PRP-Tubes | VI - Density Life Platelets | PU 10 pcs.
VI - Density Life Platelets PRP tubes provide the simplest and most efficient method of collecting and preparing platelet-rich plasma (PRP) from patients' blood. Attention!
First class PRP tubes!
Safe and fast! Easiest method for obtaining high purity and autologous plasma!
VI - Density Life Platelets PRP tubes is a new generation product manufactured with advanced technology to improve the quality and efficiency of their use. They are all CE marked (93/42/EEC, updated by Directive 2007/47/EEC) and then validated according to numerous ISO certifications such as ISO 9001: 2008, EN ISO 13485: 2012 and EN ISO14971: 2009, ISO 10993 -1: 2009, ISO 10993-3: 2005 and SFDA.
1) Certified as medical devices of risk class IIa:
According to the provisions of Directive 93/42/EEC on medical devices, consumables used for the preparation of plasma for therapeutic purposes must meet certain requirements. In particular, plasma preparation by centrifugation requires tubes that are classified and certified as risk class IIa medical devices. However, to ensure the highest level of safety for the end user, some manufacturers certify these tubes as risk class IIb medical devices, which requires additional risk analysis and clinical studies of the product.
2) They contain a special separation gel developed by researchers at the University of Naples Federico II. The main physicochemical and biological properties of this gel are:
b) long-term stability in contact with the anticoagulant;
d) well-defined density.
Antikoagulans: Natriumcitrat 0,8 ml, Natriumcitrat PH 6,5 / 7
Approximately 4 / 4.5 ml of PRP can be obtained in each PRP tube.
The latter value is of particular importance, as research has shown that the density of the release gel should be about 1080 - 1077 g/cm³ to achieve the highest possible concentration of platelets in plasma. A decrease in this value leads to a reduction in the number of platelets contained in the plasma, and some subpopulations are completely eliminated. Researchers at the University of Naples have spent months of painstaking work producing a gel with optimal thixotropy and specific gravity that makes this possible:
- remove red blood cells almost completely from the plasma;
- obtain an optimal leukocyte concentration by lowering the granulocyte threshold and keeping the lymphocyte and monocyte concentration almost unchanged;
- obtain a platelet concentration twice that of whole blood
VI - Density Life Platelets is a modular medical product used for the production of platelet-rich plasma (PRP).
It has the following features:
- Pre-labeled tubes with red cap containing anticoagulant; Each tube holds 9 ml of blood and has a pre-calibrated vacuum for a ~9 ml blood sample.
- The tubes contain a separation gel based on an inert polymer and an anticoagulant.
- The separation gel is required for separation between platelet-enriched serum and red blood cells during centrifugation.
VI - Density Life Platelets - PRP tubes allow easy, safe and fast preparation of blood components (e.g. platelet gel, fibrin gel, bone marrow cell gel) and is intended for use of autologous blood products.
The rationale for using this medical device is to administer locally high concentrations of growth factors, such as those found in platelet concentrate. It may also provide cells involved in repair or support tissue and temporary fibrin scaffolding and cell migration.
PRP tubes must be used by specially trained medical personnel and possibly under the responsibility of a physician.
Therapeutic efficacy depends on the intrinsic quality and manufacturing of the blood components. This medical device enables the preparation and
Activation (gelation) of the blood components. VI - Density Life Platelets is not therapeutic in itself. The main indications for the use of this
Medical product are treatment of acute wounds, chronic ulcers of the skin, subcutaneous or mucocutaneous tissue and bone injuries, subcutaneous injections/fillers and strengthening of hair roots.
The method based on this preparation is called "BUFFY COAT" and requires PRP tubes, which are different from the "EMPTY TEST" (simple vacuum blood collection tube), which does not produce a concentrate but a serum. These tubes are not able to sediment the blood with high precision and produce a high concentration of PRP. Furthermore, they also do not allow to extract only the intermediate layer (PRP).
In addition, the plastic of the simple vacuum blood collection tubes contains micronized silicone, which can also produce platelet activation. All of this results in platelet-free serum after the centrifugation process, which cannot be used for PRP.
VI - Density Life Platelets - PRP tubes are not made of plastic and do not contain micronized silicone!
The composition is optimally balanced to achieve maximum biological effect. Platelet rich plasma (PRP) is also known as platelet autologous platelet gel), growth factor rich plasma (PRGF) or platelet concentrate (PC). It is essentially an increase in the concentration of autologous platelets contained in a small amount of plasma, after centrifugation of the patient's blood.
PRP tubes are available in the following vacuum capacities: 9ml.
Fields of application
MAXILLO - FACIAL SURGERY
Mandibular reconstructions, dental implants, tonal and oropharyngeal fissures;
Neck and head surgery; facial or nasal fractures;
Lesions of dental alveoli; breast augmentation; mandibular reconstruction; bone graft; oronasal fistula; lip repair; rhinoplasty and septal rhinoplasty; facial fractures
PLASTIC, RECONSTRUCTIVE, AESTHETIC SURGERY
Skin flaps, muscle-skin reconstruction, mammoplasty; face and neck lift; musculocutaneous flaps and reconstruction; chronic ulcers; breast reconstruction and mammoplasty; craniofacial reconstruction; adjunctive for laser facial treatments
Pseudoarthrosis, osteosynthesis, bone implants, titanium prosthesis implants
Vertebral reconstructions; burr holes and craniectomy; cerebrospinal fluid loss
Vascular and cardiac surgery
Sternal repair; arterial bypass; arterial reconstruction; broncho pleural fistula
Corneal ulcers and wounds; macular lesion repairs (with hyperconcentrated platelets).
Regeneration of the hair roots
GENERAL MEDICINE, GERIATRICS, DIABETOLOGY, HEMATOLOGY, GENERAL SURGERY, DERMATOLOGY, RADIOTHERAPY
are specialties in which ulcers or acute or chronic lacerations, primary or secondary, could find therapeutic support in the use of platelet gel.
The medical device may only be used by experienced personnel and also only under certain conditions.
Use the PRP with special caution in the following cases:
- acute or chronic infections at the surgical site;
- uncontrolled metabolic diseases such as diabetes, osteomalacia, thyroid dysfunction, severe kidney or liver diseases;
- Long-term cortisone therapy;
- Autoimmune diseases;
- Radiation therapy.
Patients with congenital or acquired functional platelet defects may release fewer growth factors.
In thrombocytopenia, it is very difficult to obtain a platelet-rich concentrate for clinical use. The platelet gel is reabsorbed in a few days. No toxicity phenomenon has been described in tissues treated with gel.
Normal monitoring procedures or prophylaxis against infectious complications should be used. Growth factors from platelets induce cell proliferation.
The use of platelet gel is contraindicated if malignant degenerative lesions are suspected. To ensure tissue regeneration, PRP must be introduced only into vital tissue and in direct contact with the tissue (if necessary, by applying microtoning to the surface of the tissue).
By following these instructions for use, this medical device can produce PRP with a platelet concentration 4-5 times higher than the original blood sample (1 x 106 platelets / microliter ± 20%). Growth factors and chemotactic mediators from platelets are mainly released passively (i.e., without platelet activation). Therefore, platelet gel can be produced from the blood of patients taking oral anticoagulants, heparin, calcium heparin, platelet aggregation inhibitors, and cyclooxygenase inhibitors.
Part of the release of growth factors could depend on the activation state of platelets. It is therefore advisable to wait for a delay in the release of the
Growth Factors if the patient is taking cyclooxygenase inhibitors or anti-adherent platelets. There are no known interactions with systemic or topical agents. Intended use does not include adding medications to platelet gel. When platelet gel is used for bone regeneration, the gel may be used with certified animal bone or certified biocompatible materials.
The preparation of PRP consists in the collection of autologous venous blood (of the patient to be treated), which is then centrifuged and concentrated (method called BUFFY COAT).
After blood collection, centrifugation (rotation/centrifugal force depending on the centrifuge) is performed until three layers are obtained:
- platelet-poor plasma (platelet-poor plasma PPP)
- platelet-rich plasma (platelet-rich plasma-PRP)
- red blood cells
Set the centrifuge to the following parameters:
1200 RCF (g) (For Hettich EBA 200 to 3400 rpm) for 7 minutes for angular or inclined rotor centrifuges
To determine the relative centrifugal acceleration (RCF), or to calculate the revolutions per minute (RPM), you can use our converters
VI - Density Life Platelets PRP tubes is a new generation product manufactured with advanced technology to improve the quality and efficiency of their use. They are all CE marked (93/42/EEC, updated by Directive 2007/47/EEC) and then validated according to numerous ISO certifications such as ISO 9001: 2008, EN ISO 13485: 2012 and EN ISO14971: 2009, ISO 10993 -1: 2009, ISO 10993-3: 2005 and SFDA
The PRP tubes are sterile primary packaging. Their packaging takes place in a laminar flow environment and is certified as a Class IIb medical device registered with the Ministry of Health under the national registration number with the CND classification