Regulatory

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.

Lord Howe’s report into the PIP breast implant scandal and specifically MHRA’s handling of it, suggests that the agency acted appropriately given the information available and the regulatory constraints existing at the time. A four year delay between first notification and ultimate action on the face of it looks like a long time, but Lord Howe seems satisfied enough.

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.

MAQUET Cardiovascular LLC has announced that it has received FDA 510(k) clearance for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater haemodynamic support, regardless of their height.

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.

Following CE marking earlier this year, Heart Rhythm 2012 sees Sorin announce FDA approval and US launch of its new pacing, defibrillation and left ventricular leads.

It’s never far from our pages, yet one could be forgiven for thinking that European policymakers are still, well, thinking about how to proceed with revisions to the European Medical Devices Directive and its implementation. That’s not quite true, and here’s how.

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.

Filtration device specialist Nephros, Inc., has announced FDA 510(k) clearance to market its Hemodiafiltration (“HDF”) system for the treatment of chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate.

FDA has cleared Angiodslide’s tiny Proteus™ device for balloon angioplasty and embolic capture in peripheral vessels. It works by folding in on itself on deflation, in so doing drawing the embolic fragments into a sort of inverted balloon-bag. Clever.

Laparoscopic surgery instruments may need to be larger than the access portal through which they are delivered, which means some degree of internal assembly could open up possibilities for more useful devices. Now the way is clear as FDA issues its first such clearance.

You say potato, I say prosthesis. While somehow a therapeutic cranberry capsule has uniquely found its way to market as a medical device, we’re scratching our heads about the whole affair.

More coverage of the barmy Eurocrats’ recommendations for new EU medical device legislation. There’s nothing like a good scandal to get politicians chasing votes, and imposing draconian new rules might create more problems than the one they’re designed to address.

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.

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.