Clinical Studies/Trials

Edwards Lifesciences’ Sapien XT may not be FDA cleared, but in Europe at least the company is generating a nice body of data suggesting that at least in the short term the valve performs well in high risk patients. These data have been presented at EuroPCR 2012 in Paris this week.

It’s EuroPCR week, so cardiothoracic companies are timing their press announcements to coincide with the event. Californian company Elixir Medical’s fully bioabsorbable drug eluting coronary scaffold has been the subject of what looks like a very promising clinical study presented during the event.

Dual anti-platelet therapy is normally required for 6-12 months after implantation of a stent, with associated risks, costs and general inconvenience. No wonder then that Abbott is sounding pleased with itself as it gains the first indication of its kind to reduce the therapeutic period to a minimum of 3 months based on data from 10,000 patients.

EuroPCR is being held in Paris right now and is the European focal point for all things cardiovascular. St. Jude Medical, Inc. has chosen the event to announce CE Mark Approval and launch of its EnligHTN™ renal denervation system.

Boston Scientific Corporation has issued an announcement confirming CE Mark approval and European market launch of the Innova™ Self-Expanding Bare-Metal Stent System, which is designed to treat peripheral vascular lesions in arteries above the knee.

Direct injection of stem cells and other biotherapeutics into the myocardium is quite a hot topic, so the announcement of an optimised injection catheter must be well timed.

Zephyr Endobronchial Valve (EBV) therapy guided by Chartis Assessment is effective in a broad range of patients according to a new study, published in the European Respiratory Journal and flaunted by pulmonology company Pulmonx.

St.Jude clearly wants to remind its audience that it’s a company at the forefront of cardiac electrophysiology, and has timed a flurry of good news press releases to coincide with Heart Rhythm 2012.

Edwards Lifesciences is trumpeting the newly released results from a study of its Intuity Valve System, which suggests small incision surgery is fast, safe and clinically effective.

Echo Therapeutics is trumpeting clinical results from its transdermal glucose monitoring system which has been performed at Tufts Medical Center, Boston Mass. The study concerns use in an intensive care setting and the investigating clinicians seem impressed.

The wonders of effective PR. Either that or RhinoChill® is taking off all on its own merits as this innovative portable brain cooling system receives coverage in all the right places. The concept of brain cooling for heart attack patients, taken right to the front line.

Californian company Vessix Vascular Inc has announced the CE marking of its rather clever RF balloon for renal denervation. The company claims its approach means faster treatment than the other systems on the market and its clinical performance will shortly be presented at the EuroPCR Conference in Paris May 15-18.

Accuray takes on da-Vinci in the quest to establish the gold standard of treatment for early stage localised prostate cancer. Ten year multicentre study announced.

More positive signs for Medtronic’s Renal Denervation System as clinical trial results suggest sustained and significant blood pressure reduction.

GI Dynamics Inc is no doubt delighted to see its product featuring at the Obesity and metabolic Disorders congress, especially as a presentation suggests its Endobarrier® device can be used a second time on the same patient without problems.

Single study shows novel hydrogel scaffold results in better wounds. Product gets CE mark. Should it really be that simple?