Introducing MedGeneRx® HP 15 PRP - FDA-Cleared for Sale
PRP Kit Specifications 15mL Protocol
- FDA-Cleared, Class II Medical Device, 510(k)-Cleared
- Integrated anticoagulant- No ACD-A needed
- Industry leader in three critical areas:
Reproducible concentrations from consistent platelet recovery/85+%
Balanced pH
99% removal of RBCs
- Vacutainer system for simplified blood collectionical Device, 510(k)-Cleared
- Compatible with existing 30mm diameter centrifuges
- Single spin 15mL’s of whole blood
3mL’s high concentration PRP
5mL’s mid concentration PRP
Platelet-Rich Plasma (PRP Kit) Description
MedGeneRx® HP 15 PRP Kit is FDA-Cleared and indicated for the rapid preparation of autologous Platelet Rich Plasma (PRP) from a small sample of blood at the patient’s point -of-care.
SKU: ZG-PRP-HP15
MedGeneRx® HP 15 PRP Optional Accessory Kit:
- Single 10mL Luer Syringe
- Single 3mL Luer Syringe
- 21g Butterfly safety needle and vacutainer holder
- Additional vacutainer transfer holder
- Single 30g 1/2" needle
- Single male-to-male Luer-Lok syringe transfer connector
- Single tourniquet
- Single Band-aid (standard size)
- One 2x2 gauze packet
- Single alcohol pad
MedGeneRx® HP 15 PRP Kit is FDA-Cleared and indicated for the rapid preparation of autologous Platelet Rich Plasma (PRP) from a small sample of blood at the patient’s point -of-care.
SKU: ZG-PRP-HP15
MedGeneRx® HP 15 PRP Optional Accessory Kit:
(1) MedGeneRx® HP 15 Vacutainer
(2) 10cc Syringes
(1) 21g Butterfly Needle
(1) 3 inch 19g Spinal Needle
510(k) equivalence study conducted and the following mean results were achieved:
- Platelet Concentration Factor at 0 Hours = 4.1 – 4.5x baseline
- Platelet Concentration Factor at 1 Hour = 4.5 – 4.8x baseline
- Platelet Recovery % at 1 Hour = 61%
- RBC at 0 Hours = 0.01
- RBC at 4 Hours = 0.01
- pH at 0 Hours = 7.5
- pH at 4 Hours = 7.65
- Platelet Activation (Resting) at 0 Hours = 10.2%
- Platelet Activation (Stimulated ADP) at 0 Hours = 96.3%
- Platelet Aggregation at 0 Hours = 96.1%
- Platelet Aggregation at 4 Hours = 95.8%
- HCT at 0 Hours = 0.01%
- HCT at 4 Hours = 0.01%
- WBC at 0 Hours = 0.6
- WBC at 4 Hours = 0.6
510(k) equivalence study conducted and the following mean results were achieved:
• Platelet Concentration Factor at 0 hours = 3.8-4.1x baseline
• Platelet Concentration Factor at 1 Hour = 4.1-4.3 x baseline
• Platelet Recovery % at 1 hours = 53%
• RBC at 0 hours- 0.1
• RBC at 4 hours- 0.01
• pH at 0 hours = 7.59
• pH at 4 Hours = 7.69
• Platelet Activation resting at 0 hours= 9.7%
• Platelet Activation stimulated ADP 0 hours = 95.1%
• Platelet Aggregation at 0 hours = 95.1%
• Platelet Aggregation at 4 Hours = 94.8%
• HCT at 0 hours = 0.0 %
• HCT at 4 Hours = 0.0%
• WBC at 0 hours= 0.3
• WBC at 4 hours= 0.3
PRP Articles
Platelet Rich Plasma (PRP) Matrix Grafts
Abstract Platelet Rich Plasma (PRP) grafting techniques are now being utilized in musculoskeletal medicine with increasing frequency and effectiveness. Soft tissue injuries treated with PRP
Plasma Rich in Growth Factors to Treat an Articular Cartilage Avulsion- A Case Report
Abstract The application of an autologous plasma rich in growth factor~; is beneficial in restating connective tissues, as shown by clinical evidence in oral surgety
Biological Augmentation of Rotator Cuff Tendon Repair
Abstract A histologically normal insertion site does not regenerate following rotator cuff tendon-to-bone repair, which is likely due to abnormal or insufficient gene expression and/or
Abstract The use of regenerative therapies in sports medicine has been increasing with the success of biologics such as plateletrich plasma (PRP). We present the
Angels’ Garrett Richards sees progress in healing elbow
ANAHEIM, Calif. — Garrett Richards is expected to be ready for spring training after the Los Angeles Angels right-hander completed his instructional league work with
Application of PRP after arthroscopic cuff repair yielded structural, clinical healing
Patients with large rotator cuff tears had superior structural and clinical healing after arthroscopic repair with the application of moderately concentrated platelet-rich plasma, according to
Abstract BACKGROUND: Many treatment options for plantar fasciitis currently exist, some with great success in pain relief. The objective of our study was to compare
Effectiveness of Platelet-Rich Plasma in the Treatment of Tendinopathy: Response
Jane Fitzpatrick, MBBS, FACSP⇑, Max Bulsara, BSc(Hons), MSc, PhD and Ming Hao Zheng, MD, PhD, FRCPath, FRCPA, Jane Fitzpatrick, MBBS, FACSP (email: jane.fitzpatrick@research.uwa.edu.au). Authors’ Response: We reported “strong evidence
Amniotic Tissues for the Treatment of Chronic Plantar Fasciosis
Abstract Introduction. Allogeneic amniotic tissue and fluid may be used to treat chronic plantar fasciosis and Achilles tendinosis. This innovative approach involves delivering a unique
A Prospective Study of 20 Foot and Ankle Wounds- Medgenerx
Abstract We reviewed the background information and previous clinical studies that considered the use of allogeneic amniotic tissue and fluid (granulized amniotic membrane and
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