InclusionMD’s c-PRP Concentrating devices are class II medical devices with 510(k) clearance, which are relabeled and distributed on behalf of our manufacturer (510(k) Number: BK170136); our device manufacturer maintains a quality management system that’s ISO 13485 certified as well. All c-PRP collection tubes are manufactured using Crystel-PET and contain a polymeric, thixotropic gel separator with an optimized specific gravity of 1.05g/cm3 that helps maximize platelet, monocyte and growth factor concentrations while eliminating RBCs and trapping WBCs in the gel separator. Our PRP devices undergo a triple sterilization method using Cobalt^60 gamma irradiation technology. After sterilizing twice, our collection devices undergo a depyrogenation process in a unidirectional dry heat tunnel, before undergoing their third gamma irradiation sterilization. The quality and safety of our devices exceed the industry standards of our competitors and uphold all regulatory standards and requirements.
The i7 Slow-Speed PRP Centrifuge provides ideal conditions for platelet-tube centrifugation. The fixed-angle, operating speed, centrifugal force, and delicate rotation all work cohesively to maintain platelet, α-granule, and growth factor integrity. The centrifuge is manufactured with unique shock isolators to dampen vibrations and provide an automatic balancing mechanism to keep the tubes level throughout the cycle. Further, it operates under 60 decibels, functions without emitting micro-carbon dust particles, and accelerates and decelerates delicately as not to add torque to the system. The i7 can spin up-to 4000 revolutions per minute (rpms), but we’ve seen the highest concentration of Platelets when tubes are spun between 3700-3800RPM for 8-10 min. This machine provides state-of-the-art mechanisms for exceptional and consistent platelet yields, is one of the most affordable centrifuges on the market, and optimized for our c-PRP tubes.
Although case studies are currently being conducted on our refined c-PRP systems, our previous PRP systems provided exceptional yields for platelets, growth factors, WBCs and RBCs. Our new systems have a more optimized concentration of ACD solution A, as well as a gel separator with a more optimal specific gravity. This allows RBCs to separate from the final platelet mixture without causing them to lyse. The thixotropic gel’s specific gravity, taken with the crystal glass tubes and centrifugation parameters, allow RBCs and granulocytes to move past the gel without initiating contact and potentially lysing. As the centrifuge spins, the crystal walls heat the gel and allow it to alter its dimensions. The hydrophilic walls of the tube provide a mechanism for adhesion of the gel, which minimizes its surface area in the horizontal plane and provides a seamless process for RBCs and other WBCs to separate to the bottom of the tube based on density, while granulocytes are forced into the gel separator and trapped away from the final PRP concentrate. By enhancing our manufacturing materials and conducting trials to determine our systems optimal centrifugal force, speed and spin time we’ve strengthened the quality of our products and services. The InclusionMD c-PRP Concentrating systems allow for the safe and rapid preparation of autologous platelet-rich plasma. Although our PRP systems are only indicated for mixture with autograft and/or allograft bone, as deemed necessary by the clinical use requirements, it is optimized for “off-label” dermatological and cosmetic point-of-care procedures based on the most current scientific literature.
Our next article in this series will provide more detailed insight about mechanisms of action and specific growth factor and cellular components involved in PRP for hair restoration, facial rejuvenation, and pigmentation disorders. After understanding the mechanisms which facilitate rejuvenation and repair, we will continue to explore the other parameters that impact PRP efficacy across various indications and specialities, such as pH, Temperature and the use of Calcium Chloride and other PRP activators. Sign up at the bottom of this page for updates through our newsletter and stay tuned! As always, feel free to reach out with any questions.
A special thank you to the students in the InclusionMD Internship Program for contributing to this review.