Medical device coatings offer physicians greater maneuverability, and may result in less trauma to blood vessels and reduced thrombogenicity (blood clotting within a vessel) for patients. Particulate generation during intravascular procedures remains an area of interest for international regulatory bodies, and the U.S. FDA has as recently as of November 2015 released a Safety Communication stating: 

“The FDA wants to make health care providers aware of the possibility that hydrophilic and/or hydrophobic coatings may separate (e.g., peel, flake, shed, delaminate, slough off) from medical devices and potentially cause serious injuries to patients. Coating separation can be caused by a number of factors including device design or manufacturing processes [1].” The degree to which particulates are harmful to the patient depends on the size, shape, and composition of the particles, as well as where and to what degree they cause an occlusion. [2]

 

Introducing:

Centaur™ Low Particulate, Lubricious Coating by Covalon Technologies Ltd.

Centaur™ low particulate, lubricious coating is designed to improve the safety and functionality of intravascular medical devices such as vascular access catheters, where the presence of unwanted particulate can cause significant patient complications.  In a third party in vitro simulated vascular insertion study designed to measure the levels of particulate, Covalon’s Centaur™ coating resulted in significantly lower levels for all particulate sizes relative to the same catheter without a coating. This contrasts with other industry leading coatings that generate nearly twice as many particles as the same catheter without a coating. Covalon’s Centaur™ coating technology specifically targets and is ideally suited for a growing segment of the medical coatings market focused on minimizing coating degradation without compromising lubricity. 

 

Opportunity
Hydrophilic coatings are expected to show fastest revenue growth at a CAGR of 7.9% from 2016 to 2025 owing to widespread usage in medical devices including cardiac pacemakers. High lubrication and antimicrobial coatings accounted for 40.6% of the overall volume share and are expected to show significant growth in light of their low cost and high compatibility with various device materials. [3]

 

Performance
Covalon’s patented low-particulate, lubricious Centaur™ coating achieves performance standards that are the envy of the industry. Centaur™ sets a new standard for low particulate lubricious coatings for use in procedures where safety and confidence in the coating integrity is essential. 

 

Lubricity of CENTAUR™ PICCs

The coefficient of friction of polyurethane PICCs (5 Fr, 50cm) coated with Centaur™ (n=5) and compared to uncoated controls.

Particulate Generation of CENTAUR™ PICCs

The particulate count of polyurethane PICCs (5 Fr, 50cm ) coated with Centaur™ (n=5) and compared to uncoated controls using a simulated-use model based on ASTM F2743, and adapted to represent the vasculature where a PICC is inserted into the patient’s arm including the appropriate radius of curvature of the path to the patient’s heart (p<0.05).

 

 

References:
1. https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm473794.htm
2. LJ Pesko, “Physiological Consequences of Injected Particulates,” in Liquid- and Surface-Borne Particle Measurement Handbook, ed. JZ Knapp, TA Barber, and A Lieberman (New York: Marcel Dekker, 1996): 661–685.
3. http://www.grandviewresearch.com/industry-analysis/medical-device-coatings-market

 
 

 

CovaCoat™

Our customized medical coatings deliver superior infection control, therapeutic delivery, and increased lubricity. Using our CovaCoat™ technology platform, we collaborate with customers to develop custom and proprietary medical device coatings that offer strategic marketing advantages for their product offerings. CovaCoat™ technology provides a cost-effective and proprietary photochemical process for covalently linking coating molecules to a variety of medical device surfaces for exceptional functionality and performance. Specific coating formulations signal passive or active healing responses to the device.

CovaCoat™ may be customized to provide medical devices specific properties:

  • Lubricious
  • Hemocompatible
  • Antithrombogenic
  • Biocompatible
  • Antimicrobial
  • Controlled drug delivery
  • ID/OD coating

Virtually any medical device or other surface material can be coated with our CovaCoat technology. Each formulation can be engineered to provide controlled delivery of various therapeutics. 

The CovaCoat™ process features sophisticated controls built into the coating process that provides for batch size flexibility or continuous flow production to ensure consistent outcomes. All process applications developed with ISO compliant quality systems are scaled‐up at Covalon prior to technology transfer. Medical companies can choose to apply the coatings in‐house or through a contract manufacturer.

Features and Benefits:

  • Durable: Covalently linked surface coating withstands very high shearing and abrasion forces.
  • Patented: Provides product differentiation.
  • Customizable: For varying geometries, devices and materials.
  • Flexible: Controlled delivery of antimicrobials, antibiotics, peptides and anti‐proliferates.
  • Cost Effective: Costs are spread across numerous applications.
  • Bulk Properties Friendly: Devices perform as intended with improved features.
  • Scalable: All process applications are scaled‐up prior to technology transfer.
  • Commercially Proven: Multiple applications in market with clinical validation.