ArthroCare Receives FDA Clearance for Spartan 6.5 Needled Suture Implant
Benzinga 15 years ago
NewsFDA
ArthroCare^® Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art,
minimally invasive surgical products, announced today that it has received
clearance from the U.S. Food and Drug Administration (FDA) for its Spartan™
6.5 Needled Anchor (Spartan). The Spartan device is a preloaded threaded
anchor indicated for use in fixation of soft tissue to bone, such as during a
rotator cuff repair. The needled version is utilized for open repairs, whereas
the non-needled version, for which FDA clearance has previously been received,
is for arthroscopic repairs.
The Spartan anchor complements ArthroCare's line of anchors which can be used
with ArthroCare's suture passing technology, such as the FirstPass^® suture
passer. It has a unique 6.5mm, screw-in design and can be used to perform
single and double row repairs. A 5.5 mm version previously received FDA
clearance, as announced on February 15, 2011. The Spartan anchor is
manufactured from PEEK, (polyether-etherketone), a material widely used in
orthopedic implants. More than 400,000 patients undergo rotator cuff surgery
annually in the U.S.
