NEW YORK, Oct. 2, 2018 /PRNewswire/ -- Xtreem Pulse LLC is pleased to announce that PureFlow received 510K clearance from the FDA for chronic stable angina that is refractory to optimal anti-anginal medical therapy and without option for revascularization. Intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow, the device has also received approval from the European Medical Device Directive.
PureFlow is the result of decades of research on a concept called external counter-pulsation (ECP, EECP) and promises to be a major breakthrough in cardiovascular health and wellness.
Though PureFlow was originally designed to improve unhealthy cardiovascular function, the current design of the device improves the overall blood flow and VO2 MAX in healthy individuals as well. PureFlow has been used successfully by many athletes to promote optimal performance and recovery. Utilizing PassiveCardio™ technology, it helps users maintain their cardiovascular health.
Some of the unique features of PureFlow are
- Patented precise individual cuff control system
- SmoothTouch™ comfort technology
- Patented Triple Pump System
- First automatic ReverseFlow for a variety of lower extremity disorders
In a PureFlow session, the user lies comfortably while three sets of soft cuffs are wrapped around the calves, thighs, and buttocks. These are attached to a computer that monitors the heart, which triggers the cuffs to inflate and deflate in sync with the heartbeat. The treatment is not painful and the users feel a strong "hugging" sensation similar to a massage as the cuffs inflate.
"PureFlow is a revolutionary PassiveCardio™ technique to improve cardiovascular health for everyone, whether an elite athlete or deconditioned individual," said Andrew Barile. 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.
Visit us at MEDICA 2018 in Düsseldorf, Germany from 12 - 15 November.
About Xtreem Pulse LLC
Xtreem Pulse is healthcare technology company focused on advanced preventive health care and anti-aging products and solutions for wellness, spa, fitness and medical professionals. Designed in the USA and exclusively manufactured to highest quality in Japan.
SOURCE Xtreem Pulse LLC