EndoClot, specifically the Polysaccharide Hemostatic System (PHS), is a medical device designed for the endoscopic control of nonvariceal gastrointestinal (GI) bleeding. At its core, the system relies on a hemostatic powder with a unique and biocompatible composition. Its active component, the hemostatic powder, is made of Absorbable Modified Polymer (AMP®) particles, derived entirely from plant starch. These particles contain no human or animal components, making them a safe and effective solution for a variety of endoscopic procedures.
The Core Composition: Absorbable Modified Polymer (AMP®)
The active ingredient in the EndoClot PHS powder is AMP®, a proprietary material that undergoes a specialized engineering process. Key characteristics of AMP® particles include:
- Plant-Based: AMP® is derived from plant starch, meaning it is non-synthetic and free of animal or human-derived components.
- Hydrophilic: The particles are highly hydrophilic, giving them the ability to rapidly absorb water from blood and other bodily fluids.
- Biocompatible and Non-Pyrogenic: Comprehensive testing has confirmed that AMP® is biocompatible and non-pyrogenic, meaning it does not cause an inflammatory reaction or fever.
- Biodegradable: Once applied, the AMP® particles are naturally degraded by digestive enzymes, primarily amylase and glucoamylase, within a few hours.
How the Starch-Derived Powder Stops Bleeding
The mechanism of action for EndoClot's AMP® powder is a simple but highly effective process rooted in its unique composition. When the powder is sprayed onto a bleeding site in the GI tract, the AMP® particles immediately begin absorbing water from the blood. This rapid dehydration causes a hyperconcentration of key clotting elements at the wound site, including:
- Platelets
- Red blood cells
- Coagulation proteins (e.g., fibrinogen)
This high concentration effectively accelerates the body's own natural clotting cascade. As the particles interact with the blood, they form a robust, gelled, adhesive matrix that acts as a physical, mechanical barrier over the wound. This barrier seals the bleeding vessel and protects the tissue underneath, providing immediate and effective hemostasis.
Comparison of EndoClot Products
While the AMP® powder is the most well-known formulation, the EndoClot system includes other products designed for specific endoscopic applications. The core component of these products may differ slightly in its modification to optimize for its intended use.
| Feature | EndoClot® PHS (Polysaccharide Hemostatic System) | EndoClot® SIS (Submucosal Injection Solution) | EndoClot® Adhesive |
|---|---|---|---|
| Composition | Absorbable Modified Polymer (AMP®) powder | Absorbable Modified Polymer (AMP®) particles mixed with saline | Adhesive Hemostatic Polymer (AHP) powder |
| Intended Use | Hemostasis of nonvariceal GI bleeding | Submucosal lift for procedures like EMR and ESD | Sealing wounds and assisting clot formation |
| Mechanism | Rapidly absorbs water to concentrate clotting factors and form a mechanical barrier | Creates a long-lasting, high mucosal lift for excision | Forms a more durable, gelled, and adhesive matrix |
| Absorption/Degradation | Degraded by digestive enzymes like amylase within hours | The AMP® component is absorbed over time | Not degraded by human enzymes; eliminated with stool |
The Delivery System and Application
EndoClot’s efficacy is dependent not only on its composition but also on its delivery system, which allows precise application through an endoscope. The system consists of:
- An air compressor that provides consistent pressure
- An air-powder mixing chamber
- A flexible catheter that is inserted through the endoscope's working channel
The compressor propels the powder through the catheter and onto the bleeding lesion. A key design feature is the anti-reflux mechanism, which prevents the hydrophilic powder from prematurely mixing with fluids inside the catheter and causing an occlusion. Consistent air pressure from the compressor also helps to avoid the "white-out" effect, where visual clarity is compromised during application.
Safety and Biocompatibility
The plant-derived and biocompatible nature of the AMP® particles underpins the safety profile of EndoClot. Clinical studies have shown the product to be both safe and effective in controlling bleeding in nonvariceal upper GI bleeding cases. However, as with any endoscopic procedure, the use of EndoClot PHS carries some risks. Adverse events, while rare, can include inflammatory reactions, bowel rupture, and air embolism. A significant precaution is for patients with a known starch allergy, for whom the product should not be used. For most patients, particularly those with coagulation impairments or on anticoagulants, EndoClot can still effectively achieve hemostasis.
Conclusion
EndoClot's composition is a testament to the power of biomaterial engineering. At its core, the hemostatic agent is an Absorbable Modified Polymer (AMP®) derived from plant starch. This biocompatible, hydrophilic powder rapidly absorbs water from blood to initiate a powerful and localized clotting cascade, forming a gelled matrix to seal the wound. The system’s innovative delivery method allows for precise and effective treatment during endoscopic procedures. While various formulations exist for different clinical applications, the fundamental principle of using a plant-based material to achieve fast, safe, and effective hemostasis remains consistent. Understanding the answer to "what is EndoClot made of?" highlights its safe, natural origin and intelligent design.
