Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea Vastus Medialis without Trochleoplasty in Small Breed Dogs: A Retrospective Review of 22 Cases

다국어 초록 (Multilingual Abstract)

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicineby the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into classI-IV according to risks of individual and public health. However, good manufacturing practices requirements onIVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant QuarantineAgency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infectiondisease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug ofabuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association wasestimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales wereapproximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumptionand 40.4% (CAGR) in export from 2011 to 2017.
muscle, patellar anti-rotational suture, fascia lata overlap, and tibial tuberosity transposition (TTT) were undertakento stabilize the patella without trochleoplasty. Data including signalment, clinical symptoms, details of the affectedhindlimb, preoperative and postoperative patellar luxation grades, postoperative recovery time, and postoperativecomplications were obtained from medical records. The grade of lameness was evaluated preoperatively andpostoperatively. Mean (± SEM) grade of medial patellar luxation was 2.64 ± 0.11 preoperatively and 0.2 ± 0.27postoperatively. Mean (± SEM) grade of lameness was 1.73 ± 0.27 preoperatively and 0.18 ± 0.15 postoperatively.
Patellar reluxation occurred in 1 of 22 (4.5%) cases requiring additional surgery. At final follow-up, 2 of the 22 (9.0%)dogs, including one with reluxation, had occasional lameness. Client-based questionnaire results demonstrated significantimprovements in all parameters. Surgical treatment of MPL that included resection of the vastus medialis oblique withoutfemoral trochlear groove deepening improved surgical outcomes in dogs with up to grade 3 MPL.

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