It’s was SNIS 2012 last week, the annual meeting of the Society for Neurointerventional Surgery. Neuro device company Nfocus Neuromedical, Inc., used the occasion to announce positive data from an ongoing clinical study of the company’s Luna Aneurysm Embolization System (AES).
Clinical Studies
Should St.Jude’s CEO Have Used The “F” Word In Hinting At PFO Study Results?
St.Jude’s CEO Dan Sparks used the word “favorable”(sic) to describe the outcome from its giant study into whether closure of a patent foramen ovale using the company’s Amplatzer device has a positive impact on incidence of cryptogenic stroke. Some commentators are suggesting he should have kept schtum until the clinical results are published later in the year.
Study Says Using PediGuard® In Pedicle Screw Placement Reduces Radiation Exposure From Fluoroscopy By 30%
SpineGuard, the company with the stated mission of making spinal surgery safer, has announced that data accepted by Spine and published ahead-of-print online demonstrates that the Company’s PediGuard® device reduces spine surgeons’ radiation exposure from fluoroscopy by 30% while maintaining a 97.5% accurate placement of pedicle screws during lumbar spine fusion.
Biotronik Announces First CRT-D Patient In Remote Patient Management Study
Biotronik has announced that the first cardiac resynchronisation therapy device (CRT-D) patient has been enrolled in its so-called EuroEco Trial—the European Health Economic Trial on Home Monitoring in implantable cardioverter-defibrillator (ICD) and CRT-D patients.
Atrial Fibrillation: Dawn Of A New Age Or Too Early To Tell?
US researchers have found that the irregular heart rhythms of atrial fibrillation are caused by small electrical localised sources or “hotspots” inside the heart called focal impulses or rotors. Now they can map these rotors and ablate them with a degree of accuracy which seems to render results which are twice as good as previously achieved.
Six Month Follow-Up Suggests XPED Pedicle Screw May Outperform “Standard Pedicle Screws”
Expanding Orthopedics’ innovative pedicle screw system saw its 12 month clinical study published as an e-poster at SRS last weekend. Despite not being a comparative study, results from the ten patients suggest the device may offer earlier pain reduction and improved clinical outcomes compared with standard pedicle screws.
Riata: St. Jude’s Study Shows Same Problems as Other Studies
St. Jude Medical, Inc., has gone public with initial findings from its Riata Lead Evaluation Study. The study’s phase-one results found that externalised conductors occurred in 9.3 percent of the smaller-diameter Riata ST 7F leads in the study, and in 24 percent of the larger-diameter Riata 8F leads.
FDA’s Green Light For Heart Failure Study Using CardioFit® Vagus Nerve Stimulation System
Israeli company BioControl Medical has announced U.S. FDA approval to begin the second phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-centre, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure.
CE Mark For MEDIHONEY® HCS Coincides With BMJ Paper Supporting Honey Application In Acute Wounds
In one of life’s pleasing little coincidences a newly published meta-review of wound care studies has, among its conclusions, established that topical honey reduces wound healing time when compared to film or gauze-based dressings for burns. Derma Sciences, Inc., with perfect timing has announced the CE Marking for its patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings, containing (you’ve guessed it), honey.
Sorin’s Multi-Centre Sleep Apnea Monitoring/Pacemaker Study Starts Enrollment
New Sorin study evaluates sensitivity and positive predictive value of Sleep Apnea Monitoring (SAM) feature in implantable pacemakers.
In-Vivo Tests Start For New Drug-Eluting Balloon Designed to Increase Drug-in-Tissue Concentration
For a drug-eluting balloon to be effective the drug needs to elute at the right rate, which German company cardionovum believes is fast. Newly commenced in vivo studies will no doubt confirm the assertion.
EmbryoGlue® Improves IVF Pregnancy Rate, Independent Of Endometrial Preparation
Endometrial preparation does not seem to impact on success of EmbryoGlue, from Swedish fertility company Vitrolife, as study presented at ESHRE conference shows significant pregnancy rate improvement in all cases.
Is There A Rat To Smell In Medical Journals’ High Reprint Orders?
Richard Smith says it’s time to open up the finances of medical journals so we can see whether lucrative reprint business is risking clouding judgement. A bit more transparency about publications’ sources of income would perhaps provide comfort.
New Study Will Investigate Potential Of Retrograde Endovascular Approach To Occluded Lower Limb Arteries
A new technique involving retrograde endovascular approach to occluded peripheral arteries shows promise, but hasn’t yet been formally studied. Cook Medical is supporting a multicentre effort to build an evidence base for what could be a promising solution to the major healthcare problems resulting from peripheral artery disease.
Clinical Results Suggest EndoBarrier® Therapy Is Effective In Overweight And Mildly Obese Type 2 Diabetes Patients
More clinical evidence, presented last week, supports GI Dynamics’ case that its EndoBarrier® gastrointestinal lining device represents an effective therapeutic option in overweight and mildly obese type II diabetic patients.
FDA Chooses Medtronic Stent Graft For Early Feasibility Study Initiative
US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.