GenVisc 850
GenVisc 850, a 5-injection hyaluronic acid from OrthogenRx, may help relieve OA-related knee pain in patients who are unresponsive to non-pharmacologic therapy and simple analgesics. GenVisc 850 is approved for 5 injections, but some patients may benefit from as few as 3 injections.
OrthogenRx
OrthogenRx
OrthogenRx, Inc. is a medical device company focused on the development and commercialization of treatments for knee pain caused by osteoarthritis (OA). OA is the most common cause of knee pain, causing sufferers significant pain and disability. OrthogenRx’s products GenVisc850 and TriVisc are safe, non-surgical alternatives developed to lubricate the joint and relieve mild to moderate knee pain for patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, eg, acetaminophen. It is our quest to get patients back to the things that matter.
OrthogenRx was acquired in December 2021 by Avanos Medical, Inc., a medical device company focused on delivering clinically superior breakthrough solutions that will help patients get back to the things that matter.
GenVisc 850 is supplied as a sterile, non-pyrogenic solution in 3mL pre-filled syringe.
Proven
· GenVisc 850 is approved in 64 countries with over 45 million syringes distributed worldwide2
· GenVisc 850 has the largest and longest duration double blind clinical study of hyaluronic acids for knee osteoarthritis.3
· GenVisc 850 has been published in over 30 clinical studies.4
Safe5
· Safe as saline placebo
· Free of avian proteins
· Demonstrated safe for repeat injection cycles
Effective
· Provides significant pain relief with results that last6
· Demonstrated improvement in pain relief up to 30 weeks post–first injection cycle7
· Demonstrated improvement of total WOMAC index at 30 weeks: Pain, stiffness and functional capacity8
Unique Reimbursement Code J7320
GenVisc 850 is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics; eg, acetaminophen.
Do not administer to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Do not inject this product in the knees of patients with infections or skin diseases in the area of the injection site.
Do not concomitantly use disinfectants containing quaternary ammonium salts for skin preparation because sodium hyaluronate can precipitate in their presence.
Remove joint effusion, if present, before injecting GenVisc 850. Do not use GenVisc 850 if the package is opened or damaged. Store in the original packaging (protected from light) below 86°F (30°C). DO NOT FREEZE. Do not use after expiration date indicated on package. The shelf life of GenVisc 850 is 36 months. The effectiveness of a single treatment cycle of less than 3 injections has not been established. The effectiveness of repeat treatment cycles of GenVisc 850 has not been established. Strict aseptic administration technique must be followed to avoid infections in the injection site. The safety and effectiveness of the use of GenVisc 850 in joints other than the knee have not been established. The safety and effectiveness of the use of GenVisc 850 concomitantly with other intra-articular injectable products have not been established.
The primary evidence of safety is provided by the comparison of GenVisc 850 to Phosphate Buffered Saline (PBS) in the AMELIA (Navarro, Spain) study.2 In this study, four cycles of 5 injections of GenVisc 850 or PBS were administered with an interval of 6 months for the first three cycles and 1 year for the fourth cycle. Patients were followed for 1 year after the last injection. The population of patients evaluated for the safety of GenVisc 850 included 306 subjects (153 GenVisc 850, 153 PBS). In each treatment group, 127 subjects experienced at least one adverse event during the study and 22 patients (11 in each treatment group) experienced at least one adverse event that was reported as possibly, probably or certainly related to the device. None of the related adverse events were assessed as severe. For the first cycle of 5 injections in the GenVisc 850 treatment group, the 15 adverse events reported as related were pain at the injection site (6), allergic reaction (3), arthralgia (2), bleeding at the injection site (2), bleeding (1) and heaviness (1). In the first cycle of 5 injections for the PBS treatment group, the 14 adverse events reported as related were bleeding at the injection site (6), allergic reaction (3), pain at the injection site (2), arthralgia (2), and arthritis (1).
Do not use GenVisc 850 if the package is opened or damaged. Store in the original packaging (protected from light) below 86°F (30°C). DO NOT FREEZE. Do not use after expiration date indicated on package. The shelf life is 36 months.
