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A poor Q4 for Orthofix in its international markets, has meant that annual sales of approximately $462M are well below the projection of $472-475M made as recently as one quarter ago. U.S. business looks resilient however.

Heart assist device company Thoratec Corporation has announced that the U.S. FDA has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilising the HeartMate II® Left Ventricular Assist System.

Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic.

A therapy as potentially huge as renal denervation is bound to be tied up in claim and counterclaim, and downright confusion about who owns what. A new article tries to unpick it all.

Insulet Corporation, has gained 510(k) clearance to market what it’s calling the “next-generation” OmniPod® Insulin Management System, more than a third smaller and a quarter lighter than the original model

Paris-based ultrasound therapy specialist, Theraclion, has gained CE mark approval for its non-invasive treatment of breast fibroadenomas, a first in this indication. The company expects this treatment to benefit thousands of women.

Ah, that’s a clever idea. Attach an inferior vena cava filter to a central line and you can protect patients for whom anticoagulation is not an option, against the threat of venous thromboembolism. Following CE marking BiO2’s Angel™Catheter is being launched in Europe this week.

The FDA has decided non roller cardiopulmonary pumps will no longer be exempt from the PMA process, meaning that devices like Abiomed’s Impella will have to undergo further steps in order to stay on the market in the long term.

Medical professionals are always right. They must be, because we don’t bother to regulate their practices, let alone require formal centralised approval of new techniques prior to their introduction. Meanwhile the device industry is increasingly regulated. We ask whether this is all entirely the best way of doing things.

New data, presented at TCT 2012 from the ADVANCE registry, confirms that mortality rates with transcatheter aortic-valve implantation (TAVI) using Medtronic’s CoreValve have dropped steadily since the devices’ earliest clinical trials.

New Data Presented at the 24th Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium Show Sustained Blood Pressure Reduction and Safety with Symplicity™ Renal Denervation System in Patients with Treatment-Resistant Hypertension

And we thought the Eurocrat life was a dull one. Commissioner Dalli goes from issuing new medical device directives to resigning over alleged involvement in a Swedish tobacco legislation fraud case in a matter of weeks.

Stryker’s numbers look pretty solid compared with certain others. However a tough OUS sales environment, coupled with general downward pricing pressure especially in capital goods means the company has had to lower 2012 growth forecasts.

St.Jude and AorTech’s disputes are developing into an interesting story as the two parties home in on what looks like an inevitable termination early next month. Or, in what may look like rather a long shot at the moment, it may end up as an acquisition.

It’s an incredibly clever device the ReWalk Exoskeleton, relying as it does in changes in posture and attitude to drive its limbs. You might have seen it being worn by Claire Lomas at the Paralympics. Now you can buy one for personal use.

It’s not often we get to cover a story from Slovenia, so here’s one with the news that SynCardia Systems, Inc.has announced that a Slovenian patient fitted with its temporary Total Artificial Heart, has now received a donor heart after 256 days of life with the device.