Tag

stem cell
Method of Ratios and PLT

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part Two

In the previous post, I had shared a couple of comments from physicians (Drs. Sairam Atluri and Dr. Edward Marcheschi) that had been made on the trio of posts on the Arthrex Angel in which I concluded that the Arthrex Angel system was a lemon as a PRP/BMC processing technology. In exploring aspects of the...
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Arthrex Angel and Method of Ratios

Comments from Physicians on the Arthrex Angel Lemon/Lemonade Posts Highlight the Utility of the Method of Ratios – Part One

The posts that I write are available on the Greyledge website and are also distributed on LinkedIn. I would like to share a couple of LinkedIn comments from physicians who responded to the last three posts that have covered this question: Is the Arthrex Angel PRP/BMC processing system a lemon or has Arthrex’s marketing group made...
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Arthrex Angel System

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Three

In the previous two posts (Part One and Part Two), I have reviewed aspects of the performance of the Arthrex Angel system, which is being marketed to orthopedic surgeons to produce PRP and BMC for therapeutic treatments. I have covered the basics of the system and reviewed data from a publication that compared the cellular...
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Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part Two

In the previous post, I referred to comments that surgeons had shared with me at the AOSSM conference in early July about the Arthrex Angel system, which Arthrex markets to produce hematocrit (Hct)-specific PRP and BMC preparations. None of the surgeons I asked was able to provide any evidence that specific Hct levels were of...
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Arthrex Angel System Hct

Is the Arthrex Angel System a Lemon or Have They Made Lemonade? Part One

Recently, I staffed Greyledge’s booth at the AOSSM meeting held in San Diego, CA in early July. And I have to say it was an interesting experience due to the number of enquires I fielded from physicians who wanted to know if the Greyledge manual processing method in a biological safety cabinet with hemoanalysis of...
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Cord Blood Derived HCT

Cord Blood-derived HCT/Ps Remain ‘351 Category Products – Part One

Back in mid-February, I was at the IOF Conference and was a part of a panel discussing various aspects of the questionable regulatory compliance by companies selling products that contain cord blood-derived components, including viable cells, among other issues. I was shocked to learn of the extent that the free-for-all in regenerative medicine involved donor cord...
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Greyledge Hemoanalytic Data

Practical Implications for Physicians Wanting to Use the Lipogems System for Processing Lipoaspirate Part One

In the last two posts (When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One andWhen Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two), I reviewed a situation involving a 510(k)-cleared device/kit for mechanically disrupting a patient’s adipose tissue (i.e.,...
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Amniotic Fluid-derived Information

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part Two

In the previous post When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One, I introduced what I think is a curious situation that has resulted from instructions the FDA provided to physicians on how to review the standards outlined in 1271.15(b) to see if they can invoke the...
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Lipogems Adipose Tissue

When Fat Hits the Regulatory Fan: Mechanical Disruption of Adipose Tissue with the Lipogems System Part One

During my previous review(see posts): When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two of important and relevant points the FDA made in the two Guidances that were issued on...
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When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part Two

In the previous post: When the Fat Hits the Regulatory Fan: Processing Adipose Tissue in the “Such HCT/P” Era Part One, I started reviewing relevant statements that I think might apply to adipose tissue in the two final Guidances the FDA issued on November 16, 2017 (see my views and the link below): Winners and...
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