• Medtronic (Minneapolis) received FDA approval to market the RestoreUltra neurostimulation system for the treatment of chronic intractable pain of the trunk and/or limbs (chronic back and leg pain). This rechargeable neurostimulator is the smallest and thinnest 16-electrode rechargeable neurostimulator available. The patient programmer used with the RestoreUltra system gives patients more control over their therapy than ever before. In addition, the RestoreUltra neurostimulator allows patients who use medium stimulation settings to go at least two weeks before needing to recharge. Medtronic’s neuromodulation business offers innovative therapies for chronic pain, movement disorders, spasticity, overactive bladder, benign prostatic hyperplasia and gastroparesis.
• Multi Radiance Medical (Solon, Ohio), in partnership with Rich-Mar (Chattanooga, Tennessee), reported the introduction of its new therapeutic laser, Laser Prism with area identification matrix and its FDA-cleared LaserStim accessory, to speed relief to chronic and acute pain sufferers. Laser Prism’s specially designed LaserStim accessory can provide simultaneous or independent light and electrical stimulation applications for superior clinical applications and outcomes. In addition to its proven pain-relieving qualities, physical therapists and chiropractors can now be reimbursed for the time spent administering light therapy. The LaserStim is a combination emitter that uses multiple radiances, including a super-pulsed laser with 25,000 milliwatts of peak power, red LEDs, infrared and static magnetic field, with electrical stimulation to promote an optimal healing environment. Laser Prism and LaserStim provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm. Rich-Mar specializes in ultrasound, electrotherapy, and light therapy modalities. Multi Radiance Medical makes devices using multi radiance technology.
• Toshiba America Medical Systems (TAMS; Tustin, California) reported FDA clearance for its new open-bore 1.5T vantage titan MR system. The company said the open-bore of the titan is 18% larger than other 1.5T systems on the market, featuring a large 71-cm patient aperture. The system features Toshiba’s Pianissimo noise reduction technology, designed to create better imaging. The titan also uses Toshiba’s contrast-free MRA techniques – fresh blood imaging, contrast-free improved angiography, time-spatial labeling inversion pulse, and time-slip angiography. TAMS makes magnetic resonance technology.
• Valor Medical (San Diego) said that it has received approval for the first clinical trial in Europe for Neucrylate, a liquid injected into a cerebral aneurysm through a micro-catheter placed from the femoral artery. When Neucrylate comes in contact with blood, the liquid changes into a solid material similar to a sponge. The surgical procedure for injecting Neucrylate will take less time, yet offers a more complete filling of the aneurysm as compared to coiling. Valor is an emerging company that has developed an injectable device for the treatment of cerebral aneurysms.
• Volcano (San Diego) reported FDA clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 imaging system as Volcano’s previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools — all on the same integrated IVUS platform. Earlier generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform. Volcano specializes in intravascular ultrasound and functional measurement technology.
• Welch Allyn (Skaneateles Falls, New York) introduced the Digital MacroView Otoscope, a hand-held video otoscope with USB connected, plug-and-play capabilities that offers clear, live and still images of the ear canal and tympanic membrane—improving communication and patient compliance. The Digital MacroView Otoscope has the ability to focus the image for clear views, comes equipped with an insufflation port for pneumatic otoscopy, and works with all existing Welch Allyn 3.5V power sources.