Hemospray is a proprietary mineral blend powder developed specifically for endoscopic Hemostasis. It contains no human or animal proteins or botanicals and has no known allergens. Hemospray is metabolically inert and deemed nontoxic, systemically or otherwise. Over the years, similar materials have been used by the military for topical battlefield hemostasis applications.
When Hemospray comes in contact with an actively bleeding site, the powder absorbs water, then acts both cohesively and adhesively, forming a mechanical barrier over the bleeding site.
Hemospray, unlike traditional therapies, is a nonthermal, nontraumatic, noncontact modality that doesn’t require the precise targeting of other endoscopic devices. That means:
Summary of Clinical Data:
Clinical data summary information that was, in part, the basis for granting the de novo can be found on the Cook Medical website at CookMedical.com/HemosprayData
Cook does not currently have sufficient data to make claims on the efficacy of Hemospray on anticoagulated patients. Preliminary results have been promising in this patient population, especially in cases where contact and thermal modalities pose additional challenges.
Hemospray does not get absorbed by the body and does not require removal as it passes through the lower GI tract within 72 hours. Early clinical experience indicates that the powder passes through the lower GI tract without occlusion.
To date, we have seen no clinical sign or symptoms of Hemospray being absorbed systemically. Furthermore, similar materials have been orally ingested over the years. Preclinical animal data demonstrated that Hemospray did not cause local or regional particulate or systemic embolic effects.
Hemospray has not yet been evaluated for its effectiveness on nonbleeding sites.
Yes. Various granular hemostats have a long history of use for traumatic external injuries.
Continue applying Hemospray in short 1-2 second bursts until the bleeding site is completely covered with powder and no active bleeding is visualized.
Hemostasis may not be immediate and multiple applications may be required; however no more than three Hemospray devices should be applied per patient.
Similar to current devices, store in a dry location, away from temperature extremes.
Similar materials of this family have been ingested for years with no complications. Hemospray is an inorganic powder and contains no human or animal proteins or botanicals.
Follow normal pre- and postprocedure standards of care.
Depressurize completely by rotating base of handle counterclockwise. Dispose per institutional guidelines for biohazardous medical waste.
Avoid direct contact with bodily fluids. This can be accomplished by flushing accessory channel with air prior to introducing catheter, eliminating mucosal or vessel contact with the catheter tip, not applying suction while catheter is in the endoscope channel, and not submerging the catheter tip in pooled blood. Additionally, when deploying powder, ensure the trigger button is pressed for at least 1-2 seconds. This ensures no residual powder is left in the catheter.
Hemostasis was achieved in arterial bleeds that were created surgically in an anticoagulated porcine model. Additionally, postmarket registry clinical data suggests Hemospray is effective for achieving hemostasis in numerous types of arterial bleeds such as peptic ulcers, postendoscopic mucosal resection or dissection bleeds, Mallory-Weiss tears, upper GI postpolypectomy bleeds, and other hemorrhagic upper GI conditions including GAVE and Dieulafoy lesions.
Additional studies are being conducted to compare Hemospray with the current standard of care.
No. In early animal work, neither localized nor distant (brain, liver or lung) vessel embolization was evident on necropsy and pathology examination.
Hemospray’s primary mechanism of action is to form a mechanical barrier over the bleeding site, which immobilizes the blood. The immobilized blood then clots.
No, the particle size of Hemospray is larger than that of a nanoparticle.
TC-325 was simply the early preclinical descriptor used before the brand name Hemospray was developed.
Hemospray is inert and nontoxic. As a granular material, Hemospray may cause potential irritation to the skin, eyes, and lungs. The Emergency First Aid measures to be considered for unintended exposure to Hemospray powder are as follows:
