Implanet wins CE Mark, FDA nod for next-gen Jazz braid

French orthopedic implant company Implanet said today it has won CE Mark approval in the European Union and FDA clearance for its Jazz braid device designed for use with the company’s proprietary Jazz tensioning system.

The company said that the new Jazz braid includes improvements based on surgeon feedback it has received since the initial product’s launch in late 2013. The new version of the device includes an ultrasonically bonded band to improve handling and stability and optimized technical characteristics, Implanet said.

“Innovation is a key driver of Implanet’s development strategy. With this in mind, and in order to continually meet the requirements of the surgical community, we are launching an optimized version of the Jazz braid, the central component of our technological platform in all Implanet products: Jazz band, Jazz lock, Jazz claw, Jazz frame and Jazz standalone,” chief marketing officer Nicolas Marin said in a prepared statement.

“The commercial launch of this new version of the Jazz braid follows the granting of the 10th successive 510(k) clearance by FDA, which strengthens our leadership position in this segment. Always attentive to customer feedback, we are continuing to develop and market new products at a quarterly pace, thus continuing to strictly adhere to our roadmap. This new braid heralds impending upgrades to our technological platform focused on simplifying surgical procedures and facilitating the use of Jazz in new surgical indications,” CEO Ludovic Lastennet said in a press release.

The post Implanet wins CE Mark, FDA nod for next-gen Jazz braid appeared first on MassDevice.

from MassDevice http://ift.tt/2s4FFM9