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Estar Medical Seeks To Expand Their Distribution Network

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Estar Medical Seeks To Expand Their Distribution Network

January 02
22:48 2020
Estar Medical Seeks To Expand Their Distribution Network
Estar is widely known for their products involving the preparation of Platelet Rich Plasma (PRP) used under various trade names and injected into patients through their Physicians network, but what about their manufacturing site?

Fort Lauderdale, Florida – January 2, 2020 – As treatments with PRP, Platelet Rich Plasma, are becoming more and more commonplace in view of its efficacy, medical devices used for PRP preparation are under more scrutiny by regulatory bodies, medical doctors and patients. 

Even though it has been shown that the PRP procedure is very safe using cleared/registered devices, using non-conforming devices, in addition to being illegal, puts patients unnecessary at risk, e.g. contaminated devices, non-pyrogen free or In Vitro Diagnostics (IVD) devices. Even for approved devices, regulatory authorities have sometimes not yet had the opportunity to inspect the manufacturing site, especially if such site is based outside the U.S or Europe*. 

It is an easy matter for a company to produce flashy marketing materials, but do their facilities live up to their purported image and have them been inspected by regulatory authorities? 

Distributors and Physicians should do more than just attend trade shows to determine if the medical device they are using is approved for PRP preparation and even where it is manufactured and under what conditions. It may not always be practical for a USA based physician to visit a facility on the other side of the globe. It should be thoroughly scrutinized to see if their medical devices have been approved by the likes of the FDA or a European Certifying Authority and if their manufacturing plant has been inspected. There may or may not be images of their production facility shown on their website. 

Estar Medical is best known for: 

  • Eclipse PRP distributed by Eclipse Aesthetics (Eclipse MedCorp)
  • Tropocells PRP/PRF/TRS
  • Cellenis PRP/PRF/TRS
  • MyCells 

The Estar Medical manufacturing facility in Israel:

For information, visit: https://prdistributionco.com/

* For example, the U.S. House of Representatives’ Energy & Commerce Committee letter of June 28, 2019 and the Government Accountability Office’s (“GAO”) most recent High Risk List, have issued concerns over FDA’s oversight of foreign manufacturers of medical products. The GAO report found that in addition to other open recommendations, “FDA should complete its efforts to inspect all establishments without an inspection history and ensure all establishments continue to be inspected at an appropriate frequency.”

Media Contact
Company Name: PRD Media Group
Contact Person: Media Relations
Email: Send Email
Phone: 305.560.5786
Address:1338 GRAND AVE # 115
City: Fort Lauderdale
State: FL
Country: United States
Website: prdistributionco.com/