Clinical Studies/Trials

The first patient has been enrolled in a Boston Scientific Corporation (NYSE: BSX) study comparing the WallFlex® Biliary RX Fully Covered self-expanding metal stent (SEMS) to plastic stents for the treatment of benign bile duct strictures caused by chronic pancreatitis.

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.

An orbital sander may sound like a slightly risky thing to be pushing through your average calcified plaque deposit, but following a successful first study, Cardiovascular Systems has now completed enrollment in a second, US-based study in coronary artery patients.

Less than two months after giving Sunshine Heart the conditional approval to start its IDE study of the effectiveness of its C-Pulse® system in alleviating the condition of heart failure patients, the agency has now rubber stamped the study by removing the conditionality.

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, has announced the completion of enrollment in the Tryton Pivotal IDE trial evaluating its Side Branch Stent.™

Registry data collected from patients undergoing treatment with Wingspan under US Humanitarian device exemption approval has resulted in FDA issuing more limited indications for use. Yet in Europe we seem to be burying our heads in the sand on the device’s shortcomings.

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.

J&J subsidiary, Cordis has seen its Incraft AAA stent graft study results reach 1 year with no problems and 100% efficacy. The graft, with its 13Fr delivery system aims to extend EVAR To More Patients than currently indicated.

At TCT 2012, Volcano Corporation announced results from the largest study of its kind, showing that stent procedures guided by intravascular ultrasound resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.

Gore REDUCE Clinical Study investigators implored to continue enrollment, and drive ‘Diligent Continuation of Study’ in an effort to generate PFO data that principals believes will be significant if inclusion and exclusion criteria are adhered to and clinical bias reduced.

Abiomed’s Impella® devices are fiendishly clever little pumps for use in heart failure patients. The company has now received FDA approval to commence an IDE study on its new Impella RP device which it hopes will pave its way to U.S. humanitarian device exemption.

UK vascular device specialist Veryan Medical has developed a stent design technology which aims to mimic the helical shape of peripheral vessels in the hope that this will have a vasoprotective effect and furthermore reduce risk of deformation and vessel trauma during leg flexion.

More good news for Biotronik’s peripheral vascular business as its Pulsar 18 study gets underway in the U.S., hot on the heels of favourable clinical study results from Europe.

Clinical study results show strong evidence of benefits for lower limb intervention when using Pulsar stents, with no statistical difference between heavily calcified and non calcified lesions.

An article in November’s Ophthalmology talks about ultra-small drainage devices for use in facilitating drainage and therefore reducing intraocular pressure in some glaucoma patients. Results presented at AAO meeting this week suggest the Ivantis Hydrus microstent is clinically effective.

Boston Scientific Corporation and the University of Rochester Medical Center have shown that improved programming of Boston Scientific dual-chamber ICD or CRT-D heart devices can reduce inappropriate therapy and risk of death.