• CoAxia (Minneapolis) said that investigation of its NeuroFlo perfusion augmentation technology has been extended to patients who do not respond to thrombolysis with the drug tissue plasminogen activator (tPA), the only stroke therapy currently approved by the FDA. Already being evaluated as a stand-alone treatment for patients that are outside the three hour tPA treatment window, NeuroFlo cerebral perfusion augmentation was successfully performed for the first time on a patient who had previously received tPA by the stroke team at University of Alberta Hospital in Edmonton, Alberta. The NeuroFlo treatment is intended to deliver increased blood flow to the affected, but still salvageable, area of the brain in stroke patients by increasing flow via collateral pathways "around" a blocked artery. The therapy is accomplished with a unique, dual-balloon catheter that creates a partial occlusion of the descending aorta and redirects blood flow to the brain. CoAxia is a venture-backed, privately held, development-stage company focused on providing perfusion augmentation therapies that improve outcomes for patients with cerebral ischemia resulting from stroke, vasospasm and other conditions.

• Cochlear Americas (Denver) reported on the availability of three new pediatric solutions designed to enhance the hearing experience of Cochlear's youngest implant users: Babyworn accessory pack + Babyworn cable, and the behind the ear (BTE) tamper-resistant battery holder and removal tool. Babyworn is ideal for children with small ears as it reduces the BTE size and weight. Babyworn provides two flexible wearing options: a single controller-standard BTE configuration and an upper body configuration. The Freedom Snugfit consists of an upper ear hook, main body and lower ear hook; it keeps the sound processor in place. Cochlear Americas makes products to help hearing-impaired individuals across the globe.

• CoorsTek (El Segundo, California) reported the USP Class VI approval for one of its advanced polymers used in pharmaceutical and biomedical applications. Dubbed Tetralon 240, the material is primarily used in high-performance seals and bearings where long component life and low friction are critical. Product testing revealed Tetralon 240 polymer features a low coefficient of friction (0.15 to 0.2 @ 33.3 PSI, 150 FPM), durable tensile strength (5,500 psi using ASTM D4894 test), and a low deformation under load at 8.0% (ASTM D621). CoorsTek makes technical ceramics and PTFE-based polymer seals and components

• Conceptus (Mountain View, California) reported the approval of its third generation Essure permanent birth control system by the FDA. System modifications include changes to the delivery system that reduce the number of steps a physician is required to perform during a placement procedure. A new DryFlow Introducer, which alleviates distension fluid loss, a major safety concern of hysteroscopists, is packaged with the product. The company said the Essure procedure remains the only FDA approved female sterilization procedure to have zero pregnancies in the clinical trials. It is a sterilization procedure that replaces tubal ligation for women. A soft micro-insert is placed into the fallopian tubes through the cervix using a hysteroscope. Once in place, the device is designed to elicit tissue growth in and around the micro-insert to form an occlusion or blockage in the fallopian tubes, over three months. An Essure procedure does not require cutting into the body and can be performedin the doctor's office, a less costly procedure setting, with just a local anesthetic. A woman is able to leave the office about 45 minutes after the procedure is completed.

• DePuy Spine (Raynham, Massachusetts), a Johnson & Johnson (New Brunswick, New Jeresy) company, reported that Cigna, one of the nation's largest health insurers, will now cover artificial disc replacement for single-level degenerative disc disease. Cigna, which provides health insurance to about 47 million people, joins Aetna, Kaiser Permanente, Horizon Blue Cross Blue Shield and dozens of regional insurers, in covering the surgical implantation of the Charité disc for low back pain and disability from degenerative disc disease. The Charité, made of two metallic endplates and a polyethylene sliding core, is designed to replace a worn out or damaged spinal disc. Spinal discs maintain the position of the spine and allow for bending. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease at one level from L4 to S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have no more than 3mm of spondylolisthesis at the involved level. Patients receiving the device should have failed at least six months of conservative treatment prior to implantation.