One-year results from a study of Smith & Nephew's NOVOSTITCH Meniscal Repair demonstrated a success rate of 91.7% and significant improvement in knee pain and function in all patient reported outcomes.
Results from a feasability study indicate that use of the Bridge-Enhanced® ACL Repair (BEAR®) procedure from Miach Orthopaedics resulted in similar clinical, functional and patient-reported outcomes as autograft ACL reconstruction at 24 months.
Results from cadaveric study of OrthoSpace's InSpace balloon spacer vs. superior capsular reconstruction in the treatment of rotator cuff tears found that InSpace effectively restored the humeral head to a nearly normal position.
MIACH Orthopaedics completed US $22.5MM in financing to support manufacturing and continue clinical trials for the Bridge-Enhanced® ACL Repair (BEAR®) implant, designed to stimulate healing of torn anterior cruciate ligaments.
MinInvasive, developer of the OmniCuff™ for rotator cuff repair, entered into a strategic partnership and financing round with MicroPort Scientific, which will exclusively distribute OmniCuff in China.
Biomedical Structures, manufacturer of biomedical textile implants with application in orthopaedics, was acquired by Confluent Medical Technologies, a contract manufacturer of Nitinol components and kyphoplasty balloons. Terms were not disclosed.
Strategic orthopaedic-related 510(k)s issued in May 2016 include: Navio Indication for TKA (Blue Belt Technologies), Enza Zero-profile Anterior Interbody Fusion System (Camber Spine), CSR Shoulder System (Catalyst OrthoScience*), Stropp/Single Tunnel Repair of Plantar Plate (CrossRoads Extremity), Cervical Interbody Fusion System (Evolution Spine*), Flip Button Suture Anchor (First Ray), Neofuse HA Enhanced PLIF/TLIF (HT Medical*), HC Spinal System (Hung Chun Bio-S*)
The arthroscopy/soft tissue segment reached sales of $4.5 billion in 2015, a four percent increase over 2014, according to ORTHOWORLD estimates. Growth in the market is buoyed by several factors: strength of the main players, smaller players expanding their portfolios to complement other product lines, industry focus and surgeon adoption of minimally invasive techniques and surgeons' push to drive new technologies and techniques in ligament and tendon care and repair.
On 4/20/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Cartiva's Synthetic Cartilage Implant, an organic polymer-based biomaterial designed to mimic biologic cartilage.