Helistat Absorbable Collagen Hemostatic Agents

• 3 recalls, same reason

  • Terminated Z-1302-2013 FDA Class II ·initiated 28 Mar 2013
  • Terminated Z-1289-2013 FDA Class II ·initiated 28 Mar 2013
  • Terminated Z-1290-2013 FDA Class II ·initiated 28 Mar 2013

  Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

Full name

Helistat/ Helitene Absorbable Collagen Hemostatic Agents

Trade Name

Helistat(Tm) Absorbable Collagen Hemostatic Sponge

Generic Name

Agent, absorbable hemostatic, collagen based

PMA Number

P850010 ↗

FDA Product Code

LMF

Device Class

Class III

Regulation

21 CFR Part 878.4490

Advisory Committee

General, Plastic Surgery

FDA Decision

APPR Approved

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• What types of surgical procedures is Helistat Absorbable Collagen Hemostatic Agent designed for, and why is it particularly useful in those settings?

  Helistat is designed for use in general and plastic surgery settings, where controlling bleeding during soft tissue procedures is critical. Its composition of purified bovine collagen creates a scaffold that promotes platelet aggregation and fibrin formation, accelerating clotting at surgical sites. This makes it particularly useful in procedures where rapid hemostasis is needed to minimize blood loss and improve surgical outcomes.

• Are Helistat sponges reusable, and if not, how is their single-use nature ensured?

  Helistat sponges are explicitly designed for single-use only. Each sponge is individually packaged to maintain sterility, preventing contamination between uses. This packaging ensures compliance with surgical standards and patient safety by eliminating the risk of cross-contamination or degradation from reuse.

• What are the key differences between Helistat and Helitene, and how should a clinician determine which one to use?

  The data provided does not specify differences between Helistat and Helitene, but both are classified as absorbable collagen hemostatic agents. Since they share the same regulatory classification (LMF) and are both absorbable collagen-based, the choice would depend on clinical judgment, specific surgical needs, and the manufacturer’s guidelines. Always refer to the product labeling or consult the manufacturer for precise usage distinctions.

• How should Helistat sponges be stored, and what precautions should be taken to maintain their effectiveness?

  Helistat sponges are supplied sterile and individually packaged to preserve sterility. They should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, as recommended for most sterile surgical supplies. The packaging must remain intact until use to ensure sterility and efficacy. Always follow the manufacturer’s storage instructions to maintain optimal performance.

• What regulatory pathway does Helistat follow, and what does this mean for clinicians or facilities using it?

  Helistat is regulated under the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P850010 and product code LMF. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness, providing clinicians and facilities with confidence in its performance. The PMA classification also indicates that the device is classified as Class III, requiring this higher level of scrutiny before market authorization.