Pain management

St. Jude Medical, Inc., has initiated a clinical study of the Prodigy™ neurostimulator, the first spinal cord stimulation (SCS) system able to deliver a proprietary mode of stimulation therapy called burst stimulation. The SUNBURST™ study will evaluate whether burst stimulation can be more effective in managing chronic pain than traditional tonic stimulation.

Spinal Modulation, Inc., has announced the first patient enrollment in its U.S. pivotal clinical trial. The ACCURATE Study is a … continue reading “First Patient in U.S. Pivotal Study of Axium™ Neurostimulator System for Chronic Pain”

Biomedical technology company SetPoint Medical,developing neuromodulation therapies for inflammatory diseases, has secured $27 million in financing from its current investors along with new investors who’s names you might recognise.

NeuroMetrix, Inc., a medical device company focused on the treatment of the neurological complications of diabetes, reported that the SENSUS Pain Management System has become the first transcutaneous electrical nerve stimulator to receive FDA 510(k) clearance for use during sleep.

Medtronic has recently issued four Field Safety Notices (FSN) related to the SynchroMed II and SynchroMed EL implantable drug pumps and accessories. These have been wrapped up into one Device Alert by the UK’s MHRA regulatory authority.

An FDA Class I recall has been issued because certain Symbios Pain pumps may have excessively high flow rates with the attendant risk that medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity.

St. Jude Medical, Inc. has made a $40 million equity investment in Spinal Modulation, Inc., a company that has developed … continue reading “St. Jude’s “Try Before You Buy” Deal With Spinal Modulation, Inc.”

Drug delivery device company Carticept Medical, Inc., has received FDA 510(k) clearance to market its enhanced Navigator® Delivery System (DS). Navigator DS is the first and only FDA-cleared, computer-controlled injection system intended to increase the efficiency, comfort, safety and accuracy of musculoskeletal injections.

Boston Scientific Corporation has received U.S. FDA approval for its Precision Spectra Spinal Cord Stimulator System. The company is now beginning a limited launch of what it says is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts.

The FDA has issued its highest classification of recall for the Symbios Medical GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076. There is a risk that the flow restrictor bead could become dislodged, resulting in a high rate of flow.

Smiths Medical has announced FDA 510(k) clearance for its CADD®-Solis VIP ambulatory infusion system with CADD™-Solis medication safety software. This multi-therapy pump includes applications from TPN to chemotherapy, antibiotics, hydration and pain management with intuitive, easy to use navigation and features inbuilt safety measures.

Medtronic, Inc. has announced the start of PROMISE, the first ever, large-scale study comparing the effectiveness of its neurostimulation therapy plus optimal medical management to optimal medical management alone in failed back surgery patients.