FDA Says Edwards Can Start Trial Of CE Marked Valve Technology

Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.

U.S. Launch For Medtronic’s Endurant® II AAA Stent Graft System

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.

Office Intrauterine Polyp Removal A Reality With US Launch Of Smith & Nephew’s Truclear™ 5.0 Hysteroscopic Morcellator

Smith & Nephew has announced the launch of its Truclear 5.0 System, according to the company the smallest hysteroscopic morcellator system to receive FDA 510(k) clearance. The company claims its system’s smaller size now provides surgeons with the potential of using it in the office setting.

Covidien’s Bigger Ablation Catheter Increases Treatment Area In Barrett’s Oesophagus

Covidien has unveiled its new range add HALO 90 ULTRA for ablative treatment of large Barrett’s Oesophagus lesions. The device, which comes from the stable of recently acquired Barrx Medical, is double the length of its HALO 90 brother and as such can reduce ablation treatment time and in so doing shorten the procedure.

Centrally Funded Collaborative R&D Could Spell Future

So the EU (European Commission) funds a collaborative project to develop a technology that addresses a very real (and rather high profile) clinical need. Collaborating companies benefit and so thrive and employ more people, in so doing addressing the need to do just that. This new continental collaborative concept might just work and if it does everyone’s a winner.

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