• Aragon Surgical (Palo Alto, California) reported receiving FDA clearance enabling laparoscopic surgeons to use the company's LapCap with any length needle, and allowing the LapCap to be used across the patient obesity spectrum, including in morbidly obese patients. The initial step in laparoscopic surgery requires instillation of gas into the abdominal cavity, creating the space in which the surgeon operates. To instill the gas, the surgeon blindly passes a 14 gauge needle through the abdominal wall, attempting to position the needle tip based only on tactile feedback. Aragon says that blind needle passage is associated with risk of needle injury to intestines and vessels, failure to correctly position the needle and anxiety for the surgeon. The LapCap allows lsafe, rapid, and predictably passage of the Veress needle into the abdominal cavity. In a clinical trial, the LapCap initially allowed for correct needle positioning in 100% of patients, and there were no needle-related injuries. Aragon makes surgical devices.
  • Researchers at the University of Kentucky Sanders-Brown Center on Aging (Lexington, Kentucky) are launching an Alzheimer's screening clinical trial with Neuronetrix's (Louisville, Kentucky) brain scanning system, called Cognision. The study will involve brainwave assessments using a technology called event-related potentials (ERPs) to validate the performance of the Cognision system and demonstrate applicability in a primary care setting. Up to 100 Alzheimer sufferers and controls will participate over six to 12 months. Patients will wear an electronic headset which will record brain activity in response to an auditory stimulus. The data is then uploaded to an online database where a pattern recognition engine will correlate the ERP tests with known brainwave patterns.
  • Sequenom (San Diego) reported approval of a protocol by the Institutional Review Board (IRB) at San Diego-based Sharp HealthCare, clearing the way to begin patient enrollment in a study to assess the company's noninvasive cell-free fetal nucleic acid SEQureDx Technology for the detection of fetal aneuploidy, including Down syndrome, using a laboratory developed test (LDT). Unlike current standards of harvesting placental tissue cells as is required for chorionic villus, or entering the uterus to sample the amniotic fluid surrounding the baby as is performed with amniocentesis, SEQureDx technology extracts fetal nucleic acid material safely and comfortably from a blood specimen collected from the mother to determine the genetic status of the fetus.
  • St. Jude Medical (St. Paul, Minnesota) reported FDA and CE-mark approval of the QuickFlex left-heart leads, used in cardiac resynchronization therapy (CRT). They feature shorter tip and ring electrodes (used to conduct energy), reducing the length of the lead's rigid portions. The concept is that shorter electrodes may help the lead through bends in the heart's venous system that characterize the left side of the heart. The QuickFlex leads also include an S-shaped curve providing stability inside the vein once the lead is placed in the desired location. The smaller S-shaped curve, evaluated in the company's 1056T QuickSite lead clinical study, demonstrated a high implant success rate and low dislodgement rate, according to the company.
  • St. Jude Medical (St. Paul, Minnesota) reported FDA approval of software and firmware updates to the Merlin.net Patient Care Network (PCN). The new Merlin.net PCN 2.5 will expand availability of the system nationwide and provide physicians with improved options for remotely monitoring their patients with the most commonly-used St. Jude Medical implantable cardiac devices. The upgraded system includes enhancements to the Housecall Plus transmitter which patients use to convey data from their devices over phone lines to the central Merlin.net PCN data repository. The modifications offer a one-step procedure for data transmission, expansion of services to include the entire U.S. and the ability to accommodate patients with devices who travel out of the U.S., by allowing them to transmit data from overseas. Merlin.net PCN is an Internet-based central repository for patient device data that gives physicians immediate access to detailed information about device performance, allowing them to assess the patient and determine the level of care needed. Patients with implantable cardiac devices use the Housecall Plus transmitter to send data from their devices directly to Merlin.net PCN from the comfort of their own homes. St. Jude Medical specializes in making life better for cardiac, neurological and chronic pain patients.