Not to be outdone by Medtronic Inc. (NYSE:MDT), which touted CE Mark approval for its peripheral nerve stimulation technique, St. Jude Medical Inc. (NYSE:STJ) announced the Australian launch of its Epiducer neurostimulation therapy delivery system yesterday.
Neurostimulation, also called spinal cord stimulation, can help manage chronic pain that results from failed back surgeries. Mild electrical pulses travel from a neurostimulator to one or more leads near the spine to interrupt or mask pain signals on their way to the brain.
St. Jude’s Epiducer system, which gained CE Mark approval in May of last year, allows insertion of multiple neurostimulation leads through a single entry point, a procedure which usually requires several incisions. Epiducer is part of the company’s neuromodulation portfolio, which boasts the world’s smallest rechargeable spinal cord stimulator, according to the St. Paul, Minn.-based medical device maker.
Medtronic is also a heavy player in the pain management market with its Restore line of neurostimulation devices. Medtronic’s PNS device uses percutaneous leads to send electrical pulses to the peripheral nerves within the subcutaneous tissue in the lower back area, using Medtronic’s existing implantable neurostimulation systems, the company said. The Minneapolis, Minn.-based company also offers a line of neuromodulation devices to treat incontinence.
Boston Scientific Corp. (NYSE:BSX) nearly sold their neurostimulation division to Stryker Corp. (NYSE:SYK) late last year, but the Natick, Mass.-based medical device maker spiked the deal when the bid didn’t rise high enough. The company then doubled down on its pain management division with a $78 million buyout of Intelect Medical Inc., developer of the Guide deep-brain stimulation programming system. Boston Scientific won FDA clearance for lead anchors for its partially implantable Precision Plus PNS device in March.
Peripheral nerve stimulation using fully implantable systems are not currently cleared by the FDA for use in the U.S.
BridgePoint Medical Inc. announced 510(k) clearance from the FDA for its CrossBoss catheter and Stingray system for placing guidewires in preparation for stent intervention. The devices are now cleared for use against chronic total occlusions, where lesions completely block an artery and prevent blood circulation to critical areas of the heart.
Gen-Probe Inc. (NSDQ:GPRO) announced a bid for U.S. regulatory clearance for its Panther device, a fully-automated molecular testing system capable of a wide range of tests, including a Chlamydia and gonorrhea package. The system can handle 500 samples and deliver results for both Chlamydia and gonorrhea for each in 12 hours, according to the San Diego-based company.
Johnson & Johnson’s (NYSE:JNJ) Cordis Corp. subsidiary won FDA clearance for its ExoSeal vascular closure device, a bioabsorbable plug designed to close a femoral artery puncture site. The plug is made of polyglycolic acid, which metabolizes to carbon dioxide and water in 60 to 90 days from implantation. In clinical trials, ExoSeal performed better than manual compression, the company said.
Elixir Medical Corporation announced CE Mark approval for its DESyne drug eluting stent with bioabsorbable coating, which uses the proprietary Novolimus drug. The Sunnyvale, Calif.-based company initiated enrollment in clinical trials for DESyne in September of last year.
Maquet Cardiovascular won FDA clearance to market CARDIOROOT, which is now commercially available in the U.S. CARDIOROOT is a one-piece aortic graft for treatment of a diseased or damaged aorta. The device is designed to conform to the blood vessel’s natural shape. Maquet is just coming off another win. The company’s CARDIOHELP cardiac/respiratory device received 510(k) clearance in April.
Aptus Endosystems Inc. announced that it received CE Mark approval for its Aptus EndoStapling system, which mimics hand suturing in repair of abdominal aortic aneurysms. The device may be used with the Aptus endograft as well as Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts.