Cardio

Biotronik ticks another big box with the FDA clearance of its Lumax 740 ICDs and CRT-Ds equipped with home monitoring, supporting the company’s claim to have the only CE and FDA approved remote cardiac patient management system for early detection of clinically relevant events.

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.

Medical Devices industry, technology and clinical happenings from the week just passed.

St.Jude Medical’s Bi-Annual Product Performance Report highlights positive results for its Optim coated leads, while also accepting an ongoing problem with older Riata products.

Hong Kong Doctor Wing-Hong Fung has performed the first Asian implant of Biotronik’s MRI compatible ICD, a device which acknowledges that heart patients may also need MRI at some point.

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.

Which ever technology the future of atrial fibrillation therapies lies in, this new report from UK consulting firm Cambridge Design Partnership claims to have it covered. And its available on request!

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.

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

New CRT device from Biotronik gives heart failure safe access to MR scans and can be remotely monitored too.

Beautiful kids make great poster girls for campaigners trying to cut regulatory red tape and speed new technologies to market. But will the balance between too strict and too lax ever end up as “aaah, just right”?

Champagne corks will be popping at Cameron Health as FDA’s expert panel review results in a vote in favour of its subcutaneously implanted S-ICD® device. FDA approval is expected to follow within 12 months.

Heartware’s Ventricular Assist Device was expected to get the FDA Circulatory Systems Advisory Panel support, so it’s no surprise that it’s happened. FDA approval is expected to follow.

April 26th is FDA Circulatory Panel decision day for Cameron Health’s S-ICD device. Not much resting on it… only $150m.

Boston Scientific is having a good week, not least with the news that its super fine Emerge PTCA balloon catheter has gained its CE Mark.

More pacing leads from St.Jude are now at risk of externalisation according to a new MHRA medical device alert.