FDA

The US FDA is proposing to establish a system which would require the label of most medical devices and device packages to include a unique device identifier in an endeavour to identify potential problems earlier and better isolate affected populations.

Corin Group must be doing something right for LARS SA to extend its distribution agreement with the company in terms of both time and territories. Most notably the new deal now encompasses USA, subject to Corin handling the 510(k) submission.

Covidien has been on the unpleasant end of FDA’s big stick, the agency having written to the company about a raft of areas in which it has found the handling of the Duet TRS stapler recall to be inadequate.

US Regulatory Agency, the FDA has selected Medtronic’s thoracic stent graft development product for inclusion in its early feasibility pilot program.

Back in February US congressional watchdog, the Government Accountability Office asked FDA to implement more stringent testing of medical devices before market release. Four months on a law firm sees fit to make a meal of it.

FDA has provided useful information on the recently approved Promus Element™ Plus drug eluting stent family of products from Bostons Scientific.

We thought when we saw the approval for Edwards’ Sapien valve to be extended to include a further patient cohort, that it was a great case study into the difference between EU and US regulatory processes, given the five year approval gap between the continents. Seems we were not alone.

It seems members of the FDA Circulatory Devices Advisory Panel have satisfied themselves that the benefits of Edwards’ Sapien heart valve outweighed the risks for as it voted 11-0 in favour of approval of the device for use in high risk patients. The final decision will now rest with FDA itself.

FDA’s executive summary of the state-of-play going into tomorrow’s circulatory devices panel meeting is exhaustive, thorough and actually pretty impressive. Yet again though it raises the question of when enough data is enough, because no doubt Edwards Lifesciences thinks its study already looks under every rock.

Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.

Convincing a surgeon to use a blunt suture needle is akin to asking him to ditch the Aston Martin in favour of the Micra. It’ll work, but not in quite such a satisfying way. Maybe FDA can do a better job than we did twenty years ago when even HIV/AIDS didn’t prove convincing.

FDA’s circulatory devices panel review meeting last week, a routine scheduled event, has been widely reported as ordering some sort of panic stricken review of St.Jude’s Amplatzer® device. The reality was altogether less of a headline grabber.

Consumers union is bent on regulatory tightening and even resorting to print ads in its quest to convince Joe Public that the evil medical device manufacturers are trying to harm him. One wonders whether they have the right objective in mind though because the regulatory regime they might end up with could actually stifle innovation and be more harm to Joe Public than the present set-up.

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.

Whether you’re Synthes, J&J, Boston Scientific or especially Cameron Health, it’s been a pretty good week. Now all we need to do is see a resolution to the endless regulatory debates both sides of the pond and we’ll be happy. Won’t we? Did somebody say 2.3% device tax?

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”?