Vascular

Vascular disease specialist Veryan has announced the appointments of Todd M. Pope and Jeffrey B. Jump as Non-Executive Directors. Both have many years’ experience of the medical device industry.

W. L. Gore & Associates, Inc. has received CE mark for the 23 mm and 27 mm diameter sizes of the contralateral leg component of the Gore® Excluder® AAA Endoprosthesis for treatment of abdominal aortic aneurysms(AAA). The company says its new diameter devices provide physicians with the ability to repair AAAs in a wider range of anatomies eligible for minimally invasive endovascular AAA repair.

Teleflex Incorporated has announced its ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter has received FDA 510(k) clearance for central venous pressure monitoring indication.

Flexible Stent Solutions has been granted CE mark for an extended range of its Flexstent peripheral vascular stents. The new line, called Flextent Iliac, does pretty much what it says on the tin, extending the company’s offering to cover more vessels.

A new technique involving retrograde endovascular approach to occluded peripheral arteries shows promise, but hasn’t yet been formally studied. Cook Medical is supporting a multicentre effort to build an evidence base for what could be a promising solution to the major healthcare problems resulting from peripheral artery disease.

The life of a medtech company is never straightforward is it? Just as Medtronic is celebrating victory in a stent graft patent case involving W.L.Gore it also emerges that it is being sued for historical royalty payments of at least $7M, which a University claims it is due because of confusing accounting practices.

University of Pittsburgh’s cell-free, biodegradable artery graft results in a regenerated artery in 90 days, leaving behind no trace of synthetic graft materials in the body.

Maquet is trumpeting its new generation of antibiotic/silver treated vascular grafts which it claims are effective against MRSA. The graft, branded Intergard Synergy, has gained CE mark status and is ready for launch.

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.

Medtronic, Inc. has synchronised the U.S. launch of the recently FDA cleared Endurant® II AAA Stent Graft System with the Society for Vascular Surgery’s Vascular Annual Meeting being held right now. The company claims its new iteration enhances access and ease of use compared with the first generation product.

Hansen Medical, Inc. has announced that it has received FDA 510(k) clearance for its Magellan™ Robotic System, opening the door for transformation of vascular interventions.

Not satisfied with just drug elution as a means of reducing neointimal hyperplasia, OrbusNeich has built in an Endothelial Progenitor Cell capture coating which appears in this blinded study to improve neointimal appearance at 9 months.

Covalon’s IV Clear™ Silicone dressing is comfortable to wear and remove and contains two antimicrobial components within its adhesive layer, making it a compelling proposition in the market for securement of such as IV access devices. Now the product has FDA clearance to add to its Health Canada approval.

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.

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.

Navilyst Medical has announced its entry into the embolisation market with the U.S. launch of its new Embarc® Microcatheter with Glyce™ Hydrophilic Coating, designed for use in small vessels.