Regulatory Approval

There’s no stopping Covidien’ s neurovascular clot retrieval device, which the company has announced can now add Brazil to Europe and USA as territories wher eit is approved for sale.

Maxx Medical has announced that its “Freedom Knee” has recently received Chinese SFDA approval and will shortly be available throughout the country. Freedom Knee is a complete, high-flexion primary knee replacement system specifically engineered to address the need for smaller sized and differently proportioned implants that better support Asian lifestyle and physiology.

Achieving device approval in Japan is a major undertaking, so Abbott must be delighted that its Xience Prime everolimus eluting stent has got the nod based on a robust body of clinical evidence.

Capsule Endoscopy marches forward with Given Imaging announcing the expansion of its indications in Japan to cover visualisation and diagnosis of Crohn’s disease.

Vascular Surgeons in Australia now have access to a new technology, with the approval of Cook Medical’s Zilver PTX drug-eluting stent for treatment of peripheral artery disease.

Two new device approvals announced for Canada this week. Neither Medtronic’s DBS therapies for epilepsy nor Boston Scientific’s RF ablation catheter are US FDA approved, but Health Canada are clearly convinced by the weight of the submissions.

How to stent a sidebranch. Cappella knows how and has now supplemented CE mark for its Sideguard® system with Indian approval.

Cook’s Zilver PTX Becomes First SFA Stent and first Drug-Eluting Peripheral Stent