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Medical equipment industry

CardioTech International Receives FDA Clearance for Vision Blood Cardioplegia System

Strategic Insights

— 1 min read

CardioTech International, a global leader in medical devices, has announced that its subsidiary Gish Biomedical has received FDA clearance to market the Vision Blood Cardioplegia (VBC) System with Gish's proprietary GBS (Gish Biocompatible Surface) coating. The VBC System is designed for use in heart-lung bypass surgery and is expected to capture a significant share of the growing market for coated heart-lung products, estimated at $200 million annually. This development is a major milestone for CardioTech International, with the company's products already sold to over 300 hospitals worldwide.

Key Takeaways:

  • The FDA has cleared the Vision Blood Cardioplegia (VBC) System with Gish's proprietary GBS coating for sale in the US market.
  • The GBS coating is a heparin-based, covalently bonded, biocompatible coating that reduces the risk of Systemic Inflammatory Response Syndrome (SIRS).
  • The VBC System offers a unique combination of features, including a proven heat exchange design with over 90% efficiency, an integrated bubble trap, and one-handed installation into the VBC Quick Lock Holder.
  • The VBC is available in various tubing configurations to meet individual patient needs.
  • Heparin-based coatings have been shown to decrease the risk of SIRS by reducing complement activation and platelet adhesion.
  • Heparin-based coatings have been demonstrated to reduce thrombus formation, leucocyte activation, and blood loss, and hemolysis.
  • CardioTech International's products are sold to over 300 hospitals worldwide, and the company is well-positioned to capture a significant share of the growing market for coated heart-lung products.

Statistics:

  • Estimated annual market for coated heart-lung products: $200 million
  • Estimated entire market for heart-lung bypass products: $500 million
  • Number of hospitals selling CardioTech International's products: over 300
  • Maximum rated flow rate of the VBC System: 600 mL/min
  • Heat exchange efficiency of the VBC System: greater than 90% at 250 mL/min

Sources:

  • Pharma Business Week editors, "CardioTech International Receives FDA Clearance for Vision Blood Cardioplegia System", Copyright 2004, Pharma Business Week via NewsRx.com & NewsRx.net.
  • NewsRx.com & NewsRx.net.

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