Arthrex ACP Double Syringe Pack x 5
Arthrex
PRP / Orthobiologic preparation systemAutologous conditioned plasma (ACP) / PRP double-syringe kit
Certifications
- CE Marked medical device for preparation of autologous platelet Rich plasma / autologous conditioned plasma in accordance with applicable EU / UK medical device regulations.
- Manufactured under an ISO 13485–compliant quality management system for medical devices (Arthrex, Inc.).
- Single Use, sterile device compliant with relevant standards for sterilisation and biocompatibility (as detailed in Arthrex technical documentation and regulatory submissions).
- CE Marked medical device for preparation of autologous platelet Rich plasma / autologous conditioned plasma in accordance with applicable EU / UK medical device regulations.
- Manufactured under an ISO 13485–compliant quality management system for medical devices (Arthrex, Inc.).
- Single Use, sterile device compliant with relevant standards for sterilisation and biocompatibility (as detailed in Arthrex technical documentation and regulatory submissions).
Autologous conditioned plasma (ACP) / PRP double-syringe kit
Description
The Arthrex ACP Double Syringe Pack x 5 contains five Arthrex ACP (Autologous Conditioned Plasma) double-syringe kits designed for the rapid, safe preparation of autologous platelet-rich plasma (PRP) / fluid PRF at the patient’s point of care. Each closed, sterile dual-syringe system allows blood to be drawn directly into the device, centrifuged and then separated so that platelet-rich plasma can be collected with minimal contamination risk. The system typically processes 10–15 ml of whole blood per kit and yields approximately 2–5 ml of PRP, which can be used in orthopaedics, sports medicine, aesthetic dermatology, hair restoration and other regenerative treatments. The ACP system is CE-marked, single-use and disposable, and is compatible with most standard tabletop centrifuges.
Bnefits
- Closed, sterile dual-syringe system for safe and rapid preparation of autologous PRP / fluid PRF
- Facilitates efficient concentration of platelets and growth factors from a small sample of the patient’s blood
- Minimises risk of contamination compared with open PRP preparation methods
- Typically yields 2–5 ml of PRP from 10–15 ml of whole blood (depending on protocol and patient factors)
- Compatible with most standard tabletop centrifuges used in clinics
- Single-use, disposable device supports high standards of infection control and patient safety
- CE-marked and clinically validated for use in orthopaedics, sports medicine and aesthetic / regenerative treatments
- Supports a wide range of indications including skin rejuvenation, scar management, hair restoration and joint therapy
- Intuitive design that is easy to integrate into clinical workflow with minimal training
Indications
- Preparation of autologous platelet-rich plasma (PRP) / autologous conditioned plasma (ACP) from peripheral blood at the point of care
- Use of PRP in orthopaedic and sports medicine indications (e.g. joint injuries, tendinopathies, osteoarthritis) according to local protocols
- Preparation of PRP / fluid PRF for aesthetic dermatology procedures such as skin rejuvenation, scar reduction and photo-ageing support
- Preparation of PRP for hair restoration / androgenic alopecia protocols in suitable patients
- Use of PRP with autograft and/or allograft bone (e.g. to improve handling characteristics in certain surgical procedures) as per official indications and local regulatory guidance
Composition
- Dual-chamber plastic syringe system (outer and inner syringe) designed for PRP/ACP separation
- Syringe volume typically 10–12 ml per kit (whole-blood draw capacity), yielding 2–5 ml PRP after centrifugation
- Medical-grade, sterile syringe components with integrated plunger and locking mechanism for separation
- Latex-free, single-use plastic materials (exact polymer composition as per Arthrex technical file, not publicly detailed)
- No anticoagulant supplied in the pack (sodium citrate or ACD-A, if required, must be purchased separately)
Formulation
- Non-pharmaceutical, single-use sterile medical device
- Closed double-syringe system for mechanical separation of non-homogenous fluids (whole blood) by centrifugation
- Designed to separate and retain the platelet-rich plasma fraction while excluding the majority of red and white blood cells
- Device only; no drugs or biologically active substances are preloaded in the syringe system
Packaging
- Pack of 5 Arthrex ACP double-syringe kits
- Each kit includes one sterile dual-chamber (double) syringe (typically 10–12 ml capacity) individually packaged
- Kits supplied sterile in blister packaging for single use
- Outer carton with product identification, lot number, expiry date and instructions for use
- Traceability labelling to support device tracking and patient records
Usage
- For medical use only; the Arthrex ACP Double Syringe System must be used by appropriately trained healthcare professionals following local regulations and Arthrex instructions for use.
- Prime the inner and outer syringes according to the manufacturer’s IFU; if using anticoagulant (e.g. ACD-A or sodium citrate), draw the recommended volume into the system before blood collection, as per protocol.
- Draw the required volume of the patient’s peripheral blood (commonly 10–15 ml) directly into the double syringe using a suitable blood collection needle (e.g. butterfly needle) in accordance with aseptic technique.
- Seal the syringe, then place it in a compatible tabletop centrifuge, ensuring correct balancing and rotor position as per the centrifuge manufacturer’s requirements and the Arthrex protocol (time and g-force / rpm).
- Centrifuge the syringe to separate the PRP / ACP fraction from red and white blood cells; after centrifugation, the platelet-rich plasma will be located in the outer syringe above the cellular components.
- Without opening the system, advance or retract the plunger as instructed to transfer and isolate the PRP / ACP into the collection chamber while leaving the red and white cell layers behind.
- Detach or use the outer syringe to draw up the PRP fraction for immediate clinical use, or transfer it into a separate sterile syringe if required by the procedure.
- Use the prepared PRP at the patient’s point of care within the time limits specified in the IFU (typically within 30 minutes if no anticoagulant is used, or within a few hours if anticoagulant is present).
- Dispose of all used syringes, needles and associated consumables as biohazardous clinical waste according to local infection-control and sharps disposal protocols.
- Do not reuse the device; each double syringe kit is strictly single use and must not be resterilised.
Contraindications
- The device must not be used in patients for whom autologous blood withdrawal or PRP treatment is contraindicated (e.g. certain coagulopathies, severe anaemia, uncontrolled systemic disease), according to clinical judgement and local guidelines.
- Do not use the device in patients with active systemic or local infection at or near the intended treatment site.
- Contraindications related to PRP therapy itself (e.g. some platelet or clotting disorders, certain autoimmune conditions, current anticoagulant therapy that cannot be safely managed) must be observed, even though they relate to the treatment and not the device mechanics.
- Do not use if the packaging is damaged, opened or past the expiry date, as sterility cannot be guaranteed.
- Do not reuse, resterilise or use the device in any manner other than that described in the Arthrex instructions for use.
Adverse Effects
- No direct adverse effects are expected from correct use of the sterile device itself; potential complications relate to blood draw and PRP injection procedures (e.g. pain, bruising, infection, bleeding, vasovagal reactions).
- Improper use (e.g. non-sterile technique, incorrect centrifugation, reuse of single-use components) may increase risk of contamination, infection or device failure.
- Inadequate separation or handling may result in suboptimal PRP quality or inconsistent platelet concentration, potentially affecting clinical outcomes.
Storage Conditions
- Store the unopened kits at room temperature in a clean, dry environment, generally between 15°C and 25°C, or as specified on the packaging.
- Protect from direct sunlight, excessive heat, and moisture.
- Keep in original outer carton and blister packaging until use to maintain sterility.
- Do not use after the expiry date printed on the packaging.
- Do not freeze or expose to conditions that could damage the plastic syringe components (e.g. crushing or bending).
Duration
Not directly applicable to the device itself. In clinical practice, the PRP/ACP preparation process typically takes only a few minutes (blood draw plus one centrifugation cycle), and the prepared PRP should be used at the point of care within the time specified in the instructions for use.
Onset
Not applicable to the device itself. Clinical onset and duration of effect depend on the specific PRP treatment protocol, indication (e.g. joint disease, skin rejuvenation, hair restoration) and patient factors, rather than the syringe system used to prepare the PRP.
