Editor's Note: “Keep me informed on what everyone is doing” is, without fail, one request returned in every ORTHOWORLD Membership Survey. In seeking to do just that, let’s get a jump on one yearly recap: product launches. (Spine will be addressed in the next installment of THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT®.)
Five years ago, would joint recon folks anticipate that hospital solutions would account for nearly as many launches as devices would, in one year? A shifted focus to delivery of care seems to be the way to tweak hip and knee lines, now.
In reviewing 2016 joint recon segment launches, three themes stood out: the aforementioned care delivery, surgical assistance tools and continued momentum in extremities.
Focus: Healthcare Delivery Support
All of the top five companies debuted initiatives to help providers address myriad components of an episode of care.
DePuy Synthes introduced an exclusive strategic alliance with Value Stream Partners to facilitate customers’ implementation of bundled payment programs for hips and knees. (This builds on DePuy’s U.S. ADVANTAGE Outpatient Solutions Program, offering implants and an outpatient-centric suite of education, training and support services.)
Medtronic Orthopedic Solutions has launched to support total joint replacement episodes of care, addressing the CMS Comprehensive Care for Joint Replacement bundled payment initiative. The model includes launch of the value-based total knee arthroplasty system acquired with Medtronic’s purchase of Responsive Orthopedics.
Aspects of the model include coordination of patient management and care teams across pre-op, acute and post-acute settings to reduce costs and improve efficiencies; remote patient monitoring tools; the FDA-cleared, U.S.-manufactured total knee implant plus the use of the Aquamantys system for bleeding control.
Medtronic Orthopedic Solutions' revenue will be reported as part of Medtronic’s spine sales.
Smith & Nephew (SNN) introduced its eCap/Episode of Care Assurance Program, an initiative designed to mitigate risk associated with readmissions. eCAP pairs all SNN primary total hip and knee reconstructive systems with PICO negative pressure wound therapy and ACTICOAT antimicrobial barrier dressing. If a patient is readmitted within 90 days post-op for a surgical site infection or for implant revision due to product failure, SNN will pay a hospital’s unreimbursed costs for the readmission up to the purchase prices of the implant, PICO and ACTICOAT.
Stryker Performance Solutions offered two initiatives: JointCOACH, a digital patient engagement and education platform, and Episode Performance Manager, a digital tool to translate raw claims data provided by Medicare into dynamic reports to compare performance of hospitals participating in CJR.
In the U.S., Zimmer Biomet beta-launched Signature Solutions, a suite of clinical services and technologies to assist hospitals and medical practices with the transition to value-based healthcare models. Broad release is slated for 2017.
Focus: Surgical Assistance in Hip and KneE
These tools support surgeons throughout procedure planning and execution. In essence, they are also supporting healthcare delivery as they are intended to make procedures reproducible and more precise.
Brainlab introduced Auto-Knee, a new feature of TraumaCad 2.5 that supports pre-op planning of knee arthroplasty by automatically registering anatomical landmarks.
Exactech announced the successful first U.S. revision knee procedure using the ExactechGPS Guided Personalized Surgery system.
OrthAlign launched the OrthAlign Plus navigation device for total hip arthroplasty, for use with the direct anterior approach.
OrthoGrid introduced new HipGrid Drone accessories to address C-arm distortion and magnification issues during surgical planning for total hip arthroplasty.
Smith & Nephew announced the first surgical case of its NAVIO robotics-assisted surgical system in a total knee replacement procedure, using the JOURNEY II BCS knee.
Focus: Shoulder and Ankle
Exactech and Integra both introduced products for the high-growth extremities recon subsegment, during 2016. Exactech announced the first surgery using the Vantage Total Ankle; full U.S. market launch is slated for 2017. Integra completed initial procedures with the Cadence Total Ankle in Europe and the U.S. (The device is also available in Canada under special access conditions.)
In shoulders, Integra launched the Fin-Lock Glenoid for the Titan Modular Shoulder System to address glenoid component loosening and failure, while Exactech added a revision shoulder to its extremities lineup and announced first shoulder procedures with ExactechGPS.
Other device introductions supporting Joint Reconstruction in 2016 included:
ConforMIS: full commercial launch of iTotal PS customized posterior stabilized total knee
Maxx Orthopedics: PCK revision knee, comprising Freedom Stemmed Tibial components with PCK femoral components and constrained liners
Smith & Nephew: REDAPT Revision Acetabular Fully Porous Cup with CONCELOC technology, its 1st 3D-printed titanium hip implant
Zimmer Biomet: the Arcos One-Piece Revision Hip system; Echo Bi-Metric Microplasty Stem; G7 Dual Mobility Construct; enhancements to OSS Orthopedic Salvage joint reconstruction prostheses; OsseoTi Tibial Sleeves; Persona Medial Congruent Bearings and the Vanguard Individualized Design total knee construct, offering two individual polyethylene bearings with different articulations to support a patient-specific fit
Introductions in this segment hailed from start-ups to well-established companies. Though numerous offerings had application throughout the body, we call out one specific area of higher volume of launches than other trauma products within 2016.
Acumed launched the Ankle Plating System 3, spanning the lateral, medial and posterior malleoli and used in combination with the Acumed Small Fragment Base Set.
Agent Medical launched ArthroBridge, an implant for the treatment of hammertoes, and the ArthroMate rasp designed for use in rear foot fusion.
Arthrosurface launched CheckMATE 3.0, a fusion plate for end-stage toe arthritis.
Centric Medical’s launches included a Hammertoe Correction System Subtalar Arthroereisis Implant (limited launch, with full release coming in 1Q17) and TARSA-LINK, a PEEK-based standalone wedge for internal fixation of fractures, fusions and osteotomies in the foot/ankle.
Extremity Medical announced launch of the AlignX Ankle Fusion system and completed over 20 procedures. The company also commenced U.S. launch of IO FIX 2.0 implants and instruments for midfoot fusion.
Flower Orthopedics launched an MTP Fusion Plate component for the First Ray IndicationCube and also commenced full market launch of Flower E-Kit, containing all required cannulated and plating instruments for midfoot, forefoot and ankle in one single-use package.
Prior to its acquisition by Stryker, Instratek launched the HammerFIT Extremity Reamer in the U.S.
Medline launched UNITE Foot Plating and ARROW-LOK Digital Fusion systems.
Focus: A First and an Only
Cartiva’s Synthetic Cartilage Implant—the first synthetic cartilage device to gain FDA approval—was implanted in the first commercial U.S. patient following its FDA Premarket Approval for the treatment of great toe arthritis.
Stryker announced U.S. availability of SonicAnchor, reportedly the only implant in the U.S. that employs ultrasonic energy to liquefy and flow into cancellous bone, for suture or tissue fixation. Though released by the company’s Foot & Ankle unit, the anchor has application in foot, ankle, knee, hand, wrist, elbow and shoulder open procedures.
Viscosupplement product launches appeared six times in ORTHOFLASH during 2016, as opposed to once in 2015. This year brought a new name to the scene, too: AmnioVisc.
Anika Therapeutics commenced Canada and EU launches of CINGAL viscosupplement to treat
knee osteoarthritis pain
Bioventus launched DUROLANE single-injection hyaluronic acid-based OA treatment in Taiwan for the treatment of mild to moderate knee OA. Further, the company commenced U.S. launch of GELSYN-3, a three-injection hyaluronic acid product to treat knee OA pain.
Fidia commenced U.S. launch of Hymovis 2-injection highly-viscoelastic hyaluronan, also for the knee OA pain indication.
Lattice Biologics launched AmnioVisc, a minimally-processed amniotic fluid supplement for the treatment of osteoarthritis pain in all joints. (The product was previously named AmnioClear LCT from Liventa Bioscience.) Results from a 275-patient study demonstrated lasting pain relief and fewer adverse events than hyaluronic acid viscosupplements, the current standard of care, including single-injection MONOVISC, 3-injection ORTHOVISC and Synvisc-One.
Sources: Company press releases, websites;images courtesy of manufacturers