Terms of Use
Statement of Indications for Use:
The HemWell MD (formally Ultroid) Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I,II, III , IV.
Low energy direct current is applied directly to the hemorrhoid, producing sustained vasoconstriction of the smooth muscle media of the arteries supplying the hemorrhoid mechanically occluding its blood supply. Mechanically ligating the hemorrhoid.
Coagulative hemostasis permanently causes cessation of blood flow via coagulation of its blood supply. The detailed mode of action for this hemostatic process is described in another section of the website but in summary results from vasospasm and thrombosis of the hemorrhoid’s blood vessels causing immediate shrinkage or the hemorrhoid.
COAGULATIVE HEMOSTASIS IS NOT COAGULATION.
Coagulation is primarily the thermal destruction of all tissue, also secondary producing hemostasis via sealing of the blood vessel it contacts shut. Electric cautery like HET is an example of a device using electric current to product coagulation via heat production. All tissue in contact with this thermal energy are destroyed.
HemWell’s Coagulative Hemostatic process primarily causes Vasospasm mechanically occluding blood vessels followed by thrombosis without heat production, permanently cutting off blood flow to the hemorrhoid, i.e. by definition, ligating blood flow. HemWell does so without coagulating other hemorrhoid components, i.e. little effect on the cushion, veins, connective tissue and mucosal covering.
The current produced by HemWell spreads deep into the hemorrhoidal blood supply, ligating vessels remote from the site where the probes contact the hemorrhoid. This explains why HemWell effectively eliminates very large Grade III & IV hemorrhoids while other treatments like HET are only effective for lesser grade disease where direct contact is required.
The FDA statement for use: Hemwellectomy acts by coagulative hemostasis, i.e. a process initiated by vasospasm, mechanical constriction of blood flow, ligating of the hemorrhoid’s circulation. The veins without smooth muscle remain open, allowing blood to leave the hemorrhoid. This is confirmed visually by the hemorrhoid’s immediate shrinkage and relatively intact overlying mucosa observed by the GI performing the procedure.
The immediate shrinkage following Hemwellectomy is confirmation that vasospasm, ligation within the hemorrhoid’s feeder vessels but not within the veins allows the hemorrhoid to decrease in size as blood leaves the cushion prior to thrombosis.
