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.
Intuitive Surgical has written to customers worldwide, and in the US the FDA has issued a Class II recall notice which contains the instruction that users should contact the company to arrange an inspection visit and repair or replace daVinci robotic surgery device components as necessary to avoid a friction-induced stalling problem.
Biotronik, a pioneer in MRI compatible Cardiovascular implants devices, tells us that the US FDA has approved an expansion of its ongoing ProMRI® trial. This will allow inclusion of additional patient cohorts into the study, providing further support for the company's proposed claims.
Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive's da Vinci system, as reported on the FDA's MAUDE database, were either a result of operator error or technical failure of the robotic system itself.
Italian Cardiovascular device company Sorin has confirmed that it has gained CE Mark approval and seen a first implant of the KORA 100 pacing system, which is MRI compatible.
German "tablet" ultrasound specialist eZono AG, has received CE marking for its eZono 4000 system, with eZGuide, a revolutionary needle guidance technology.
Last week we covered the news that Italian cardiovascular outfit Sorin had gained CE mark approval for its Solo Smart stentless heart valve. Now the company tells us it has also gained the European nod for the large sizes of its sutureless Perceval valve.
The US FDA has cleared V.A.C.®Via™ Negative Pressure Wound Therapy System from Kinetic Concepts, Inc., featuring a diaphragm pump for faster draw down, longer battery life and higher leak rate threshold than its forebear.
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the US FDA has said in a new safety communication for users of these previously recalled devices.
When companies call themselves global, it's usually a description of all the places they sell to or in, or it's an aspiration. Either way, Thanksgiving reminds us that when the US has a day off, it all goes a bit quiet.
A division of GC Aesthetics, Nagor is the only breast implant manufacturer based in Britain. And in a piece of elegant commercial symmetry it has just announced that it is now launching its range in France, no doubt hoping its quality message and reputation will score heavily in the aftermath of a certain other silicone breast manufacturer.
BioMedical Enterprises (BME), Inc. has announced the FDA clearance of an upgrade to the patent-pending HammerLock® Nitinol Intramedullary Fixation System.
C.R. Bard has announced the submission of the final module to support FDA approval for the Lutonix® Drug-Coated PTA Dilatation Balloon/Catheter. This could put it at the front of the queue of companies hoping for a first peripheral drug coated balloon approval.
These two OR household names have agreed to buddy up at a sales level. While coordinating their collective devices into one "turnkey" OR system makes a lot of sense, it'll be interesting to see how their non-exclusive sales agreement works out in the field.
Boston Scientific has followed its July CE mark approval of the Promus Premier drug eluting stent, with a newly announced FDA approval. The company claims "next generation" status, based on enhancements in stent design and delivery system.