Clinical Studies

Research presented at last week’s ESC suggests Heartlight may deliver more durable PV isolation vs Cryoballoon ablation.

The first patient has now been enrolled in the Biotronik-supported study which aims to identify risk factors that can help predict appropriateness of ICD interventions.

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.

Maquet Cardiovascular has issued a press release pointing us to the publication at ESC of clinical data which says its intra-aortic counterpulsating balloon shows observable 30 day reduction in mortality. The study size dictated that a 12% reduction was required in order to demonstrate significance, a target which was not reached.

The first clinical trial resulting from NICE medical technology guidance recommendations is due to start soon on a device to promote wound healing.

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).

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”

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.

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.

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).

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.

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.

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.

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.

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.