United Health Products seeks FDAs PMA approval for HemoStyp device
Healthcare technologies and products developer United Health Products (UHP) has announced the submission of its Premarket Approval (PMA) application to the FDA for Class III approval of its HemoStyp device, used in surgical procedures.
Upon the receipt of PMA approval that confirms the safety and efficacy of a product, , the HemoStyp device can be used for surgical procedures in abdominal, cardiovascular, thoracic and vascular surgeries.
HemoStyp is an all-natural product that contains specifically formulated regenerated oxidised cellulose gauze to help the haemostasis (clotting) process when positioned on a cut or wound.
According to the company, a haemostasis device is an absorbable haemostatic agent or dressing that accelerates the clotting process of blood. The absorbable devices are intended for internal surgical use, and are classified under Class III devices.
HemoStyp is designed as an all-natural hemostatic product
UHP has designed HemoStyp as an all-natural hemostatic product to absorb exudate/drainage from wounds to help control bleeding.
HemoStyp has been formulated from oxidised, regenerated cellulose, which is found in the cellular structure of almost all plant matter.
In addition, HemoStyp is comprised of no potentially harmful chemicals or animal by-products and is hypoallergenic, unlike many other products in the wound care market.
The device is intended to help stopping the bleeding quicker than normal gauze and is claimed to be more effective alternative, and the oxidizing process makes the device a safe, effective, all-natural solution for rapid bleeding control.
Once the task is completed, HemoStyp gauze can be easily removed by dissolving it in water or saline solution, without disturbing the clotted surface or causing any re-bleeding.
The company is offering Hemostyp in different sizes and configurations to help control most types of bleeding including cuts, abrasions, lacerations, nose bleeds, dental surgeries, post dialysis treatment, and punctures.
UHP develops, manufactures, and markets patented hemostatic devices, for the healthcare and wound care sectors.