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Year in Review

Notable Product Launches from 2012

 

The following products represent select devices and technologies launched during 2012 across a span of segments. 
 
ARTHROSCOPY/SOFT TISSUE
 
Covidien: AS Meniscal Repair Device, designed to enable “all-inside” arthroscopic repair of torn knee meniscus via all-suture fixation. One-thumb slide actuation. 
 
COMPUTER-ASSISTED SURGERY
 
Stryker: Stryker ADAPT for use with the Gamma3 Locking Nail to treat hip fracture. System automatically identifies the Gamma3 nail relative to a patient’s anatomy, provides guidance for implant alignment/lag screw length and positioning.
 
FRACTURE FIXATION
 
MedShape: 1st surgical use of DynaNail Ankle Arthrodesis Nail, NiTiNOL-based intramedullary nail. A new NiTiNOL material includes titanium to provide the rigidity of traditional IM nails with axial compressive properties of an external fixation frame. 
 
JOINT REPLACEMENT
 
ConforMIS: iTotal G2 Knee Replacement system, featured anatomic implant design with personalized fit, patient-matched anatomic shape and reportedly greater bone preservation than traditional TKR. Requires only one reusable instrument tray in the OR.
 
SPINE
 
Biomet Spine: Cellentra VCBM (Viable Cell Bone Matrix), comprising viable osteogenic stem cells, verified osteoinductivity and an osteoconductive scaffold. 
 
Medtronic: U.S. launch of ACD enhanced instrument set for insertion of BRYAN Cervical Disc. 
 
Orthopaedic Implant Company: Low-cost pedicle screw system to reportedly save up to $3,000 per fusion level for hospitals and surgical centers. 
 
Osseon Therapeutics: U.S. commercial release of Osseoflex SB steerable balloon, Osseoflex SN+ steerable needle for treatment of vertebral compression fractures. Two cases recently completed in Florida, one in Maryland.
 
Though not commercially launched, we would be remiss not to mention PMA approvals for:
 
Globus Medical: Secure-C cervical disc
NuVasive: PCM cervical disc
Paradigm Spine: coflex Motion Preserving Intralaminar Stabilization device
 
OTHER
 
Esaote: G-scan Brio, Weight-Bearing MRI system optimized for musculoskeletal exams; E-MRI Brio Release 2 platform for acquisition/reconstruction of 2D sequences to speed examination with high image quality.
 
VirtaMed: ArthroS, virtual reality training simulator for knee arthroscopy that allows surgeons to practice procedures before performing them on patients. 
 
 
Sources: Company press releases, web sites, articles in the public domain, FDA 510(k) Releasable Database, filings with the U.S. Securities and Exchange Commission