23
DEVICES
&
INNOVATION
ISASS Releases New
Coverage Rule for
Decompression With
Interlaminar Stabilization
By Laura Dyrda
T
he International Society for the Advancement of
Spine Surgery released new coverage criteria for
decompression with interlaminar stabilization.
The coverage recommendation policy examines de-
compression with interlaminar stabilization
for lumbar
spinal stenosis patients. The society doesn't recom-
mend any one particular treatment but does recognize
decompression with interlaminar stabilization as an op-
tion for treatment based on the patient's pathology, sur-
geon's expertise and shared decision-making process.
Among select patients, the rule notes decompres-
sion alone isn't adequate and those patients could
benefit from interlaminar stabilization after direct de-
compression. Paradigm Spine's coflex has achieved
FDA pre-market approval for patients who have up to
Grade I spondylolisthesis.
There have been two prospective, randomized,
multi-center, controlled, Level 1 clinical studies exam-
ining decompression with interlaminar stabilization.
The studies provide "strong evidence" in support of
interlaminar stabilization after decompression for qual-
ity of life and durability in the appropriate patients.
The new codes effective Jan. 1, 2017 include:
• CPT 22867 for "insertion of interlaminar/interspinous
process stabilization/distraction device, without fu-
sion, including image guidance when performed, with
open decompression, lumbar; single level"
• CPT 22868 for "insertion of interlaminar/interspinous
process stabilization/distraction device without fusion,
including image guidance when performed with open
decompression, lumbar; second level (List separately
in addition to code for primary procedure)" n
Zimmer Biomet, Stryker, Wright
Medical Group & More: 12 Key Notes
By Anuja Vaidya
Wright Medical Technology, a wholly-owned subsidiary of
Memphis, Tenn.-based Wright Medical Group, entered into a
metal-on-metal hip litigation settlement agreement.
Surgeons have utilized Warsaw, Ind.-based Zimmer Biom-
et's Vitality Spinal Fixation System in 1,500 surgeries.
Warsaw, Ind.-based Zimmer Biomet released two-year trial
results of its Aspen MIS Fusion System as an adjunct to anterior
and lateral interbody fusion. The Aspen system's interbody
fusion success rate was 94.9 percent.
Amid a year of acquisitions, Warsaw, Ind.-based Zimmer Biom-
et lowered the high end of its forecasted profits and cut its
sales guidance, wreaking havoc on the company's share price
on Oct. 31, 2016.
Kalamazoo, Mich.-based Stryker's spine division re-
vealed results from a pre-clinical study for its 3D-printed Tritani-
um PL Interbody Cages. The study found the Tritanium PL cages
demonstrated reductions in segmental motion.
Denver-based TranS1 recently launched the Capital Bone
Graft Harvester and Pylon Graft Delivery systems.
Cologne, Germany-based Dreifaltigkeits-Krankenhaus Clinic sur-
geons utilized OrtoWay's OrtoWell device during a lateral, mini-
mally invasive surgical fixation procedure as part of a corpectomy.
The FDA cleared Parsippany, N.J.-based Onkos Surgical to
market its ELEOS Limb Salvage System.
The FDA cleared magnetic resonance imaging for certain
conditions on patients treated with San Diego-based NuVa-
sive's MAGEC system.
Carlsbad, Calif.-based SeaSpine earned FDA clearance for its
Shoreline Anterior Cervical Standalone System.
Mark McFarland, DO, completed his 100th P-LIFT less exposure
surgery using Beverly, Mass.-based SpineFrontier's LES-PLIFT
interbody cage at Mary Immaculate Hospital in Newport News, Va.
Atlanta-based Medovex successfully completed a live tissue
test of its DenerveX System, adhering to FDA standards. n
7 New Spine, Orthopedic Device Launches & Releases
By Anuja Vaidya
Here are seven devices that were recently
launched or released.
Caesarea, Israel-based Mazor Robotics launch-
ed Mazor X commercially in October 2016.
Leesburg, Va.-based K2M introduced
its CASCADIA Interbody Systems to the
U.S. market.
Dallas-based Pinnacle Spine Group launched
its InFill V2 Lateral Interbody Device.
West Chester, Pa.-based DePuy Synthes intro-
duced its new visualization system, the KICK
System with FluoroExpress Soware Module.
DePuy Synthes' spine division recently
launched its ZERO-P NATURAL plate that
supports bone growth and stability during
spinal fusion procedures in the neck.
Warsaw, Ind.-based Zimmer Biomet intro-
duced its Comprehensive Vault Reconstruc-
tion System.
Logan, Utah-based Kator is launching its Su-
ture Anchor System on a limited basis. n
