On June 19, Ethicon, a subsidiary of Johnson & Johnson Medical Devices Companies, announced 510(k) clearances for its Vistaseal dual applicator, a tissue sealant product for use in open and laparoscopic surgery, and the first clearance since the company partnered with Spain-based Grifols, a leading provider of plasma-derived medicines worldwide.
Prompt hemostasis and effective incision closure have been major concerns for surgeons. As medical technology advances, the surgeon’s toolbox expands to include more effective products, such as biosurgery sealants that actively stop bleeding in cases where the application of pressure, ligature, and other conventional methods are ineffective.
Tissue sealants are associated with higher success rates, ease of operation, shorter recovery times, and higher patient satisfaction. Vistaseal is Ethicon’s next-generation airless spray device that combines biologics with device technology.
Although high costs, weak reimbursement, and stringent regulatory guidelines in some markets prevent wider adoption of products, the biosurgery market is expected to steadily flourish to address an expanding array of clinical applications and surgical specialities.
According to GlobalData, the global sealants market, valued at $1.5 billion in 2018, is expanding at a compound annual growth rate (CAGR) of 4.7% to reach $2.1 billion in 2025. The increasing number of surgical procedures, especially laparoscopic procedures, is the major factor driving growth in the biosurgery market. The market is also expected to grow due to increasing acceptance of these products as alternatives to traditional closure techniques, as they have better outcomes and deliver better patient acceptability.
Ethicon holds the largest share in the global tissue sealants market, followed by Baxter. Both companies have established presences in the global market, with a focus on R&D activities.
Ethicon’s leading position has been further strengthened due to the strategic partnership with Grifols. After the global launch of Vistaseal in the second half of 2019, it can be expected the share of Baxter would be likely to decrease if there is no update for its leading brand, Tisseel.