and software upgrades.

New Director Starts at Croatia’s Agency

Sinisa Tomic began a four-year term as the new director of the Croatian Agency for Medical Products and Medical Devices on Dec. 1. He was chosen for the position on Nov. 25 by the agency’s governing council. Tomic served as head of the agency from October 2003 to November 2011.

Covalon Wins Clearance for Catheter

The FDA has granted Covalon Technologies clearance for its SilverCoat Silicone Foley catheter, which is designed to allow clinicians to drain a patient’s bladder. By draining the bladder, the catheter helps reduce the likelihood of a patient developing a catheter-related urinary tract infection. The U.S. Centers for Disease Control and Prevention taps catheters as the primary cause of urinary tract infections. The 100 percent silicone catheter features a permanent lubricious coating with silver ions, which provides a zone of inhibition to bacteria around the catheter surface. The silver also resists microbial colonization on the device’s surface, the Canadian company says.

FDA Approves Boston Scientific Catheter

Boston Scientific has won FDA approval and CE Mark for its AngioJet ZelanteDVT thrombectomy catheter designed to treat deep vein thrombosis in large-diameter upper and lower limb peripheral veins. The catheter is built to remove large venous clots and facilitate rapid restoration of blood flow, providing four times the thrombus removal power of existing AngioJet catheters, the company says. Deep vein thrombosis occurs when a blood clot forms in one or more of the deep veins — frequently in the legs. The device is designed to break apart and remove these clots from iliofemoral and lower extremity veins greater than or equal to 6.0 mm in diameter.

HiberGene Wins CE Mark for Test

Dublin, Ireland-based HiberGene Diagnostics has won CE marking for its HG Meningococcus test for Meningococcal disease, a severe form of bacterial meningitis. While current testing methods of growing the bacteria in a culture medium can take several days, HG Meningococcus — featuring loop-mediated isothermal amplification — provides results in less than an hour, the company says. The test can be performed using a sample of whole blood, cerebrospinal fluid or from a nasopharyngeal swab. The test will be available through a number of national distributors.