ManaMed Inc., based in Santa Ana, California, is pleased to announce that its first FDA-approved portable and tubeless DVT (deep vein thrombosis) prevention device is now available throughout the United States.
ManaMed’s DVT Prevention Device Available in U.S.
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“We at ManaMed are thrilled that our innovative PlasmaFlow DVT prevention device is available to help mitigate the risk to 600,000-plus new cases of DVT every year in the USA,” says Trevor Theriot, co-founder and chief executive officer of ManaMed, in the September 21, 2017 news release. Theriot adds: “Blood Clots are a silent killer in the medical industry and we decided to up the fight against DVT related deaths.”
As the company wrote in its news release, “PlasmaFlow is the first FDA-approved portable and tubeless sequential device with multiple pressure functions. Designed for optimal results and patient comfort, PlasmaFlow features innovative step-up-technology, user-friendly one-button operation, soft cuffs made of high-grade medical material, up to 10 hours of battery life, rechargeable, two LCD screens with timer and verification of pressure, and graduated and asymmetric compression for maximum benefit.”
“A thriving demand for ease in treatment is provided by PlasmaFlow. Tubeless and portable, PlasmaFlow is intended for use at home or at the hospital to help prevent the onset of DVT in patients by stimulating blood flow in the extremities. PlasmaFlow can be used to prevent DVT, enhance blood circulation, reduce post-operative pain and swelling, reduce wound healing time, aid in the treatment of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiently and reduction of edema in the lower limbs. The device can also be used as an aid in the prophylaxis for DVT by people stationary for long periods of time.”
Trevor Theriot commented to OTW, “The most interesting moment for ManaMed was going through the FDA approval process. It was a very long process but we were able to achieve that task. What was interesting is that we received FDA approval for PlasmaFlow on April Fool’s day. We thought someone was playing a joke on us.”
“I want the surgeons to know that the greatest risk is not taking action. It is more difficult for a surgeon to deal with the complications of a hospital acquired blood clot than it is to write a prescription for PlasmaFlow or dispense it out of their practice.”
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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