Tuesday, August 23, 2016 11:00:50 AM
The Valeo CsC Interbody Device is a spinal implant made of silicon nitride that does not require the use of real bone (autologous, meaning donated from the patient). Rather, the porous center of this revolutionary device is made of silicon nitride as well and it attracts bone growth into and through it.
No longer will back surgeons need to spend time and effort finding and extracting bone from elsewhere on the patient, delicately placing it in position, securing it so that it (hopefully) does not come loose, and worry about adhesion and infections.
The new Amedica device, more resistant to stress than titanium, MUCH stronger than PEEK (plastic), anti-infective, and requiring NO bone, has just been cleared by the FDA for the U.S. market.
Not only will this open up the U.S., but AMDA has inked a multi-year deal with a huge China implant maker/distributor with mandatory minimum purchases. The FDA clearance should make China FDA clearance a breeze.
AMDA has been ramping up sales and distribution for the last couple months in preparation for the clearance of this device.
They are ready to hit the ground running.
Millstone
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