What is PuraStat and How Does It Work?
PuraStat is a modern hemostatic agent used to control bleeding during surgical and endoscopic procedures [1.6.9]. It is a synthetic, 100% peptide-based, transparent hydrogel that comes in a pre-filled syringe for ease of use [1.6.4, 1.4.8]. Its mechanism of action is unique; it is a self-assembling peptide solution [1.6.1]. When the acidic PuraStat solution comes into contact with the neutral pH of blood, the peptides rapidly self-assemble into a beta-sheet structure, forming a three-dimensional scaffold that mimics the body's natural extracellular matrix [1.6.7, 1.6.4]. This scaffold creates a physical barrier over the bleeding site, sealing small blood vessels and capillaries to achieve hemostasis, often in seconds [1.6.7, 1.3.6]. A key advantage is its transparency, which allows for continuous visualization of the underlying tissue during application [1.6.6]. After about 30 days, enzymes in the body break down the hydrogel into its constituent amino acids, which are then naturally metabolized or excreted [1.6.4].
Primary Applications
PuraStat is indicated for managing oozing and bleeding from small vessels in various contexts [1.5.9]:
- Gastrointestinal (GI) Bleeding: It is widely used in endoscopy to control bleeding following procedures like endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR), and to treat conditions such as radiation proctitis [1.6.8, 1.3.3].
- Surgical Procedures: It can be applied to the parenchyma of solid organs like the liver, spleen, and pancreas to control surface bleeding [1.5.9].
- Cardiovascular Surgery: Studies have confirmed its safety and performance in complex procedures such as Left Ventricular Assist Device (LVAD) implantation [1.6.4].
Clinically Observed Side Effects and Adverse Events
Across a wide range of clinical studies and post-market surveillance, PuraStat has demonstrated a very high safety profile. The majority of studies explicitly state that no serious adverse events directly related to the PuraStat material itself were reported [1.3.1, 1.3.7, 1.4.1, 1.7.6]. Many sources describe it as safe with no side effects [1.3.6, 1.5.8].
However, it's important to distinguish between adverse events related to the device and those related to the procedure in which it is used. For instance, in one study involving endoscopic sphincterotomy (EST), mild acute pancreatitis was observed in two patients, but these were considered procedure-related complications, not a side effect of PuraStat [1.4.4, 1.7.1]. Similarly, rebleeding can occur after its application, though rates are often lower than with other methods or no treatment [1.4.1]. The overall adverse event rate in one meta-analysis was found to be low, at 4.3% [1.7.4].
Key Safety Characteristics:
- Non-Immunogenic: Being a synthetic peptide made of common amino acids (arginine, alanine, aspartic acid), it is not known to cause an immune or allergic reaction, though the possibility can never be entirely ruled out with any peptide [1.6.3, 1.5.2].
- Does Not Swell: Unlike some other hemostats, PuraStat does not swell upon application or during resorption. This prevents potential compression of underlying nerves or tissues [1.6.4].
- Biocompatible and Absorbable: It is nontoxic and is fully broken down and absorbed by the body within approximately 30 days [1.6.3, 1.6.4].
Contraindications and Warnings
While side effects are minimal, there are specific situations where PuraStat should not be used. These contraindications are crucial for ensuring patient safety.
- Intravascular Injection: PuraStat is strictly not intended for injection into blood vessels [1.5.2].
- Allergies: It should not be used in patients with a known allergy or hypersensitivity to any of its components [1.5.4].
- Severe Coagulation Disorders: Patients with certain inherited or acquired bleeding disorders or very low platelet counts may be excluded from its use in some clinical settings [1.5.1].
- Pregnancy and Children: The product has not been tested in pregnant women or children [1.5.2].
Proper application is also key to its safety and efficacy. For example, some operators have noted a slight delay between pushing the plunger and the gel emerging from the catheter, which requires awareness to ensure precise placement [1.7.6].
Comparison Table: PuraStat vs. Other Hemostatic Agents
| Feature | PuraStat (Peptide Hydrogel) | Hemospray (Mineral Powder) | Gelatin Sponge |
|---|---|---|---|
| Mechanism | Self-assembles into a physical scaffold upon pH change [1.6.3]. | Absorbs water, swells, and adheres to form a mechanical barrier [1.5.3]. | Provides a physical matrix for platelet aggregation and clotting. |
| Composition | 100% synthetic peptides (amino acids) [1.6.4]. | Mineral-based powder, no human/animal components [1.5.3]. | Animal-derived (porcine) gelatin. |
| Visualization | Transparent, allowing view of the bleeding site [1.6.6]. | Opaque powder, can obscure the field of view [1.6.6]. | Opaque. |
| Swelling Risk | Does not swell [1.6.4]. | Swells significantly as part of its action [1.5.3]. | Swells, which can cause compression. |
| Preparation | Ready-to-use in a pre-filled syringe [1.6.4]. | Requires connection to a gas delivery system [1.6.3]. | May need to be cut to size and pre-soaked. |
| Known Issues | May be less effective for massive/spurting bleeds [1.6.3]. | Catheter can block with moisture; not for variceal bleeding [1.6.3]. | Risk of allergic reaction; can potentiate infection. |
Conclusion
The collective evidence from extensive clinical use and multiple studies indicates that PuraStat is an exceptionally safe hemostatic agent with a very low risk of side effects directly attributable to the material [1.5.8, 1.7.5]. Most reported adverse events are related to the underlying medical procedure rather than the product itself [1.4.4]. Its synthetic, non-immunogenic, and fully absorbable nature makes it a valuable tool in both surgical and endoscopic settings for controlling capillary and small vessel bleeding [1.6.2]. The primary risks are associated with incorrect use, such as intravascular injection, rather than inherent properties of the gel. As with any medical device, adherence to the instructions for use and contraindications is paramount for ensuring patient safety and optimal outcomes [1.5.2].
Authoritative Link: For more detailed information, you can review FDA documentation on PuraStat such as K222481. [1.4.1]
