DATE : 7 October 2019
VENUE : Redo Marketing Headquarter, Shah Alam.
TRAINER : Timur Veysel Dogrouk, Founder, Managing Director of T- Lab
WHAT OUR PRP KIT HAS MORE TO OFFER?
PRP HD Kit is not a Blood Storage Tube or Blood Seperation kit unlike the many other products. The requirements of CE Class IIb has been acquired.
Does not include Ficoll
Unfortunately, some IVD tubes are marketed as PRP products. IVD tubes’ intended use are diagnoses outside the human body. The section of the catalogues of these tubes express that “do not inject to humans” .
CE Class IIb Certificate
According to 93/42/EEC directive Annex IX and MEDDEV guidance document Classification of the Medical Devices MEDDEV 2.4/1 Rev 9, June 2010, expresses on Rule 3: Non-Invasive devices that modify biological or chemical composition of blood, body-liquids or other liquids intended for infusion into the body are in Class IIb. PRP HD Kit has CE Class IIb medical device certificate.
Not just a blood storage tube, but a real prp kit.
There are various products in the market sold as PRP tubes or collection of products along with PRP Tubes. As many of them are not certified to be used on PRP procedures, also some of tubes have certificate as “Blood Storage Tube” or “Blood Seperation Kit”.
But, PRP HD Kit is equipped with every necessary equipments to be used on PRP Procedures.
Blood Storage Tubes and Blood Seperation Kits do not include any anticoagulant. So, instructions lead the user to collect anticoagulant from outer sources that eliminates the standardization of anticoagulant quality and increases the risks of choosing the wrong anticoagulant. PRP HD Kit does not let the user to change the anticoagulant or have the risk of misusage of anticoagulant.
Due to strong centrifugal force, the clump formation of the platelets can occur. Re-suspension of the platelets helps to homogenize the platelets in the plasma milieu.
Cell-Cell interaction determines that the platelets’ role to become proaggregator and interact with the other cells around the microenviroment. Publications have shown that the PRP+RBC in collagen-induced activation leads ADP and ATP synthesis fivefold – sevenfold in comparison to PRP alone. LR+PRP or LP+PRP is depending on the doctor’s consultation to his/her patients. PRP HD Kit offers all to doctor’s choice.
Some kits have gel in the tubes. During centrifugation, gel keeps RBCs under the gel. But RBCs are bigger molecular structures than platelets and during the centrifugational movement of the cells, RBCs collect many Platelets under the gel along with RBCs. Also, it is a risk that the gel may be allergen. In some cases, there may be some risks to collect the gel inside the tubes and re-inject to patients. Due to those risks, PRP HD Tubes do not include gel.