Clinical Studies/Trials

Cook Medical has gained 510(k) clearance for its Evolution® Colonic Controlled-Release Stent. The new stent is used to palliate uncomfortable symptoms associated with colonic obstructions caused by malignant neoplasms and relieve large-bowel obstructions prior to colectomy procedures.

New Sorin study evaluates sensitivity and positive predictive value of Sleep Apnea Monitoring (SAM) feature in implantable pacemakers.

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.

Initial findings from new study suggest successful delivery of PICSO® catheter and administration of PICSO® treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first-three STEMI patients.

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.

MicroVention, Inc., has announced that enrollment has begun in the Hydrogel Endovascular Aneurysm Treatment (HEAT) clinical trial, a prospective randomised study of the use of coiling technologies to treat intracranial aneurysms.

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.

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.

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.

Impressive new data from a sizeable study population suggests that OrbusNeich’s clever pro-healing Genous™ stent may perform as well without dual antiplatelet therapy as it does with it.

A few days ago we covered the story of Claret Medical’s first-in-human study using its original CE Pro embolic capture device. At the time we felt there were a few unanswered questions, so went back to Claret for some more information. This after all is a very promising looking device with genuine patient welfare consequences.

A new clinical study suggests endoscopic ablation for Atrial fibrillation generates good results with a durable outcome and a short learning curve for operators.

We thought when we saw the approval for Edwards’ Sapien valve to be extended to include a further patient cohort, that it was a great case study into the difference between EU and US regulatory processes, given the five year approval gap between the continents. Seems we were not alone.

We seem to be writing about Renal Denervation every few weeks as the players unveil their latest approval of latest study result. So we thought it worth stepping back and considering the state of play for a moment.

Neurological protection against emboli following TAVI is highly desirable, so Claret Medical’s early clinical experience in which over 50% of filter deployments resulted in capture of debris is reason for optimism.

ReCor Medical has reported six-month follow-up data on eight patients who have been treated via renal denervation for their resistant hypertension with the company’s unique ultrasound-based system and the results are impressive with an average reduction in systolic blood pressure of 33mmHg.