Clinical Trials

Regulatory approval is one step closer with Boston Scientific’s announcement that its REPRISE I Clinical trial of the Lotus TAVR system has completed enrollment.

Biotronik is touting a new paper in European Heart publication, Europace, in which investigators across 57 study sites grade their devices as excellent in 80% of cases.

Crux’s Vena Cava Filter is looking like a winner with good investigator feedback and clinical results as reported at last week’s Society of Interventional Radiology meeting in San Francisco.

OrbusNeich has issued a news release about a clinical study which supports the company’s claim that its clever “pro-healing” stent technology results in a stent which can be indicated in STEMI patients.

Two studies presented at ACC 2012 suggest that Medtronic’s Symplicity System for renal denervation shows safe, sustained and significant blood pressure reduction in treatment-resistant hypertension patients.

ACC sees presentation of data from study in severe aortic stenosis patients treated with Edwards Sapien TAVR option. Results are reassuringly equivalent to open heart surgery, suggesting this may be an additional option in patients not suitable for major surgery.

Medtronic announces strong clinical outcomes for its Corevalve product at ACC meeting.

Clinical trial of minimally invasive spinal fusion system now enrolling in Europe.

AtriCure has gained FDA’s blessing to commence a study into the impact of its AtriClip Left Atrial Appendage exclusion device on stroke prevention.

Eight years after first European implantation Sorin’s Freedom Solo stentless pericardial aortic valve sees its first US patient.

Medtronic’s newly announced patient registry and heart failure studies will inform on the effectiveness of renal denervation.

Boston Scientific is sounding pretty pleased with itself as it publicises positive results from three major studies on its WallFlex® enteral stent family of products.

Patients who underwent coronary angioplasty with InspireMD’s MGuard coronary stent exhibited statistically significant improvement in microvascular reperfusion criteria compared with those treated with traditional bare metal stents (BMS).

Covidien’s stent-like clot retrieval device, SOLITAIRE FR, worked well enough in this randomised study to persuade the safety monitoring committee to end the trial early.

Covidien’s Everflex system, designed to treat long vascular lesions with a single stent, is the subject of an extensive clinical study, interim results of which have been released. The stent is already approved for use in Europe.

Medtronic gets a little closer to market (in USA) with the announcement that CoreValve’s extreme risk group enrollment is now complete.