Approval/Clearance

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.

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.

Another approach to reducing calorific intake is demonstrated with the newly CE marked Satisphere device, an endoscopically inserted series of balloons on a wire, which retain gut contents in the duodenum for longer, creating the feeling of satiation and therefore reducing appetite.

FDA has cleared Theragenics subsidiary Galt’s Valved Tearaway Introducer, opening the door for the company to gain access to a $14m market.

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.

Single study shows novel hydrogel scaffold results in better wounds. Product gets CE mark. Should it really be that simple?

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.

Femtosecond laser technology is fairly new to the ophthalmic surgical profession, especially in the US. Now FDA has cleared Abbott’s device for the creation of curved incisions in corneal surgery including cataract access.

Sotera Wireless Inc is on a mission to improve vital signs monitoring in ambulatory patients. FDA clearance of the company’s ViSi Mobile™ System has just been announced.

St.Jude is making a big deal of the fact that it sought guidance from 200 physicians on the design of its newly CE marked Ellipse ICD device.

Custom Spine’s foray into MIS spinal surgery is kicked off this week with the news that its newly FDA cleared Securis cannulated pedicle screw system is on show at AANS Miami.

Impella cVAD from Abiomed looks like a great tool for the cardiologist faced with the need to provide short term haemodynamic support for cardiac patients, with the advantage that insertion is percutaneous.