PureFlow System receives 510(K) clearance from FDA for chronic stable angina.- Xtreem Pulse.
Xtreem Pulse has announced that the PureFlow System has received 510(K) 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.
Comment: coronary blood flow can be increased 20% to 40% by increasing diastolic blood pressure. Intra-aortic balloon pump (IABP) counterpulsation is an invasive method of increasing coronary blood flow, while enhanced external counterpulsation (EECP) is a non-invasive method. EECP therapy has been approved by the United States Food and Drug Administration (FDA) (Class IIb) for management of refractory angina and heart failure.
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