StimGuard said today it won CE Mark approval in the European Union for its sacral nerve stimulator designed to treat intractable symptoms of overactive bladder, with plans to launch the device in the EU this summer. The Pompany Beach, Fla.-based company touted that the StimGuard SNS system can be implanted through a needle without a surgery, […]
StimGuard launches head-to-head trial against Medtronic’s InterStim
StimGuard yesterday announced plans for a clinical trial comparing its nerve stimulator with the InterStim sacral nerve stimulator made by Medtronic (NYSE:MDT). Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve […]
StimGuard launches OAB neurostim trial
StimGuard said today it enrolled the 1st patient in a clinical trial of its StimGuard miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The Fort Lauderdale, Fla.-based company’s system is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve and treat the […]
SuperSonic Imagine CEO Egelund out after 8 months | Personnel Moves
SuperSonic Imagine said today its CEO Tom Egelund, only appointed as chief in April, will be replaced by supervisory board member Bernard Doorenbos who will operate as interim president and CEO. Doorenbos has held positions at Philips, Thomson CSF, Signaal USFA and acted as CEO of molds and plastic component company Axxicon Group NV, Neways Electronics […]
StimGuard wins another IDE nod for bladder treatment trial
StimGuard said it won another FDA Investigational Device Exemption to run a clinical trial of its percutaneously implantable device to treat urgency urinary incontinence as a result of refractory overactive bladder syndrome. The StimGuard device utilizes a 1.3mm microchip neurostimulator designed to be implanted non-surgically with a needle. The stimulator communicates with a small external […]
FDA OKs trial for StimGuard’s bladder implant
StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
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