December 11, 2015

FDA Clears Spinal Cord Stimulation System

Wireless medical devicemaker Stimwave Technologies has scored FDA clearance for its Stimwave Freedom-8A Spinal Cord Stimulation System for treatment of chronic back and leg pain. The wireless, micro-technology neuromodulation system features eight-electrodes placed near surrounding nerves, to which the miniature device delivers small pulses of energy. The system previously received FDA clearance for its four-electrode device last year. Stimwave has also begun marketing the device, and a nationwide launch is expected in January 2016.

Medtronic Gets Approval for Neurostimulator

The FDA has given the green light to Irish devicemaker Medtronic for systems within its Activa portfolio of deep brain stimulation neurostimulators for full-body MRI scans. Previously, patients with Medtronic DBS could receive head scans at a low radiofrequency power limit, and the DBS system had to be turned off prior to the MRI scan. The approved full body MRI and higher power limits enable improved image quality, faster scan times and larger scan coverage for better diagnostic capabilities. According to the devicemaker, its MR Conditional DBS systems are the only approved for full-body MRI scans.

FDA Grants 510(k) Clearance to Qfix

The FDA has awarded radiotherapy devicemaker Qfix 510(k) clearance for its Encompass SRS Immobilization System for stereotactic radiosurgery. The device is cleared for sub-millimeter immobilization to treat multiple lesions with a single isocenter. The system uses a posterior thermoplastic and anterior open view mask compatible with optical tracking systems. It also features an optional IntegraBite, which can reduce motion to enable maximum exposure to the tumor while minimizing radiation delivery to surrounding healthy tissue. The device is currently used for intracranial radiotherapy treatments.

Allurion Technologies Wins CE Mark

Wellesley, Mass.-based Allurion Technologies has won CE mark for its Elipse Gastric Balloon for obesity. The swallowable balloon — made of thin, flexible polymer film — fills the stomach and assists patients in feeling full and eating less. It remains in the stomach for four months, before automatically emptying and being naturally excreted. The device will initially be available in weight loss centers in France, Italy and the UK, and eventually the Middle East, according to the company. The product is not approved in the U.S.

FDA Clears RevMedX’s Wound Dressing

The FDA has given its blessing to RevMedX’s XSTAT 30 wound dressing to treat adults and adolescents in the general population. The expandable, multi-sponge dressing — used to control life-threatening bleeding from wounds in areas that a tourniquet cannot be placed, such as the groin or armpit — was previously only cleared for military use. It is indicated for patients at high risk for immediate, life-threatening and severe hemorrhagic shock and non-compressible junctional wounds when care at emergency rooms is not available within a few minutes.