PuraStat vs. Purestat: Clarifying the Product Name
There is a common confusion between the name 'Purestat' and the correct product name, 'PuraStat®'. PuraStat® is a specific medical device manufactured by 3-D Matrix, used by healthcare professionals for controlling bleeding during surgical and endoscopic procedures. It is not a medication for home use. The information provided here refers exclusively to the correct product, PuraStat®.
What is PuraStat and How Does it Work?
PuraStat® is a synthetic hemostatic agent in the form of a clear, viscous peptide hydrogel. Its active component is a formulation of RADA16, a synthetic oligopeptide. Its mechanism of action is based on a unique self-assembly process:
- Synthetic Peptide: PuraStat consists of a repeating amino acid sequence (arginine, alanine, aspartic acid, alanine).
- pH-Triggered Self-Assembly: The acidic peptide solution is contained in a pre-filled syringe. Upon contact with blood and tissue, the change in pH triggers the RADA16 peptides to self-assemble rapidly.
- Extracellular Matrix Mimic: This self-assembly forms a complex, three-dimensional nanofiber network that mimics the body's natural extracellular matrix.
- Mechanical Barrier: The resulting mesh acts as a mechanical barrier, sealing the bleeding site and promoting intrinsic hemostasis within seconds.
- Absorbable and Biocompatible: The hydrogel is non-toxic and is resorbed by the body over approximately 30 days, breaking down into constituent amino acids.
Proper Application: How to Use PuraStat?
Disclaimer: PuraStat® is a medical device and should only be applied by a trained healthcare professional in a clinical setting. Always refer to the official Instructions For Use (IFU) provided by the manufacturer.
PuraStat® comes ready-to-use in a pre-filled syringe, eliminating the need for preparation or mixing. The application process generally follows these steps, typically using an endoscopic applicator:
- Prepare the Bleeding Site: Use suction to remove as much blood as possible from the hemorrhagic site to ensure clear visibility and maximum contact with the tissue.
- Attach Applicator: Connect the endoscopic applicator to the PuraStat® syringe using the Luer-Lock connector, ensuring a tight fit.
- Prime the Catheter: Before insertion, slowly prime the catheter to expel any air and ensure a continuous flow of the gel.
- Position the Applicator: Advance the applicator through the endoscope's working channel. Position the nozzle as close as possible to the bleeding point.
- Apply PuraStat: Dispense an adequate quantity of the hydrogel, moving the applicator to cover the entire lesion. Work from the distal (furthest) part of the lesion toward the proximal (closest) area.
- Do Not Disturb: Allow the hydrogel to self-assemble undisturbed. Do not touch or irrigate the area, as this can disrupt the clot formation. Hemostasis is typically achieved very quickly.
- Repeat if Necessary: If hemostasis is not fully achieved, additional applications can be made. Apply the new material directly through the previously applied gel, as close to the bleeding point as possible.
- Confirm Hemostasis: Once bleeding is confirmed to have stopped, any excess PuraStat® may be left in place, as it will be absorbed by the body.
Indications, Contraindications, and Safety Profile
PuraStat® is indicated for use in a variety of procedures and patient situations, and its use is subject to specific contraindications to ensure patient safety.
Common Indications
- Hemostasis of mild and moderate GI bleeding.
- Bleeding after endoscopic submucosal resection (ESD) or endoscopic mucosal resection (EMR).
- Intraprocedural venous bleeding.
- Management of rectal mucositis (RM), such as radiation proctitis.
- Adjunct, bridge, prophylactic, or rescue therapy for GI bleeding.
Key Contraindications
- Hypersensitivity: Patients with a known allergy or sensitivity to any component of PuraStat® should not be treated.
- Bleeding Disorders: It is contraindicated in patients with inherited or acquired bleeding disorders.
- Fibrosis: Severe fibrosis can be a contraindication.
- Advanced Conditions: Certain advanced or inflammatory conditions, such as inflammatory bowel disease, may exclude patients.
- Massive Bleeding: The device is less effective in massive arterial bleeding and should not be used as a sole therapy for large, high-pressure bleeds.
Safety Information
Clinical studies and case reports have generally shown PuraStat® to be safe, with no reported adverse events related to the product itself. Its synthetic nature removes the risk of transmitting infectious diseases, which can be a concern with animal-derived hemostatic agents.
PuraStat® vs. Other Endoscopic Hemostatic Agents
Comparing PuraStat® to other hemostatic agents can help clinicians determine the most appropriate tool for a given clinical situation. Below is a comparison table outlining key differences between PuraStat® and Hemospray®, another endoscopic hemostatic agent.
| Feature | PuraStat® (Synthetic Peptide Hydrogel) | Hemospray® (Mineral-based Powder) |
|---|---|---|
| Active Component | Synthetic RADA16 peptide formulation | Mineral-based powder |
| Mechanism | Self-assembles into a nanofiber scaffold upon contact with blood and pH change | Absorbs water, swells, and adheres to the bleeding site, forming a mechanical barrier |
| Application Method | Applied as a liquid hydrogel via a catheter through an endoscope | Delivered as a powder via a spray mechanism |
| Visibility | Transparent, allowing for clear visualization of the underlying tissue | Opaque, can obscure visualization of the bleeding site and surrounding tissue |
| Limitations | Less effective for massive, high-pressure bleeding | Risk of catheter blockage from ambient moisture; not suitable for variceal bleeding |
| Degradation | Biodegradable; resorbed by enzymatic action | Absorbed by the body and washes out over 12–24 hours |
The Benefits of Using PuraStat®
Using PuraStat® offers several advantages in clinical practice:
- Ease of Use: Delivered in a pre-filled syringe, it requires no preparation time.
- Rapid Hemostasis: Its self-assembly process allows for quick control of mild to moderate bleeding.
- Clear Visualization: The transparent nature of the gel maintains visibility, which is a significant advantage during delicate endoscopic procedures.
- Effective Sealing: The self-assembling fibrous network effectively seals the bleeding point and can even be clipped or sutured through if needed.
- Bioabsorbable: It is absorbed by the body, eliminating the need for removal and promoting the healing process.
- Broad Applicability: Effective as both a primary or secondary hemostatic agent across various GI bleeding scenarios.
Conclusion
PuraStat® represents an important tool in the clinician's arsenal for managing and preventing bleeding in gastrointestinal procedures and other surgical settings. By understanding its unique self-assembling peptide hydrogel technology and adhering to the correct application protocol, healthcare professionals can achieve rapid and effective hemostasis, improving procedural outcomes and patient safety. Its ease of use, safety profile, and transparency make it a valuable option for controlling mild to moderate bleeding and serving as a reliable bridge to further treatment if needed. Given its synthetic nature, it also mitigates the risks associated with biologically derived hemostatic agents. For further clinical data and information, refer to peer-reviewed studies published on platforms like the National Institutes of Health (NIH) website.
