Preventive healthcare tech company Xtreem Pulse said today it won FDA 510(k) clearance for its PureFlow system designed to treat refractory chronic stable angina.
The New York-based company said that the system was designed on a concept called external counter-pulsation, and was originally designed to improve unhealthy cardiovascular function. The company also claims the system improves overall blood flow and VO2 max.
Xtreem Pulse said that the PureFlow system features cuffs designed to wrap around the calves, thighs and buttocks of a user while they’re laying down. The cuffs inflate and deflate in sync with a user’s heart beat, the company said, which it claims improves cardiovascular function.
“PureFlow is a revolutionary PassiveCardio technique to improve cardiovascular health for everyone, whether an elite athlete or deconditioned individual. After years of trials and tireless effort, we are thrilled to bring this revolutionary device to market and so excited to announce its FDA approval now. PureFlow will considerably impact and improve the lives of anyone who is trying to increase their cardiovascular health, from an elite athlete to a deconditioned individual,” CEO Andrew Barile said in a press release.
The post FDA clears Xtreem Pulse counter pulsation system appeared first on MassDevice.
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