The first clinical trial resulting from NICE medical technology guidance recommendations is due to start soon on a device to promote wound healing.
Clinical Studies/Trials
Biolimus-Eluting Stent vs BMS Shows Lower MACE Rate For STEMI Patients
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).
CardioFocus To See HeartLight® Data Presented At ESC Congress 2012
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.
InSightec Receives FDA Approval To Begin Phase I Parkinson’s Trial
InSightec Receives FDA Approval to Begin Phase I Parkinson’s Trial (via PR Newswire) TIRAT CARMEL, Israel, August 20, 2012 /PRNewswire/ … continue reading “InSightec Receives FDA Approval To Begin Phase I Parkinson’s Trial”
Medtronic’s Newly CE Marked Cardiac Resynchronisation Therapy Devices Preserve Normal Heart Rhythm
Medtronic has announced CE mark approval for two new CRT devices which automatically adapt to patients’ electrical rhythms, improving response to life-saving therapy.
InspireMD Hints At Positive Results From MGuard™ Stent Trial
It’s a right old game isn’t it? Issue a press release when the study’s announced, another when enrollment’s complete, another suggesting the results are good (this one) and finally another when the results are published in October. And what does a “positive outcome” suggest? No worse? Marginally better? Much better? Stupendously better? Whatever, it’s a fine example of squeezing the PR pips out of a clinical study.
510(k) Clearance For Stryker’s Trevo® Pro Clot Retrieval System
Stryker Neurovascular’s Trevo® Pro Retriever has gained FDA 510(k) market clearance. The Trevo® Pro Retriever outperformed Stryker’s own Merci® Retriever in a clinical study first published in May, showing improved revascularisation compared with the older generation product.
Study Suggests Human Amniotic Membrane Product Dramatically Enhances Diabetic Foot Ulcer Healing
MiMedx Group Inc., manufactures Epifix®, a wound treatment based on processed Human Amniotic Membrane. In a prospective randomised controlled study it appears the product significantly improves the healing rate of diabetic foot ulcers compared with standard of care only, to the extent that the trial was terminated early.
Berlin Heart’s EXCOR® Pediatric VAD Outperforms ECMO Bridging Therapy In Heart Transplant Candidates
A new study published in the current issue of the New England Journal of Medicine (NEJM), concludes that survival using the Berlin Heart’s EXCOR® Pediatric Ventricular Assist Device (VAD) as a “bridging therapy” for children in need of a heart transplant is “significantly greater” than the standard-of-care ExtraCorporeal Membrane Oxygenation (ECMO).
How Can Stryker’s Wingspan Neuro Stent Maintain Broad CE Mark In Europe When U.S Study Results Have Driven FDA To Restrict It’s Use?
The consequences of our distinct regulatory set-ups is that sometimes study information that drives indications for use one side of the pond is ignored on the other, despite the fact that it may have significant clinical consequences as seems to be the case with Stryker’s Wingspan Neurovascular Stent.
First Patient In Deep Brain Stimulation For Alzheimer’s Study
A first patient has been successfully implanted with Medtronic’s DBS device as Functional Neuromodulation Ltd initiates the ADvance Study in the U.S. and Canada to assess the therapy in patients with mild Alzheimer’s disease.
FDA Approves Abbott’s Omnilink Elite® Vascular Balloon-Expandable Stent System For Treatment Of Iliac Artery Disease
Abbott has announced U.S FDA approval for its Omnilink Elite® Vascular Balloon-Expandable Stent System for the treatment of iliac artery disease. The stent, already CE marked and marketed in Europe, has passed muster with the FDA following a comparative multicentre clinical study which suggested it outperforms endpoints established from previous stent studies..
First-In-Human Use For ART’s Bioresorbable Stent
ART reckons its bioresorbable coronary stent will disappear in a predictable timeframe because of its “programmed transitory presence”. Despite the sci-fi language it sounds like a smart product if it works… time will tell as the company undertakes its first in man clinical study.
Malignant Melanoma Detection’s Game-Changing Technology, According To Study Results
Swedish medtech company, SciBase, has announced positive results from its pivotal study of Nevisense, a unique non-invasive point-of-care device for detection of Malignant Melanoma.
First Retrospective Head-to-Head Fusion Rate Study For TranS1’s AxiaLIF®
Results from the head-to-head retrospective study comparing TranS1’s AxiaLIF® with the ALIF approach to lumbar interbody fusion have been announced and while suggestive of an advantage for the AxiaLIF device, results are not significantly different.
TAVI: Edwards Counters Researchers’ Claims
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?