We’ve opined before about the weird regulatory divide that sees life-saving technologies withheld from U.S. patients while being freely available in Europe. It seems the clinical community shares the view,as one physician/author shows her frustration at the continued unavailability of Abbott’s MitraClip.
Collaborative research performed between the Universities of Edinburgh and Southampton has resulted in a material that combines a plastic scaffold with the potential for stem cell regeneration of bone. It’s hoped the development may result in an expanded ability to repair bone in the most traumatic fracture cases involving bone loss.
The C SAFE caesarean section safety device from Brolex has emerged pretty well from a piece in “Reviews in Obstetrics & Gynecology.” C SAFE received the highest number of perfect “5” scores in the history of “MedReviews – OB Product Reviews.”
Miracor Medical Systems GmbH has announced that the Journal of Interventional Cardiology has published the clinical results of 10 patients enrolled in its “Prepare PICSO®” non-randomised safety and feasibility study.
Misonix, Inc. designs, manufactures and markets innovative therapeutic ultrasonic products for spine surgery and other specialties. The company has been cited for its BoneScalpel™ which a panel of 5 Spine Experts says is the year’s most exciting technology for spinal surgery.
From January 2013 the BMJ will no longer accept clinical studies for publication without a commitment from the authors to provide anonymised underlying, patient-level data on request.
It seems renal artery disease is a bigger predictor of one’s demise than coronary artery disease, so it’s perhaps reasurring to see a paper claiming that stenting of the renal arteries is an effective measure in reducing blood pressure over a sustained period.
Compared with a bare-metal stent, the use of a stent with a biodegradable polymer that releases the drug biolimus resulted in a lower rate of major adverse cardiac events at 1 year among patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention according to a study in the August 22/29 issue of the Journal of the American Medical Association (JAMA).
Following promising early clinical data CardioFocus has announced that its technology will be highlighted in two presentations during the forthcoming European Society of Cardiology Congress in Munich.
Edwards Lifesciences was not likely to let a BMJ article go unanswered, so it’s unsurprising to see the purveyor of the Sapien transcatheter valve issuing a stout defence of the clinical evidence behind its baby. But as a clinician, what are you supposed to do?… wait until the body of evidence is so significant as to be incontrovertible, or use your own judgement within the confines of regulatory approval?
Belgian researchers have stirred up a hornets nest with their assertion that evidence for TAVI means its use should be more limited than is the case, and furthermore that we’re still not getting the whole picture.
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.
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.
Top universities really do churn out some brilliant work. In this case Stanford researchers have published on the use of coated gold nanoparticles which selectively find cancer cells and aid in their isolation for treatment, potentially improving accuracy with the benefit of minimising collateral damage and ensuring no cancer remains.
As public spats go, this one is going to take some beating. St. Jude is not looking like its in the mood to give up as it comes right back at Medtronic, Dr Hauser and Heart Rhythm.
View from the Med: Week 13 is a good read… as ever.