Regulatory

KFx Medical Corporation has announced it has received FDA 510(k) clearance for its 5mm AppianFx® Tissue Fixation Anchor, opening the door to the growing foot and ankle tendon fixation market.

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.

BAAPS has issued a statement broadly supporting the conclusions of the Chief Medical Officer’s report into the PIP breast implant situation. The association is urging women to take up the offer of consultation and potential explantation, and urging the private sector providers to do exercise their own duty of care.

St. Jude Medical, Inc. has received FDA clearance and will immediately launch the Amplatzer™ Vascular Plug 4 for use in transcatheter embolisation procedures within the peripheral vasculature.

Kinetic Concepts, Inc. announced today that it has received FDA 510(k) clearance to market its proprietary Vacuum Assisted Closure®, or V.A.C.® Therapy System, for the management of closed surgical incisions.

Sir Bruce Keogh, Medical Director of the UK’s NHS, has released his report on the PIP scandal, which reassuringly suggests the content of the implants, while being suitable for mattresses, is also non-toxic to humans. His advice to patients remains the same; If they’re troublesome, take them out.

We seem to be writing about Renal Denervation every few weeks as the players unveil their latest approval of latest study result. So we thought it worth stepping back and considering the state of play for a moment.

News, views, opinions, events from another week keeping a close eye on medical device technology.

Cardiosolutions Inc., has announced that it has received FDA 510(k) clearance to market its Dexterity Steerable Introducer, a next generation structural heart access introducer and delivery conduit.

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.

TransCorp Spine has received FDA 510(k) clearance for its SpinePort™ Spinal Access System which provides direct access and visualisation to aid surgeons in treating cervical spine pathologies through a transcorporeal microdecompression procedure.

There’s no doubt that much of what is proposed in the European Parliamentary measures to improve patient safety represent sensible and overdue measures. But the European “PMA” is sounding like a hammer to crack a nut. Eucomed isn’t sounding convinced either.

J&J’s Cordis division is worried that one lot of its Fire Star Rx Balloon Catheters runs the risk of deflating too slowly or worse, not at all. The recall is limited to certain Far Eastern countries.

Parliamentary select committee on medical device regulation saw witnesses from industry and regulatory stakeholders today. It’s all looking very harmonious, but has anyone thought about the cost of the brave new world that is being sold to us?

Treatment of Refractory Epilepsy by Vagus Nerve Stimulation is to be made available in Europe as Neurotech’s unique rechargeable device gains CE mark approval.

Round 2 for the Parliamentarians to sit and grimace about medical matters and especially device regulation. Can’t wait.